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1. “Click and mortar” opportunities for digitization and consumerism in trials

Author

Randell, Rachel L., Hornik, Christoph P., Curtis, Lesley, Hernandez, Adrian F., Denwood, Tom, Nebeker, Camille, Sugarman, Jeremy, Tyl, Benoit, Murakami, Masahiro, Willberforce, Leslie O, Pagato, Sherry, Vedin, Ola, Andersson, Tomas, Carrasquillo, Olveen, Dolor, Rowena, Kollins, Scott H., Pellegrino, Jill, and Ranney, Megan L.

Published
2023

2. Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ)

Author

Naggie, Susanna, Milstone, Aaron, Castro, Mario, Collins, Sean P, Lakshmi, Seetha, Anderson, Deverick J, Cahuayme-Zuniga, Lizbeth, Turner, Kisha Batey, Cohen, Lauren W, Currier, Judith, Fraulo, Elizabeth, Friedland, Anne, Garg, Jyotsna, George, Anoop, Mulder, Hillary, Olson, Rachel E, O'Brien, Emily C, Rothman, Russell L, Shenkman, Elizabeth, Shostak, Jack, Woods, Christopher W, Anstrom, Kevin J, Hernandez, Adrian F, and Program, HERO Research

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Emerging Infectious Diseases, Lung, Infectious Diseases, Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Humans, COVID-19, SARS-CoV-2, Hydroxychloroquine, Pre-Exposure Prophylaxis, COVID-19 Drug Treatment, Health Personnel, Treatment Outcome, Health care workers, Trial design, HERO Research Program, Microbiology, Medical Microbiology, Public Health and Health Services, Clinical sciences, Epidemiology, Public health
Abstract

ObjectivesTo determine whether hydroxychloroquine (HCQ) is safe and effective at preventing COVID-19 infections among health care workers (HCWs).MethodsIn a 1: 1 randomized, placebo-controlled, double-blind, parallel-group, superiority trial at 34 US clinical centers, 1360 HCWs at risk for COVID-19 infection were enrolled between April and November 2020. Participants were randomized to HCQ or matched placebo. The HCQ dosing included a loading dose of HCQ 600 mg twice on day 1, followed by 400 mg daily for 29 days. The primary outcome was a composite of confirmed or suspected COVID-19 clinical infection by day 30, defined as new-onset fever, cough, or dyspnea and either a positive SARS-CoV-2 polymerase chain reaction test (confirmed) or a lack of confirmatory testing due to local restrictions (suspected).ResultsStudy enrollment closed before full accrual due to recruitment challenges. The primary end point occurred in 41 (6.0%) participants receiving HCQ and 53 (7.8%) participants receiving placebo. No difference in the proportion of participants experiencing clinical infection (estimated difference of -1.8%, 95% confidence interval -4.6-0.9%, P = 0.20) was identified nor any significant safety issues.ConclusionOral HCQ taken as prescribed appeared safe among HCWs. No significant clinical benefits were observed. The study was not powered to detect a small but potentially important reduction in infection.Trial registrationNCT04334148.

Published
2023

4. Dapagliflozin and Timing of Prior Heart Failure Hospitalization: A Patient-Level Meta-Analysis of DAPA-HF and DELIVER

Author

Butt, Jawad H., Jhund, Pardeep S., Docherty, Kieran F., Claggett, Brian L., Vaduganathan, Muthiah, Bachus, Erasmus, Hernandez, Adrian F., Lam, Carolyn S.P., Inzucchi, Silvio E., Martinez, Felipe A., de Boer, Rudolf A., Kosiborod, Mikhail N., Desai, Akshay S., Køber, Lars, Ponikowski, Piotr, Sabatine, Marc S., Solomon, Scott D., and McMurray, John J.V.

Published
2024
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6. Framework of the strengths and challenges of clinically integrated trials: An expert panel report

Author

Peters, Anthony E., Jones, W. Schuyler, Anderson, Brian, Bramante, Carolyn T., Broedl, Uli, Hornik, Christoph P., Kehoe, Lindsay, Knowlton, Kirk U., Krofah, Esther, Landray, Martin, Locke, Trevan, Patel, Manesh R., Psotka, Mitchell, Rockhold, Frank W., Roessig, Lothar, Rothman, Russell L., Schofield, Lesley, Stockbridge, Norman, Trontell, Anne, Curtis, Lesley H., Tenaerts, Pamela, and Hernandez, Adrian F.

Published
2024
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8. Angiotensin Receptor Neprilysin Inhibition and Associated Outcomes by Race and Ethnicity in Patients With Heart Failure With Reduced Ejection Fraction: Data From CHAMP‐HF

Author

Chapman, Brittany, Hellkamp, Anne S, Thomas, Laine E, Albert, Nancy M, Butler, Javed, Patterson, J Herbert, Hernandez, Adrian F, Williams, Fredonia B, Shen, Xian, Spertus, John A, Fonarow, Gregg C, and DeVore, Adam D

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Cardiovascular, Clinical Research, Heart Disease, angiotensin receptor neprilysin inhibitor, heart failure, population groups, registries, sacubitril/valsartan, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

Background There are limited data on the use of angiotensin receptor neprilysin inhibitors (ARNIs) in minority populations with heart failure (HF) with reduced ejection fraction. We used data from the CHAMP-HF (Change the Management of Patients With Heart Failure) registry to evaluate ARNI initiation and associated changes in health status and clinical outcomes across different races and ethnicities. Methods and Results CHAMP-HF was a prospective, observational registry of US outpatients with chronic HF with reduced ejection fraction. We compared patients starting ARNI with patients not starting ARNI using a propensity-matched analysis. Patients were grouped as Hispanic, non-Hispanic Black, non-Hispanic White, or non-Hispanic other individuals, where "non-Hispanic other" consists of all patients who did not identify as Hispanic, Black, or White. Health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire. Outcomes were analyzed with multivariable models that included race and ethnicity, ARNI initiation, and an interaction term between race and ethnicity and ARNI initiation. Cox proportional hazards models were used for death/HF hospitalization, and multiple regression was used for change in Kansas City Cardiomyopathy Questionnaire score. The analysis included 1516 patients, with 758 patients in each group (ARNI and no ARNI). Changes in Kansas City Cardiomyopathy Questionnaire score after ARNI initiation were similar among all race and ethnicity groups (mean [SD], non-Hispanic White individuals, 3.5 [19.0]; non-Hispanic Black individuals, 2.0 [17.0]; non-Hispanic other individuals, 5.5 [20.3]; and Hispanic individuals, 3.2 [20.1]), with no statistically significant interaction between race and ethnicity and ARNI initiation (P=0.21). There was similarly no statistically significant interaction between race and ethnicity and ARNI initiation for HF hospitalization (P=0.82) or all-cause mortality (P=0.92). Conclusions In a large registry of outpatients with HF with reduced ejection fraction, the association between ARNI initiation and outcomes did not differ by race and ethnicity. These data support the use of ARNI therapy for chronic HF with reduced ejection fraction irrespective of race and ethnicity.

Published
2022

9. Interleukin-6 and Cardiovascular Events in Healthy Adults: MESA

Author

Khan, Muhammad Shahzeb, Talha, Khawaja M., Maqsood, Muhammad Haisum, Rymer, Jennifer A., Borlaug, Barry A., Docherty, Kieran F., Pandey, Ambarish, Kahles, Florian, Cikes, Maja, Lam, Carolyn S.P., Ducharme, Anique, Voors, Adrian A., Hernandez, Adrian F., Lincoff, A. Michael, Petrie, Mark C., Ridker, Paul M., and Fudim, Marat

Published
2024
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11. Left Ventricular Function, Congestion, and Effect of Empagliflozin on Heart Failure Risk After Myocardial Infarction

Author

Udell, Jacob A., Petrie, Mark C., Jones, W. Schuyler, Anker, Stefan D., Harrington, Josephine, Mattheus, Michaela, Seide, Svenja, Amir, Offer, Bahit, M. Cecilia, Bauersachs, Johann, Bayes-Genis, Antoni, Chen, Yundai, Chopra, Vijay K., Figtree, Gemma, Ge, Junbo, Goodman, Shaun G., Gotcheva, Nina, Goto, Shinya, Gasior, Tomasz, Jamal, Waheed, Januzzi, James L., Jeong, Myung Ho, Lopatin, Yuri, Lopes, Renato D., Merkely, Béla, Martinez-Traba, Monica, Parikh, Puja B., Parkhomenko, Alexander, Ponikowski, Piotr, Rossello, Xavier, Schou, Morten, Simic, Dragan, Steg, Philippe Gabriel, Szachniewicz, Joanna, van der Meer, Peter, Vinereanu, Dragos, Zieroth, Shelley, Brueckmann, Martina, Sumin, Mikhail, Bhatt, Deepak L., Hernandez, Adrian F., and Butler, Javed

Published
2024
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14. Drug development for major chronic health conditions—aligning with growing public health needs: Proceedings from a multistakeholder think tank

Author

Krychtiuk, Konstantin A., Andersson, Tomas LG, Bodesheim, Ulrike, Butler, Javed, Curtis, Lesley H., Elkind, Mitchell, Hernandez, Adrian F., Hornik, Christoph, Lyman, Gary H., Khatri, Pooja, Mbagwu, Michael, Murakami, Masahiro, Nichols, Gwen, Roessig, Lothar, Young, Anne Quinn, Schilsky, Richard L., and Pagidipati, Neha

Published
2024
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15. Contemporary Use and Implications of Beta-Blockers in Patients With HFmrEF or HFpEF: The DELIVER Trial

Author

Peikert, Alexander, Bart, Bradley A., Vaduganathan, Muthiah, Claggett, Brian L., Kulac, Ian J., Kosiborod, Mikhail N., Desai, Akshay S., Jhund, Pardeep S., Lam, Carolyn S.P., Inzucchi, Silvio E., Martinez, Felipe A., de Boer, Rudolf A., Hernandez, Adrian F., Shah, Sanjiv J., Petersson, Magnus, Langkilde, Anna Maria, McMurray, John J.V., Solomon, Scott D., and Vardeny, Orly

Published
2024
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17. Identifying a stable and generalizable factor structure of major depressive disorder across three large longitudinal cohorts

Author

Schilsky, Richard L., Allen, Jennifer, Anderson, MaryAnn, Anstrom, Kevin, Araujo, Lucus, Arges, Kristine, Ardalan, Kaveh, Baldwin, Bridget, Balu, Suresh, Bashir, Mustafa R., Bhapkar, Manju, Bigelow, Robert, Black, Tanya, Blanco, Rosalia, Bloomfield, Gerald, Borkar, Durga, Bouk, Leah, Boulware, Ebony, Brugnoni, Nikki, Campbell, Erin, Campbell, Paul, Carin, Larry, Cassella, Tammy Jo, Cates, Tina, Montgomery, Ranee Chatterjee, Christian, Victoria, Choong, John, Cohen-Wolkowiez, Michael, Cook, Elizabeth, Cousins, Scott, Crawford, Ashley, Datta, Nisha, Daubert, Melissa, Davis, James, Dirkes, Jillian, Doan, Isabelle, Dockery, Marie, Douglas, Pamela S., Duckworth, Shelly, Dunham, Ashley, Dunn, Gary, Ebersohl, Ryan, Eckstrand, Julie, Fang, Vivienne, Flora, April, Ford, Emily, Foster, Lucia, Fraulo, Elizabeth, French, John, Ginsburg, Geoffrey S., Green, Cindy, Greene, Latoya, Guptill, Jeffrey, Hamel, Donna, Hamill, Jennifer, Harrington, Chris, Harrison, Rob, Hedges, Lauren, Heidenfelder, Brooke, Hernandez, Adrian F., Heydary, Cindy, Hicks, Tim, Hight, Lina, Hopkins, Deborah, Huang, Erich S., Huh, Grace, Hurst, Jillian, Inman, Kelly, Janas, Gemini, Jaffee, Glenn, Johnson, Janace, Keaton, Tiffanie, Khouri, Michel, King, Daniel, Korzekwinski, Jennifer, Koweek, Lynne H., Kuo, Anthony, Kwee, Lydia, Landis, Dawn, Lipsky, Rachele, Lopez, Desiree, Lowry, Carolyn, Marcom, Kelly, Marsolo, Keith, McAdams, Paige, McCall, Shannon, McGarrah, Robert, McGugan, John, Mee, Dani, Mervin-Blake, Sabrena, Mettu, Prithu, Meyer, Mathias, Meyers, Justin, Miller, Calire N., Moen, Rebecca, Muhlbaier, Lawrence H., Murphy, Michael, Neely, Ben, Newby, L. Kristin, Nicoldson, Jayne, Nguyen, Hoang, Nguyen, Maggie, O'Brien, Lori, Onal, Sumru, O'Quinn, Jeremey, Page, David, Pagidipati, Neha J., Parikh, Kishan, Palmer, Sarah R., Patrick-Lake, Bray, Pattison, Brenda, Pencina, Michael, Peterson, Eric D., Piccini, Jon, Poole, Terry, Povsic, Tom, Provencher, Alicia, Rabineau, Dawn, Rich, Annette, Rimmer, Susan, Schwartz, Fides, Serafin, Angela, Shah, Nishant, Shah, Svati, Shields, Kelly, Shipes, Steven, Shrader, Peter, Stiber, Jon, Sutton, Lynn, Swamy, Geeta, Thomas, Betsy, Torres, Sandra, Tucci, Debara, Twisdale, Anthony, Walker, Brooke, Whitney, Susan A., Williamson, Robin, Wilverding, Lauren, Wong, Charlene A., Wruck, Lisa, Young, Ellen, Perlmutter, Jane, Krug, Sarah, Bowman-Zatzkin, S. Whitney, Assimes, Themistocles, Bajaj, Vikram, Cheong, Maxwell, Das, Millie, Desai, Manisha, Fan, Alice C., Fleischmann, Dominik, Gambhir, Sanjiv S., Gold, Garry, Haddad, Francois, Hong, David, Langlotz, Curtis, Liao, Yaping J., Lu, Rong, Mahaffey, Kenneth W., Maron, David, McCue, Rebecca, Munshi, Rajan, Rodriguez, Fatima, Shashidhar, Sumana, Sledge, George, Spielman, Susie, Spitler, Ryan, Swope, Sue, Williams, Donna, Pepine, Carl J, Lantos, John D, Pignone, Michael, Heagerty, Patrick, Beskow, Laura, Bernard, Gordon, Abad, Kelley, Angi, Giulia, Califf, Robert M., Deang, Lawrence, Huynh, Joy, Liu, Manway, Mao, Cherry, Magdaleno, Michael, Marks, William J., Jr., Mega, Jessica, Miller, David, Ong, Nicole, Patel, Darshita, Ridaura, Vanessa, Shore, Scarlet, Short, Sarah, Tran, Michelle, Vu, Veronica, Wong, Celeste, Green, Robert C., Hernandez, John, Benge, Jolene, Negrete, Gislia, Sierra, Gelsey, Schaack, Terry, Tseng, Vincent W.S., Tharp, Jordan A., Reiter, Jacob E., Ferrer, Weston, Hong, David S., Doraiswamy, P. Murali, and Nickels, Stefanie

Published
2024
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18. Heart Failure, Investigator-Reported Sleep Apnea and Dapagliflozin: A Patient-Level Pooled Meta-Analysis of DAPA-HF and DELIVER

Author

BUTT, JAWAD H., JERING, KAROLA, DE BOER, RUDOLF A., CLAGGETT, BRIAN L., DESAI, AKSHAY S., HERNANDEZ, ADRIAN F., INZUCCHI, SILVIO E., JHUND, PARDEEP S., KØBER, LARS, KOSIBOROD, MIKHAIL N., LAM, CAROLYN S.P., MARTINEZ, FELIPE A., PONIKOWSKI, PIOTR, SABATINE, MARC S., SHAH, SANJIV J., VADUGANATHAN, MUTHIAH, LANGKILDE, ANNA MARIA, BENGTSSON, OLOF, PETERSSON, MAGNUS, SJÖSTRAND, MIKAELA, WILDERÄNG, ULRICA, SOLOMON, SCOTT D., and MCMURRAY, JOHN J.V.

Published
2024
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19. Identifying patients at increased risk for poor outcomes from heart failure with reduced ejection fraction: the PROMPT‐HF risk model

Author

DeVore, Adam D, Hill, Claude Larry, Thomas, Laine E, Albert, Nancy M, Butler, Javed, Patterson, J Herbert, Hernandez, Adrian F, Williams, Fredonia B, Shen, Xian, Spertus, John A, and Fonarow, Gregg C

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Patient Safety, Heart Disease, Clinical Research, Cardiovascular, 2.1 Biological and endogenous factors, Aetiology, Health Status, Heart Failure, Hospitalization, Humans, Quality of Life, Stroke Volume, Heart failure, Left ventricular dysfunction, Quality of life, Risk model, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

AimsWe aimed to develop a risk prediction tool that incorporated both clinical events and worsening health status for patients with heart failure (HF) with reduced ejection fraction (HFrEF). Identifying patients with HFrEF at increased risk of a poor outcome may enable proactive interventions that improve outcomes.Methods and resultsWe used data from a longitudinal HF registry, CHAMP-HF, to develop a risk prediction tool for poor outcomes over the next 6 months. A poor outcome was defined as death, an HF hospitalization, or a ≥20-point decrease (or decrease below 25) in 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) overall summary score. Among 4546 patients in CHAMP-HF, 1066 (23%) experienced a poor outcome within 6 months (1.3% death, 11% HF hospitalization, and 11% change in KCCQ-12). The model demonstrated moderate discrimination (c-index = 0.65) and excellent calibration with observed data. The following variables were associated with a poor outcome: age, race, education, New York Heart Association class, baseline KCCQ-12, atrial fibrillation, coronary disease, diabetes, chronic kidney disease, smoking, prior HF hospitalization, and systolic blood pressure. We also created a simplified model with a 0-10 score using six variables (New York Heart Association class, KCCQ-12, coronary disease, chronic kidney disease, prior HF hospitalization, and systolic blood pressure) with similar discrimination (c-index = 0.63). Patients scoring 0-3 were considered low risk (event rate 40%).ConclusionsThe PROMPT-HF risk model can identify outpatients with HFrEF at increased risk of poor outcomes, including clinical events and health status deterioration. With further validation, this model may help inform therapeutic decision making.

Published
2022

20. Design of the healthcare worker exposure response and outcomes (HERO) research platform

Author

Friedland, Anne, Hernandez, Adrian F, Anstrom, Kevin J, Chen-Lim, Mei Lin, Cohen, Lauren W, Currier, Judith S, Forrest, Christopher B, Fraser, Ryan, Fraulo, Elizabeth, George, Anoop, Handberg, Eileen, Jackman, Jennifer, Koellhoffer, Jayne, Lawrence, Daryl, Leverty, Renee, McAdams, Patty, McCourt, Brian, Mickley, Brenda, Naqvi, Syed Hasan, O'Brien, Emily C, Olson, Rachel, Prater, Clyde, Rothman, Russell L, Shenkman, Elizabeth, Shostak, Jack, Turner, Kisha Batey, Webb, Laura, Woods, Chris, Naggie, Susanna, and Program, on behalf of the HERO Research

Subjects
Clinical Trials and Supportive Activities, Infectious Diseases, Lung, Prevention, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, COVID-19, Health Personnel, Humans, Quality of Life, SARS-CoV-2, Treatment Outcome, Healthcare workers, Registry, Study platform, Hydroxychloroquine, Pragmatic trial, HERO Research Program, Medical and Health Sciences, General Clinical Medicine, Public Health
Abstract

BackgroundThe SARS CoV-2 virus has caused one of the deadliest pandemics in recent history, resulting in over 170 million deaths and global economic disruption. There remains an urgent need for clinical trials to test therapies for treatment and prevention.DesignAn online research platform was created to support a registry community of healthcare workers (HCWs) to understand their experiences and conduct clinical studies to address their concerns. The first study, HERO-HCQ, was a double-blind, multicenter, randomized, pragmatic trial to evaluate the superiority of hydroxychloroquine (HCQ) vs placebo for pre-exposure prophylaxis (PrEP) of COVID-19 clinical infection in HCWs. Secondary objectives were to assess the efficacy of HCQ in preventing viral shedding of COVID-19 among HCWs and to assess the safety and tolerability of HCQ.MethodsHCWs joined the Registry and were pre-screened for trial interest and eligibility. Trial participants were randomized 1:1 to receive HCQ or placebo. On-site baseline assessment included a COVID-19 nasopharyngeal PCR and blood serology test. Weekly follow-up was done via an online portal and included screening for symptoms of COVID-19, self-reported testing, adverse events, and quality of life assessments. The on-site visit was repeated at Day 30.DiscussionThe HERO research platform offers an approach to rapidly engage, screen, invite and enroll into clinical studies using a novel participant-facing online portal interface and remote data collection, enabling limited onsite procedures for conduct of a pragmatic clinical trial. This platform may be an example for future clinical trials of common conditions to enable more rapid evidence generation.

Published
2021

21. Patterns of antidepressant therapy and clinical outcomes among ischaemic stroke survivors

Author

Etherton, Mark R, Shah, Shreyansh, Haolin, Xu, Xian, Ying, Maisch, Lesley, Hannah, Deidre, Lindholm, Brianna, Lytle, Barbara, Thomas, Laine, Smith, Eric E, Fonarow, Gregg C, Schwamm, Lee H, Bhatt, Deepak L, Hernandez, Adrian F, and O'Brien, Emily C

Subjects
Biomedical and Clinical Sciences, Biological Psychology, Clinical Sciences, Health Sciences, Psychology, Clinical Research, Mental Health, Depression, Aging, Stroke, Brain Disorders, Neurosciences, 7.1 Individual care needs, Management of diseases and conditions, Good Health and Well Being, Aftercare, Aged, Antidepressive Agents, Brain Ischemia, Humans, Ischemic Stroke, Medicare, Patient Discharge, Survivors, United States, stroke
Abstract

Background and purposeDepression is common after stroke and is often treated with antidepressant medications (AD). ADs have also been hypothesised to improve stroke recovery, although recent randomised trials were neutral. We investigated the patterns of in-hospital AD initiation after ischaemic stroke and association with clinical and readmission outcomes.MethodsAll Medicare fee-for-service beneficiaries aged 65 or older hospitalised for ischaemic stroke in participating Get With The Guidelines-Stroke hospitals between April and December 2014 were eligible for this analysis. Outcome measures included days alive and not in a healthcare institution (home time), all-cause mortality and readmission within 1-year postdischarge. Propensity score (PS)-adjusted logistic regression models were used to evaluate the associations between AD use and each outcome measure. We also compared outcomes in patients prescribed selective serotonin reuptake inhibitors (SSRIs) AD versus those prescribed non-SSRI ADs.ResultsOf 21 805 AD naïve patients included in this analysis, 1835 (8.4%) were started on an AD at discharge. Patients started on an AD had higher rates of depression and prior ischaemic stroke, presented with higher admission National Institutes of Health Stroke Scale score and were less likely to be discharged home. Similarly, patients started on an SSRI had lower rates of discharge to home. Adjusting for stroke severity, patients started on an AD had worse all-cause mortality, all-cause readmission, major adverse cardiac events, readmission for depression and decreased home-time. However, AD use was also associated with an increased risk for the sepsis, a falsification endpoint, suggesting the presence of residual confounding.ConclusionsPatients with ischaemic stroke initiated on AD therapy are at increased risk of poor clinical outcomes and readmission even after PS adjustment, suggesting that poststroke depression requiring medication is a poor prognostic sign. Further research is needed to explore the reasons why depression is associated with worse outcome, and whether AD treatment modifies this risk or not.

Published
2021

22. Effects of Dapagliflozin in Patients in Asia: A Post Hoc Subgroup Analysis From the DELIVER Trial

Author

Wang, Xiaowen, Lam, Carolyn S.P., Vaduganathan, Muthiah, Kondo, Toru, Yang, Mingming, Han, Yaling, Pham, Vinh Nguyen, Chiang, Chern-En, Kitakaze, Masafumi, Miao, Zi Michael, Jhund, Pardeep S., Desai, Akshay S., Inzucchi, Silvio E., de Boer, Rudolf A., Martinez, Felipe A., Kosiborod, Mikhail N., Hernandez, Adrian F., Claggett, Brian, Langkilde, Anna Maria, McMurray, John J.V., and Solomon, Scott D.

Published
2024
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23. Comparing Analytical Methods for Composite End Points in Clinical Trials: Insights from the Vericiguat Global Study in Subjects with Heart Failure With Reduced Ejection Fraction Trial

Author

WESTERHOUT, CYNTHIA M., RATHWELL, SARAH, ANSTROM, KEVIN J., HERNANDEZ, ADRIAN F., PONIKOWSKI, PIOTR, EZEKOWITZ, JUSTIN A., VOORS, ADRIAAN A., FELKER, G. MICHAEL, BAKAL, JEFFREY A., BLAUSTEIN, ROBERT O., NKULIKIYINKA, RICHARD, O'CONNOR, CHRISTOPHER M., and ARMSTRONG, PAUL W.

Published
2024
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26. Transmethylamine‐N‐Oxide Is Associated With Diffuse Cardiac Fibrosis in People Living With HIV

Author

Colaco, Nalini A, Wang, Teresa S, Ma, Yifei, Scherzer, Rebecca, Ilkayeva, Olga R, Desvigne‐Nickens, Patrice, Braunwald, Eugene, Hernandez, Adrian F, Butler, Javed, Shah, Svati H, Shah, Sanjiv J, and Hsue, Priscilla Y

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, HIV/AIDS, Biomedical Imaging, Heart Disease, Heart Disease - Coronary Heart Disease, Nutrition, Cardiovascular, Prevention, 2.1 Biological and endogenous factors, Aetiology, Good Health and Well Being, Aged, Anti-HIV Agents, Bacteria, Biomarkers, Cardiomyopathies, Cross-Sectional Studies, Female, Fibrosis, Gastrointestinal Microbiome, HIV Infections, HIV Long-Term Survivors, Humans, Male, Methylamines, Middle Aged, Myocardium, Predictive Value of Tests, Risk Assessment, Risk Factors, United States, diastolic dysfunction, HIV, myocardial fibrosis, transmethylamine-N-oxide, transmethylamine‐N‐oxide, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

Background People living with HIV are at increased risk of developing diastolic dysfunction, heart failure, and sudden cardiac death, all of which have been characterized by higher levels of myocardial fibrosis. Transmethylamine-N-oxide (TMAO), a dietary gut metabolite, is linked to the development of myocardial fibrosis in animal models. However, it is unclear whether TMAO plays a role in the development of myocardial fibrosis in people living with HIV. Methods and Results The study population consisted of participants enrolled in the multisite cross-sectional study called CHART-HIV (Characterizing Heart Function on Anti-Retroviral Therapy). Participants underwent echocardiography, cardiac magnetic resonance imaging, biomarker analysis, and targeted assessment of gut-related circulating metabolites; diastolic dysfunction was determined by study-specific criteria. Multivariable linear regression models were performed to examine the relationship of gut-related metabolites with serum and imaging measures of myocardial fibrosis. Models were adjusted for traditional cardiovascular, inflammatory, and HIV-related risk factors. Diastolic dysfunction was present in 94 of 195 individuals (48%) in CHART-HIV; this cohort demonstrated higher prevalence of hypertension, hyperlipidemia, and chronic kidney disease as well as higher plasma levels of both TMAO and choline. TMAO levels were associated with parameters reflecting increased left ventricular filling pressures and with a marker of the innate immune system. TMAO levels correlated with diffuse myocardial fibrosis (R=0.35; P

Published
2021

27. Clinical Effectiveness of Sacubitril/Valsartan Among Patients Hospitalized for Heart Failure With Reduced Ejection Fraction

Author

Greene, Stephen J, Choi, Sujung, Lippmann, Steven J, Mentz, Robert J, Greiner, Melissa A, Hardy, N Chantelle, Hammill, Bradley G, Luo, Nancy, Samsky, Marc D, Heidenreich, Paul A, Laskey, Warren K, Yancy, Clyde W, Peterson, Pamela N, Curtis, Lesley H, Hernandez, Adrian F, Fonarow, Gregg C, and O'Brien, Emily C

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Heart Disease, Cardiovascular, Aging, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Aged, Aged, 80 and over, Aminobutyrates, Angiotensin II Type 1 Receptor Blockers, Biphenyl Compounds, Drug Combinations, Female, Heart Failure, Hospitalization, Humans, Male, Medicare, Neprilysin, Patient Discharge, Protease Inhibitors, Registries, Risk Assessment, Risk Factors, Stroke Volume, Time Factors, Treatment Outcome, United States, Valsartan, Ventricular Function, Left, heart failure, reduced ejection fraction, registry, sacubitril, valsartan, sacubitril/valsartan, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

Background Sacubitril/Valsartan has been highly efficacious in randomized trials of heart failure with reduced ejection fraction (HFrEF). However, the effectiveness of sacubitril/valsartan in older patients hospitalized for HFrEF in real-world US practice is unclear. Methods and Results This study included Medicare beneficiaries age ≥65 years who were hospitalized for HFrEF ≤40% in the Get With The Guidelines-Heart Failure registry between October 2015 and December 2018, and eligible for sacubitril/valsartan. Associations between discharge prescription of sacubitril/valsartan and clinical outcomes were assessed after inverse probability of treatment weighting and adjustment for other HFrEF medications. Overall, 1551 (10.9%) patients were discharged on sacubitril/valsartan. Of those not prescribed sacubitril/valsartan, 7857 (62.0%) were prescribed an angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker. Over 12-month follow-up, compared with a discharge prescription of angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker, sacubitril/valsartan was independently associated with lower all-cause mortality (adjusted hazard ratio [HR], 0.82; 95% CI, 0.72-0.94; P=0.004) but not all-cause hospitalization (adjusted HR, 0.97; 95% CI, 0.89-1.07; P=0.55) or heart failure hospitalization (adjusted HR, 1.04; 95% CI, 0.91-1.18; P=0.59). Patients prescribed sacubitril/valsartan versus those without a prescription had lower risk of all-cause mortality (adjusted HR, 0.69; 95% CI, 0.60-0.79; P

Published
2021

28. Association between sacubitril/valsartan initiation and real‐world health status trajectories over 18 months in heart failure with reduced ejection fraction

Author

Thomas, Merrill, Khariton, Yevgeniy, Fonarow, Gregg C, Arnold, Suzanne V, Hill, Larry, Nassif, Michael E, Chan, Paul S, Butler, Javed, Thomas, Laine, DeVore, Adam D, Hernandez, Adrian F, Albert, Nancy M, Patterson, J Herbert, Williams, Fredonia B, and Spertus, John A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Heart Disease, Cardiovascular, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Aminobutyrates, Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Biphenyl Compounds, Drug Combinations, Health Status, Heart Failure, Humans, Quality of Life, Stroke Volume, Valsartan, Angiotensin-neprilysin inhibitor, Health status, Heart failure reduced ejection fraction, Quality of life, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

AimsImproving the health status (symptoms, function, and quality of life) of patients with heart failure with reduced ejection fraction (HFrEF) is a primary treatment goal. Angiotensin receptor neprilysin inhibitors (ARNI) improve short-term health status in clinical practice, but the sustainability of these improvements is unknown.Methods and resultsIn CHAMP-HF, a multicentre observational study of outpatients with HFrEF, patients initiated on ARNI were propensity score matched 1:2 to patients not using ARNI with Cox regression modelling time to ARNI initiation, adjusted for sociodemographic and clinical variables, medical history, medications, and baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. Repeated measures models for the overall KCCQ score and each domain compared the health status trajectories of patients initiated on ARNI vs. not. Among 3930 participants, 746 (19.0%) began ARNI, of whom 576 were matched to 1152 non-ARNI patients. Prior to matching, participants initiated on ARNI were younger, non-Hispanic, had lower EFs, more commonly had a history of ventricular arrhythmia, were less likely to be taking an ACEI/ARB, and more likely to be treated with beta-blockers and mineralocorticoid receptor antagonists. There were no differences after matching. In the matched cohort, participants initiated on ARNI experienced improved health status by 3 months that persisted through 12 months [KCCQ Overall Summary Score (OSS) = 73.4 vs. 70.8; P

Published
2021

29. Correction: Data Sharing Goals for Nonprofit Funders of Clinical Trials.

Author

Coetzee, Timothy, Ball, Mad Price, Boutin, Marc, Bronson, Abby, Dexter, David T, English, Rebecca A, Furlong, Patricia, Goodman, Andrew D, Grossman, Cynthia, Hernandez, Adrian F, Hinners, Jennifer E, Hudson, Lynn, Kennedy, Annie, Marchisotto, Mary Jane, Matrisian, Lynn, Myers, Elizabeth, Nowell, W Benjamin, Nosek, Brian A, Sherer, Todd, Shore, Carolyn, Sim, Ida, Smolensky, Luba, Williams, Christopher, Wood, Julie, and Terry, Sharon F

Abstract

[This corrects the article DOI: 10.2196/23011.].

Published
2021

31. Baseline characteristics of patients in the randomized study to investigate the efficacy and safety of ferric carboxymaltose as treatment for heart failure with iron deficiency: HEART-FID trial

Author

Harrington, Josephine, Mentz, Robert J., Rockhold, Frank W., Garg, Jyotsna, Butler, Javed, De Pasquale, Carmine G., Ezekowitz, Justin A., Lewis, Gregory D., O'Meara, Eileen, Ponikowski, Piotr, Troughton, Richard W., Wong, Yee Weng, Adamczyk, Robert, Blackman, Nicole, and Hernandez, Adrian F.

Published
2023
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32. Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease

Author

Jones, W Schuyler, Mulder, Hillary, Wruck, Lisa M, Pencina, Michael J, Kripalani, Sunil, Muñoz, Daniel, Crenshaw, David L, Effron, Mark B, Re, Richard N, Gupta, Kamal, Anderson, R David, Pepine, Carl J, Handberg, Eileen M, Manning, Brittney R, Jain, Sandeep K, Girotra, Saket, Riley, Danielle, DeWalt, Darren A, Whittle, Jeff, Goldberg, Ythan H, Roger, Veronique L, Hess, Rachel, Benziger, Catherine P, Farrehi, Peter, Zhou, Li, Ford, Daniel E, Haynes, Kevin, VanWormer, Jeffrey J, Knowlton, Kirk U, Kraschnewski, Jennifer L, Polonsky, Tamar S, Fintel, Dan J, Ahmad, Faraz S, McClay, James C, Campbell, James R, Bell, Douglas S, Fonarow, Gregg C, Bradley, Steven M, Paranjape, Anuradha, Roe, Matthew T, Robertson, Holly R, Curtis, Lesley H, Sharlow, Amber G, Berdan, Lisa G, Hammill, Bradley G, Harris, Debra F, Qualls, Laura G, Marquis-Gravel, Guillaume, Modrow, Madelaine F, Marcus, Gregory M, Carton, Thomas W, Nauman, Elizabeth, Waitman, Lemuel R, Kho, Abel N, Shenkman, Elizabeth A, McTigue, Kathleen M, Kaushal, Rainu, Masoudi, Frederick A, Antman, Elliott M, Davidson, Desiree R, Edgley, Kevin, Merritt, James G, Brown, Linda S, Zemon, Doris N, McCormick, Thomas E, Alikhaani, Jacqueline D, Gregoire, Kenneth C, Rothman, Russell L, Harrington, Robert A, and Hernandez, Adrian F

Subjects
Clinical Trials and Supportive Activities, Heart Disease - Coronary Heart Disease, Cardiovascular, Patient Safety, Comparative Effectiveness Research, Clinical Research, Heart Disease, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Aged, Aspirin, Atherosclerosis, Cardiovascular Diseases, Female, Hemorrhage, Hospitalization, Humans, Male, Medication Adherence, Middle Aged, Myocardial Infarction, Platelet Aggregation Inhibitors, Secondary Prevention, Stroke, ADAPTABLE Team, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy.MethodsUsing an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis.ResultsA total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]).ConclusionsIn this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).

Published
2021

35. Dapagliflozin in Patients With Heart Failure and Deterioration in Renal Function

Author

Chatur, Safia, Vaduganathan, Muthiah, Claggett, Brian L., Mc Causland, Finnian R., Desai, Akshay S., Jhund, Pardeep S., de Boer, Rudolf A., Hernandez, Adrian F., Inzucchi, Silvio E., Kosiborod, Mikhail N., Lam, Carolyn S.P., Martinez, Felipe A., Shah, Sanjiv J., Sabatine, Marc S., Kober, Lars, Ponikowski, Piotr, Merkely, Bela, Petersson, Magnus, Langkilde, Anna Maria, McMurray, John J.V., and Solomon, Scott D.

Published
2023
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36. Cardio-Renal-Metabolic Overlap, Outcomes, and Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction

Author

Ostrominski, John W., Thierer, Jorge, Claggett, Brian L., Miao, Zi Michael, Desai, Akshay S., Jhund, Pardeep S., Kosiborod, Mikhail N., Lam, Carolyn S.P., Inzucchi, Silvio E., Martinez, Felipe A., de Boer, Rudolf A., Hernandez, Adrian F., Shah, Sanjiv J., Petersson, Magnus, Langkilde, Anna Maria, McMurray, John J.V., Solomon, Scott D., and Vaduganathan, Muthiah

Published
2023
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37. 2022 ACC/AHA guideline for the diagnosis and management of aortic disease: A report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines

Author

Isselbacher, Eric M., Preventza, Ourania, Hamilton Black, James, III, Augoustides, John G., Beck, Adam W., Bolen, Michael A., Braverman, Alan C., Bray, Bruce E., Brown-Zimmerman, Maya M., Chen, Edward P., Collins, Tyrone J., DeAnda, Abe, Jr., Fanola, Christina L., Girardi, Leonard N., Hicks, Caitlin W., Hui, Dawn S., Schuyler Jones, William, Kalahasti, Vidyasagar, Kim, Karen M., Milewicz, Dianna M., Oderich, Gustavo S., Ogbechie, Laura, Promes, Susan B., Ross, Elsie Gyang, Schermerhorn, Marc L., Singleton Times, Sabrina, Tseng, Elaine E., Wang, Grace J., Woo, Y. Joseph, Faxon, David P., Upchurch, Gilbert R., Jr, Aday, Aaron W., Azizzadeh, Ali, Boisen, Michael, Hawkins, Beau, Kramer, Christopher M., Luc, Jessica G.Y., MacGillivray, Thomas E., Malaisrie, S. Christopher, Osteen, Kathryn, Patel, Himanshu J., Patel, Parag J., Popescu, Wanda M., Rodriguez, Evelio, Sorber, Rebecca, Tsao, Philip S., Santos Volgman, Annabelle, Beckman, Joshua A., Otto, Catherine M., O'Gara, Patrick T., Armbruster, Anastasia, Birtcher, Kim K., de las Fuentes, Lisa, Deswal, Anita, Dixon, Dave L., Gorenek, Bulent, Haynes, Norrisa, Hernandez, Adrian F., Joglar, José A., Jones, W. Schuyler, Mark, Daniel, Mukherjee, Debabrata, Palaniappan, Latha, Piano, Mariann R., Rab, Tanveer, Spatz, Erica S., and Tamis-Holland, Jacqueline E.

Published
2023
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38. Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction According to Polypharmacy Status

Author

Peikert, Alexander, Goyal, Parag, Vaduganathan, Muthiah, Claggett, Brian L., Kulac, Ian J., Miao, Zi Michael, Vardeny, Orly, Kosiborod, Mikhail N., Desai, Akshay S., Jhund, Pardeep S., Lam, Carolyn S.P., Inzucchi, Silvio E., Martinez, Felipe A., de Boer, Rudolf A., Hernandez, Adrian F., Shah, Sanjiv J., Petersson, Magnus, Langkilde, Anna Maria, McMurray, John J.V., and Solomon, Scott D.

Published
2023
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39. Comparison of the effectiveness and safety of 2 aspirin doses in secondary prevention of cardiovascular outcomes in patients with chronic kidney disease: A subgroup analysis of ADAPTABLE

Author

Gupta, Kamal, Mehta, Harsh, Kim, Hwasoon, Stebbins, Amanda, Wruck, Lisa M., Muñoz, Daniel, Effron, Mark B., Anderson, R. David, Pepine, Carl J., Jain, Sandeep K., Girotra, Saket, DeWalt, Darren A., Whittle, Jeff, Benziger, Catherine P., Farrehi, Peter, Zhou, Li, Knowlton, Kirk U., Polonsky, Tamar S., Bradley, Steven M., Harrington, Robert A., Rothman, Russell L., Jones, W. Schuyler, and Hernandez, Adrian F.

Published
2023
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40. Operational challenges and mitigation measures during the COVID-19 pandemic–Lessons from DELIVER

Author

Bhatt, Ankeet S., Lindholm, Daniel, Nilsson, Ann, Zaozerska, Natalia, Claggett, Brian L., Vaduganathan, Muthiah, Kosiborod, Mikhail N., Lam, Carolyn S.P., Hernandez, Adrian F., Martinez, Felipe A., Inzucchi, Silvio E, Shah, Sanjiv J., de Boer, Rudolf A., Desai, Akshay, Jhund, Pardeep S., Langkilde, Anna Maria, Petersson, Magnus, McMurray, John J.V., and Solomon, Scott D.

Published
2023
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41. Dapagliflozin and Apparent Treatment-Resistant Hypertension in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: The DELIVER Trial

Author

Ostrominski, John W., Vaduganathan, Muthiah, Selvaraj, Senthil, Claggett, Brian L., Miao, Zi Michael, Desai, Akshay S., Jhund, Pardeep S., Kosiborod, Mikhail N., Lam, Carolyn S.P., Inzucchi, Silvio E., Martinez, Felipe A., de Boer, Rudolf A., Hernandez, Adrian F., Shah, Sanjiv J., Petersson, Magnus, Maria Langkilde, Anna, McMurray, John J.V., and Solomon, Scott D.

Published
2023
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43. Author Correction: Dapagliflozin in heart failure with improved ejection fraction: a prespecified analysis of the DELIVER trial

Author

Vardeny, Orly, Fang, James C., Desai, Akshay S., Jhund, Pardeep S., Claggett, Brian, Vaduganathan, Muthiah, de Boer, Rudolf A., Hernandez, Adrian F., Lam, Carolyn S. P., Inzucchi, Silvio E., Martinez, Felipe A., Kosiborod, Mikhail N., DeMets, David, O’Meara, Eileen, Zieroth, Shelley, Comin-Colet, Josep, Drozdz, Jaroslaw, Chiang, Chern-En, Kitakaze, Masafumi, Petersson, Magnus, Lindholm, Daniel, Langkilde, Anna Maria, McMurray, John J. V., and Solomon, Scott D.

Published
2023
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44. Dapagliflozin in heart failure with improved ejection fraction: a prespecified analysis of the DELIVER trial

Author

Vardeny, Orly, Fang, James C., Desai, Akshay S., Jhund, Pardeep S., Claggett, Brian, Vaduganathan, Muthiah, de Boer, Rudolf A., Hernandez, Adrian F., Lam, Carolyn S. P., Inzucchi, Silvio E., Martinez, Felipe A., Kosiborod, Mikhail N., DeMets, David, O’Meara, Eileen, Zieroth, Shelley, Comin-Colet, Josep, Drozdz, Jaroslaw, Chiang, Chern-En, Kitakaze, Masafumi, Petersson, Magnus, Lindholm, Daniel, Langkilde, Anna Maria, McMurray, John J. V., and Solomon, Scott D.

Published
2022
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50. Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC)

Author

Anker, Stefan D, Butler, Javed, Khan, Muhammad Shahzeb, Abraham, William T, Bauersachs, Johann, Bocchi, Edimar, Bozkurt, Biykem, Braunwald, Eugene, Chopra, Vijay K, Cleland, John G, Ezekowitz, Justin, Filippatos, Gerasimos, Friede, Tim, Hernandez, Adrian F, Lam, Carolyn SP, Lindenfeld, JoAnn, McMurray, John JV, Mehra, Mandeep, Metra, Marco, Packer, Milton, Pieske, Burkert, Pocock, Stuart J, Ponikowski, Piotr, Rosano, Giuseppe MC, Teerlink, John R, Tsutsui, Hiroyuki, Van Veldhuisen, Dirk J, Verma, Subodh, Voors, Adriaan A, Wittes, Janet, Zannad, Faiez, Zhang, Jian, Seferovic, Petar, and Coats, Andrew JS

Subjects
Clinical Research, Patient Safety, Clinical Trials and Supportive Activities, Cardiovascular, Heart Disease, Prevention, Good Health and Well Being, Betacoronavirus, COVID-19, Clinical Trials as Topic, Coronavirus Infections, Europe, Heart Failure, Humans, Informed Consent, Pandemics, Patient Selection, Pneumonia, Viral, Research Design, SARS-CoV-2, Heart failure, Clinical trials, Coronavirus, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology
Abstract

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.

Published
2020

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