Search

Your search keyword '"Lindenfeld, Joann"' showing total 1,894 results
Start Over Author "Lindenfeld, Joann"
1,894 results on '"Lindenfeld, Joann"'

2. Proteomic architecture of frailty across the spectrum of cardiovascular disease.

Author

Perry, Andrew, Zhao, Shilin, Gajjar, Priya, Murthy, Venkatesh, Lehallier, Benoit, Miller, Patricia, Nair, Sangeeta, Neill, Colin, Carr, J, Fearon, William, Kapadia, Samir, Kumbhani, Dharam, Gillam, Linda, Lindenfeld, JoAnn, Farrell, Laurie, Marron, Megan, Tian, Qu, Newman, Anne, Murabito, Joanne, Gerszten, Robert, Nayor, Matthew, Lindman, Brian, Shah, Ravi, and Elmariah, Sammy

Subjects
cardiovascular disease, frailty, proteomics
Abstract

While frailty is a prominent risk factor in an aging population, the underlying biology of frailty is incompletely described. Here, we integrate 979 circulating proteins across a wide range of physiologies with 12 measures of frailty in a prospective discovery cohort of 809 individuals with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation. Our aim was to characterize the proteomic architecture of frailty in a highly susceptible population and study its relation to clinical outcome and systems-wide phenotypes to define potential novel, clinically relevant frailty biology. Proteomic signatures (specifically of physical function) were related to post-intervention outcome in AS, specifying pathways of innate immunity, cell growth/senescence, fibrosis/metabolism, and a host of proteins not widely described in human aging. In published cohorts, the frailty proteome displayed heterogeneous trajectories across age (20-100 years, age only explaining a small fraction of variance) and were associated with cardiac and non-cardiac phenotypes and outcomes across two broad validation cohorts (N > 35,000) over ≈2-3 decades. These findings suggest the importance of precision biomarkers of underlying multi-organ health status in age-related morbidity and frailty.

Published
2023

3. Clonal hematopoiesis of indeterminate potential and outcomes after heart transplantation: A multicenter study.

Author

Amancherla, Kaushik, Schlendorf, Kelly, Vlasschaert, Caitlyn, Lowery, Brandon, Wells, Quinn, See, Sarah, Zorn, Emmanuel, Colombo, Paolo, Reilly, Muredach, Lindenfeld, JoAnn, Uriel, Nir, Freedman, Jane, Shah, Ravi, Moslehi, Javid, Bick, Alexander, and Clerkin, Kevin

Subjects
CHIP, cardiac allograft vasculopathy, clonal hematopoiesis of indeterminate potential, heart transplant, transplant genomics, Humans, Clonal Hematopoiesis, Heart Transplantation, Heart Diseases, Vascular Diseases, Risk Factors, Allografts
Abstract

Cardiac allograft vasculopathy (CAV) is a leading cause of late graft failure and mortality after heart transplantation (HT). Sharing some features with atherosclerosis, CAV results in diffuse narrowing of the epicardial coronaries and microvasculature, with consequent graft ischemia. Recently, clonal hematopoiesis of indeterminate potential (CHIP) has emerged as a risk factor for cardiovascular disease and mortality. We aimed to investigate the relationship between CHIP and posttransplant outcomes, including CAV. We analyzed 479 HT recipients with stored DNA samples at 2 high-volume transplant centers, Vanderbilt University Medical Center and Columbia University Irving Medical Center. We explored the association between the presence of CHIP mutations with CAV and mortality after HT. In this case-control analysis, carriers of CHIP mutations were not at increased risk of CAV or mortality after HT. In a large multicenter genomics study of the heart transplant population, the presence of CHIP mutations was not associated with an increased risk of CAV or posttransplant mortality.

Published
2023

5. Validity of Patient-Reported Outcomes Measurement Information System Physical, Mental, and Social Health Measures After Left Ventricular Assist Device Implantation and Implications for Patient Care.

Author

Hahn, Elizabeth A, Walsh, Mary N, Allen, Larry A, Lee, Christopher S, Denfeld, Quin E, Teuteberg, Jeffrey J, Beiser, David G, McIlvennan, Colleen K, Lindenfeld, JoAnn, Klein, Liviu, Adler, Eric D, Stehlik, Josef, Ruo, Bernice, Bedjeti, Katy, Cummings, Peter D, Vela, Alyssa M, and Grady, Kathleen L

Subjects
Humans, Patient Care, Heart-Assist Devices, Quality of Life, Information Systems, Adult, Middle Aged, Female, Male, Patient Reported Outcome Measures, adult, fatigue, female, heart failure, humans, patient reported outcome measures, Behavioral and Social Science, Cardiovascular, Heart Disease, Mental Health, Clinical Research, Brain Disorders, Rehabilitation, Bioengineering, Mental health, Good Health and Well Being, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

BackgroundA better understanding is needed of the burdens and benefits of left ventricular assist device (LVAD) implantation on patients' physical, mental, and social well-being. The purpose of this report was to evaluate the validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures for LVAD patients and to estimate clinically important score differences likely to have implications for patient treatment or care.MethodsAdults from 12 sites across all US geographic regions completed PROMIS measures ≥3 months post-LVAD implantation. Other patient-reported outcomes (eg, Kansas City Cardiomyopathy Questionnaire-12 item), clinician ratings, performance tests, and clinical adverse events were used as validity indicators. Criterion and construct validity and clinically important differences were estimated with Pearson correlations, ANOVA methods, and Cohen d effect sizes.ResultsParticipants' (n=648) mean age was 58 years, and the majority were men (78%), non-Hispanic White people (68%), with dilated cardiomyopathy (55%), long-term implantation strategy (57%), and New York Heart Association classes I and II (54%). Most correlations between validity indicators and PROMIS measures were medium to large (≥0.3; p

Published
2023

6. Single-Nuclear RNA Sequencing of Endomyocardial Biopsies Identifies Persistence of Donor-Recipient Chimerism With Distinct Signatures in Severe Cardiac Allograft Vasculopathy

Author

Amancherla, Kaushik, Qin, Juan, Hulke, Michelle L, Pfeiffer, Ryan D, Agrawal, Vineet, Sheng, Quanhu, Xu, Yaomin, Schlendorf, Kelly H, Lindenfeld, JoAnn, Shah, Ravi V, Freedman, Jane E, Tucker, Nathan R, and Moslehi, Javid

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Humans, Chimerism, Heart Failure, Heart Transplantation, Biopsy, Allografts, Sequence Analysis, RNA, Graft Rejection, allografts, biopsy, fibroblasts, genomics, myocardium, Biochemistry and Cell Biology, Cardiorespiratory Medicine and Haematology, Medical Physiology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Medical physiology
Published
2023

7. Pulmonary Vein Systolic Flow Reversal and Outcomes in Patients From the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) Trial

Author

Bohra, Chandrashekar, Asch, Federico M., Lerakis, Stamatios, Little, Stephen H., Redfors, Björn, Zhou, Zhipeng, Li, Yanru, Weissman, Neil J., Grayburn, Paul A., Kar, Saibal, Lim, D. Scott, Abraham, William T., Lindenfeld, JoAnn, Mack, Michael J., Bax, Jeroen J., and Stone, Gregg W.

Published
2024
Full Text
View/download PDF

10. Efficient measurement of multiple ventricular assist device patient-reported outcomes: Creation of a 20-item profile from the MCS A-QOL study

Author

Grady, Kathleen L., Kallen, Michael A., Cella, David, Allen, Larry A., Lindenfeld, JoAnn, McIlvennan, Colleen K., Beiser, David G., Walsh, Mary Norine, Denfeld, Quin E., Lee, Christopher S., Ruo, Bernice, Murks, Catherine, Stehlik, Josef, Kirklin, James K., Teuteberg, Jeffrey, Adler, Eric, Kiernan, Michael, Rich, Jonathan, Bedjeti, Katy, and Hahn, Elizabeth A.

Published
2024
Full Text
View/download PDF

14. Changes in Left Ventricular Function and Outcomes After Trancatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation

Author

Lerakis, Stamatios, Kini, Annapoorna S., Giustino, Gennaro, Anastasius, Malcolm, Asch, Federico M., Weissman, Neil J., Grayburn, Paul A., Kar, Saibal, Lim, D. Scott, Mishell, Jacob M., Whisenant, Brian K., Rinaldi, Michael J., Kapadia, Samir R., Rajagopal, Vivek, Sarembock, Ian J., Brieke, Andreas, Tang, Gilbert H.L., Li, Yanru, Alu, Maria C., Lindenfeld, JoAnn, Abraham, William T., Sharma, Samin K., Mack, Michael J., and Stone, Gregg W.

Published
2024
Full Text
View/download PDF

15. Early Assessment of Cardiac Allograft Vasculopathy Risk Among Recipients of Hepatitis C Virus-infected Donors in the Current Era

Author

AMANCHERLA, KAUSHIK, FEURER, IRENE D., REGA, SCOTT A., CLUCKEY, ANDREW, SALIH, MOHAMED, DAVIS, JONATHAN, PEDROTTY, DAWN, OOI, HENRY, RALI, ANIKET S., SIDDIQI, HASAN K., MENACHEM, JONATHAN, BRINKLEY, DOUGLAS M., PUNNOOSE, LYNN, SACKS, SUZANNE B., ZALAWADIYA, SANDIP K., WIGGER, MARK, BALSARA, KEKI, TRAHANAS, JOHN, MCMASTER, WILLIAM G., HOFFMAN, JORDAN, PASRIJA, CHETAN, LINDENFELD, JOANN, SHAH, ASHISH S., and SCHLENDORF, KELLY H.

Published
2024
Full Text
View/download PDF

16. 2024 ACC Expert Consensus Decision Pathway for Treatment of Heart Failure With Reduced Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee

Author

Maddox, Thomas M., Januzzi, James L., Jr., Allen, Larry A., Breathett, Khadijah, Brouse, Sara, Butler, Javed, Davis, Leslie L., Fonarow, Gregg C., Ibrahim, Nasrien E., Lindenfeld, JoAnn, Masoudi, Frederick A., Motiwala, Shweta R., Oliveros, Estefania, Walsh, Mary Norine, Wasserman, Alan, Yancy, Clyde W., and Youmans, Quentin R.

Published
2024
Full Text
View/download PDF

19. Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials JACC Review Topic of the Week

Author

Fiuzat, Mona, Hamo, Carine E, Butler, Javed, Abraham, William T, DeFilippis, Ersilia M, Fonarow, Gregg C, Lindenfeld, Joann, Mentz, Robert J, Psotka, Mitchell A, Solomon, Scott D, Teerlink, John R, Vaduganathan, Muthiah, Vardeny, Orly, McMurray, John JV, and O’Connor, Christopher M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Heart Disease, Cardiovascular, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Cardiovascular Agents, Clinical Trials as Topic, Heart Failure, Humans, Periodicals as Topic, Stroke Volume, clinical trials, device therapy, drug therapy, FDA, guideline directed, medical therapy, heart failure, HFrEF, medication, guideline directed medical therapy, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

With the current landscape of approved therapies for heart failure (HF), there is a need to determine the role of a standard background therapy against which novel therapies are studied. The Heart Failure Collaboratory convened a multistakeholder group of clinical investigators, clinicians, patients, government representatives including U.S. Food and Drug Administration and National Institutes of Health participants, payers, and industry in March 2021 to discuss whether standardization of background drug therapy is necessary in clinical trials in patients with HF. The current paper summarizes the discussion and provides potential conceptual approaches, with a focus on therapies indicated for HF with reduced ejection fraction.

Published
2022

21. Rejection in the setting of combined Heart and Liver Transplantation

Author

Nandkeolyar, Shuktika, Gupta, Tripti, Brinkley, D. Marshall, Alexopoulos, Sophoclis, Firsich, Emily, Fossey, Sally Anne, Fowler, Rachel, Frischhertz, Benjamin, Harrison, Kimberly, Lindenfeld, JoAnn, Montenovo, Martin, Pedrotty, Dawn, Punnoose, Lynn, Rali, Aniket, Shingina, Alexandra, Schlendorf, Kelly, Siddiqi, Hasan, Shah, Ashish, Zalawadiya, Sandip, Wigger, Mark, and Menachem, Jonathan N.

Published
2024
Full Text
View/download PDF

23. Cross-Validation of Risk Scores for Patients Undergoing Transcatheter Edge-to-Edge Repair for Mitral Regurgitation

Author

Estévez-Loureiro, Rodrigo, Shah, Neeraj, Raposeiras-Roubin, Sergio, Kotinkaduwa, Lak N., Madhavan, Mahesh V., Gray, William A., Lindenfeld, JoAnn, Adamo, Marianna, Abraham, William T., Freixa, Xavier, Grayburn, Paul A., Arzamendi, Dabit, Kar, Saibal, Benito-González, Tomas, Lim, D. Scott, Montefusco, Antonio, Redfors, Björn, Pascual, Isaac, Nombela-Franco, Luis, Rodés-Cabau, Josep, Shuvy, Mony, Moñivas, Vanessa, Godino, Cosmo, Mack, Michael J., Bedogni, Francesco, and Stone, Gregg W.

Published
2024
Full Text
View/download PDF

26. Novel measures to assess ventricular assist device patient-reported outcomes: Findings from the MCS A-QOL study

Author

Grady, Kathleen L., Kallen, Michael A., Beiser, David G., Lindenfeld, JoAnn, Teuteberg, Jeffrey, Allen, Larry A., McIlvennan, Colleen K., Rich, Jonathan, Yancy, Clyde, Lee, Christopher S., Denfeld, Quin E., Kiernan, Michael, Walsh, Mary Norine, Adler, Eric, Ruo, Bernice, Stehlik, Josef, Kirklin, James K., Bedjeti, Katy, Cella, Dave, and Hahn, Elizabeth A.

Published
2024
Full Text
View/download PDF

27. In-Hospital Initiation of Sodium-Glucose Cotransporter-2 Inhibitors for Heart Failure With Reduced Ejection Fraction

Author

Rao, Vishal N, Murray, Evan, Butler, Javed, Cooper, Lauren B, Cox, Zachary L, Fiuzat, Mona, Green, Jennifer B, Lindenfeld, JoAnn, McGuire, Darren K, Nassif, Michael E, O'Brien, Cara, Pagidipati, Neha, Sharma, Kavita, Vaduganathan, Muthiah, Vardeny, Orly, Fonarow, Gregg C, Mentz, Robert J, and Greene, Stephen J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Cardiovascular, Heart Disease, Clinical Research, Patient Safety, 5.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Development of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Diabetes Mellitus, Type 2, Heart Failure, Hospitalization, Humans, Hypoglycemic Agents, Patient Discharge, Patient Readmission, Patient-Centered Care, Practice Guidelines as Topic, Randomized Controlled Trials as Topic, Risk, Sodium-Glucose Transporter 2, Sodium-Glucose Transporter 2 Inhibitors, Stroke Volume, Ventricular Dysfunction, Left, &nbsp, guideline-directed medical therapy, heart failure, in-hospital prescribing, medical therapy, sodium-glucose cotransporter-2 inhibitors, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

Sodium-glucose cotransporter-2 inhibitor therapy is well suited for initiation during the heart failure hospitalization, owing to clinical benefits that accrue rapidly within days to weeks, a strong safety and tolerability profile, minimal to no effects on blood pressure, and no excess risk of adverse kidney events. There is no evidence to suggest that deferring initiation to the outpatient setting accomplishes anything beneficial. Instead, there is compelling evidence that deferring in-hospital initiation exposes patients to excess risk of early postdischarge clinical worsening and death. Lessons from other heart failure with reduced ejection fraction therapies highlight that deferring initiation of guideline-recommended medications to the U.S. outpatient setting carries a >75% chance they will not be initiated within the next year. Recognizing that 1 in 4 patients hospitalized for worsening heart failure die or are readmitted within 30 days, clinicians should embrace the in-hospital period as an optimal time to initiate sodium-glucose cotransporter-2 inhibitor therapy and treat this population with the urgency it deserves.

Published
2021

28. Tricuspid Valve Academic Research Consortium Definitions for Tricuspid Regurgitation and Trial Endpoints

Author

Arnold, Suzanne, Bapat, Vinayak, Berry, Natalia, Blanke, Philipp, Burkhoff, Daniel, Coylewright, Megan, Duggal, Neal, Galper, Benjamin, George, Isaac, Guerrero, Mayra, Hamid, Nadira, Jagadeesan, Vikrant, Kodali, Susheel, Krucoff, Mitch, Lang, Roberto, Madhavan, Mahesh, McLaughin, Vallerie, Mehran, Roxana, Philippon, Francois, Sethi, Sanjum S., Simonato, Matheus, Smith, Robert, Sodhi, Nishtha, Spertus, John, Stocker, Thomas J., Stone, Gregg, Hahn, Rebecca T., Lawlor, Matthew K., Davidson, Charles J., Badhwar, Vinay, Sannino, Anna, Spitzer, Ernest, Lurz, Philipp, Lindman, Brian R., Topilsky, Yan, Baron, Suzanne J., Chadderdon, Scott, Khalique, Omar K., Tang, Gilbert H.L., Taramasso, Maurizio, Grayburn, Paul A., Badano, Luigi, Leipsic, Jonathon, Lindenfeld, JoAnn, Windecker, Stephan, Vemulapalli, Sreekanth, Redfors, Bjorn, Alu, Maria C., Cohen, David J., Rodés-Cabau, Josep, Ailawadi, Gorav, Mack, Michael, Ben-Yehuda, Ori, Leon, Martin B., and Hausleiter, Jörg

Published
2023
Full Text
View/download PDF

29. Randomized controlled trial of urinE chemiStry guided aCute heArt faiLure treATmEnt (ESCALATE): Rationale and design

Author

Cox, Zachary L., Siddiqi, Hasan K., Stevenson, Lynne W., Bales, Brian, Han, Jin H., Hart, Kimberly, Imhoff, Brant, Ivey-Miranda, Juan B., Jenkins, Cathy A., Lindenfeld, JoAnn, Shotwell, Matthew S., Miller, Karen F., Ooi, Henry, Rao, Veena S., Schlendorf, Kelly, Self, Wesley H., Siew, Edward D., Storrow, Alan, Walsh, Ryan, Wrenn, Jesse O., Testani, Jeffrey M., and Collins, Sean P.

Published
2023
Full Text
View/download PDF

30. PROMIS: Physical, Mental and Social Health Outcomes Improve From Before to Early After LVAD Implant: Findings From the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) Study

Author

HAHN, ELIZABETH A., ALLEN, LARRY A., LEE, CHRISTOPHER S., DENFELD, QUIN E., STEHLIK, JOSEF, CELLA, DAVID, LINDENFELD, JOANN, TEUTEBERG, JEFFREY J., MCILVENNAN, COLLEEN K., KIERNAN, MICHAEL S., BEISER, DAVID G., WALSH, MARY N., ADLER, ERIC D., RUO, BERNICE, KIRKLIN, JAMES K., KLEIN, LIVIU, BEDJETI, KATY, CUMMINGS, PETER D., BURNS, JAMES L., VELA, ALYSSA M., and GRADY, KATHLEEN L.

Published
2023
Full Text
View/download PDF

35. Abstract 13362: Proteomic Architecture of Frailty Across the Spectrum of Cardiovascular Disease

Author

Perry, Andrew, Zhao, SHilin, Gajjar, Priya, Murthy, Venkatesh L, Lehallier, Benoit, Miller, Patricia, Nair, Sangeeta, Neill, Colin, Carr, Jeffrey, Fearon, William F, Kapadia, Samir R, Kumbhani, Dharam J, Gillam, Linda D, Lindenfeld, Joann, Farrell, Laurie, Marron, Megan M, Tian, Qu, Newman, Anne, Murabito, Joanne, Gerszten, Robert E, Nayor, Matthew G, Elmariah, Sammy, Lindman, Brian R, and Shah, Ravi V

Published
2023
Full Text
View/download PDF

36. Abstract 12936: Quality of Life Assessments as Inclusion Criteria in Heart Failure Clinical Trials

Author

Dimond, Matthew, Khan, Mohammad S, Fiuzat, Mona, Cleland, John G, Bhatt, Ankeet, Psotka, Mitchell, Anker, Stefan D, Butler, Javed, Felker, Michael, Mark, Daniel B, Carson, Peter E, Abraham, William T, Ahmad, Tariq, Lindenfeld, Joann, Vaduganathan, Muthiah, Whellan, David J, Vardeny, Orly, Solomon, Scott, Lewis, Eldrin F, Filippatos, Gerasimos, and OConnor, Christopher M

Published
2023
Full Text
View/download PDF

43. Representation of Women Authors in International Heart Failure Guidelines and Contemporary Clinical Trials

Author

Reza, Nosheen, Tahhan, Ayman Samman, Mahmud, Nadim, DeFilippis, Ersilia M, Alrohaibani, Alaaeddin, Vaduganathan, Muthiah, Greene, Stephen J, Ho, Annie Hang, Fonarow, Gregg C, Butler, Javed, O’Connor, Christopher, Fiuzat, Mona, Vardeny, Orly, Piña, Ileana L, Lindenfeld, JoAnn, and Jessup, Mariell

Subjects
Biomedical and Clinical Sciences, Medical Physiology, Cardiovascular Medicine and Haematology, Cardiovascular, Heart Disease, Clinical Research, Clinical Trials and Supportive Activities, Gender Equality, Authorship, Cardiology, Europe, Female, Humans, Manuscripts, Medical as Topic, Publishing, United States, Women, clinical trial, guideline, heart failure, publications, women, Biochemistry and Cell Biology, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Medical physiology
Abstract

BackgroundGender disparities in authorship of heart failure (HF) guideline citations and clinical trials have not been examined.MethodsWe identified authors of publications referenced in Class I Recommendations in United States (n=173) and European (n=100) HF guidelines and of publications of all HF trials with >400 participants (n=118) published between 2001 and 2016. Authors' genders were determined, and changes in authorship patterns over time were evaluated with linear regression and nonparametric testing.ResultsThe median proportion of women authors per publication was 20% (interquartile range [IQR], 8%-33%) in United States guidelines, 14% (IQR, 2%-20%) in European guidelines, and 11% (IQR, 4%-20%) in HF trials. The proportion of women authors increased modestly over time in United States and European guidelines' references (β=0.005 and 0.003, respectively, from 1986 to 2016; P0.50). Overall proportions of women as first or last authors in HF trials (16%) did not change significantly over time (P=0.60). North American HF trials had the highest likelihood of having a woman as first or senior author (24%). HF trials with a woman first or senior author were associated with a higher proportion of enrolled female participants (39% versus 26%, P=0.01).ConclusionsIn HF practice guidelines and trials, few women are authors of pivotal publications. Higher number of women authors is associated with higher enrollment of women in HF trials. Barriers to authorship and representation of women in HF guidelines and HF trial leadership need to be addressed.

Published
2020

44. 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

45. Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Author

Butler, Javed, Packer, Milton, Greene, Stephen J, Fiuzat, Mona, Anker, Stefan D, Anstrom, Kevin J, Carson, Peter E, Cooper, Lauren B, Fonarow, Gregg C, Hernandez, Adrian F, Januzzi, James L, Jessup, Mariell, Kalyani, Rita R, Kaul, Sanjay, Kosiborod, Mikhail, Lindenfeld, JoAnn, McGuire, Darren K, Sabatine, Marc S, Solomon, Scott D, Teerlink, John R, Vaduganathan, Muthiah, Yancy, Clyde W, Stockbridge, Norman, and O'Connor, Christopher M

Subjects
Cardiovascular, Clinical Trials and Supportive Activities, Clinical Research, Heart Disease, Heart Disease - Coronary Heart Disease, Diabetes, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Cardiovascular Diseases, Clinical Trials as Topic, Diabetes Mellitus, Type 2, Endpoint Determination, Heart Failure, Humans, Research Report, Sodium-Glucose Transporter 2, Sodium-Glucose Transporter 2 Inhibitors, Treatment Outcome, biomarkers, clinical trial, diabetes mellitus, type 2, heart failure, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

Following regulatory guidance set forth in 2008 by the US Food and Drug Administration for new drugs for type 2 diabetes mellitus, many large randomized, controlled trials have been conducted with the primary goal of assessing the safety of antihyperglycemic medications on the primary end point of major adverse cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Heart failure (HF) was not specifically mentioned in the US Food and Drug Administration guidance and therefore it was not a focus of these studies when planned. Several trials subsequently showed the impact of antihyperglycemic drugs on HF outcomes, which were not originally specified as the primary end point of the trials. The most impressive finding has been the substantial and consistent risk reduction in HF hospitalization seen across 4 trials of sodium glucose cotransporter 2 inhibitors. However, to date, these results have not led to regulatory approval of any of these drugs for a HF indication or a recommendation for use by US HF guidelines. It is therefore important to explore to what extent persuasive treatment effects on nonprimary end points can be used to support regulatory claims and guideline recommendations. This topic was discussed by researchers, clinicians, industry sponsors, regulators, and representatives from professional societies, who convened on the US Food and Drug Administration campus on March 6, 2019. This report summarizes these discussions and the key takeaway messages from this meeting.

Published
2019

47. In vivo fluid dynamics of the Ventura interatrial shunt device in patients with heart failure

Author

Pfeiffer, Michael, primary, Boehmer, John, additional, Gorcsan, John, additional, Eguchi, Shunsuke, additional, Orihara, Yoshiyuki, additional, Perl, Michal Laufer, additional, Eigler, Neal, additional, Abraham, William T., additional, Villota, Julio Nuñez, additional, Lee, Elizabeth, additional, Bayés‐Genís, Antoni, additional, Moravsky, Gil, additional, Kar, Saibal, additional, Zile, Michael R., additional, Holcomb, Richard, additional, Anker, Stefan D., additional, Stone, Gregg W., additional, Rodés‐Cabau, Josep, additional, Lindenfeld, JoAnn, additional, and Bax, Jeroen J., additional

Published
2024
Full Text
View/download PDF

48. Repeat Mitral Valve Interventions After Transcatheter Edge-to-Edge Repair:The COAPT Trial

Author

Shahim, Bahira, primary, Cohen, David J., additional, Asch, Federico M., additional, Bax, Jeroen, additional, George, Isaac, additional, Rück, Andreas, additional, Ben-Yehuda, Ori, additional, Kar, Saibal, additional, Lim, D. Scott, additional, Saxon, John T., additional, Zhou, Zhipeng, additional, Lindenfeld, Joann, additional, Abraham, William T., additional, Mack, Michael J., additional, and Stone, Gregg W., additional

Published
2024
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results