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7. 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

10. 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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11. Standardized Definitions for Evaluation of Acute Decompensated Heart Failure Therapies: HF-ARC Expert Panel Paper

Author

Lala, Anuradha, Hamo, Carine E., Bozkurt, Biykem, Fiuzat, Mona, Blumer, Vanessa, Bukhoff, Daniel, Butler, Javed, Costanzo, Maria Rosa, Felker, G. Michael, Filippatos, Gerasimos, Konstam, Marvin A., McMurray, John J.V., Mentz, Robert J., Metra, Marco, Psotka, Mitchell A., Solomon, Scott D., Teerlink, John, Abraham, William T., and O’Connor, Christopher M.

Published
2024
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15. 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

16. Representativeness of a Heart Failure Trial by Race and Sex Results From ASCEND-HF and GWTG-HF

Author

Greene, Stephen J, DeVore, Adam D, Sheng, Shubin, Fonarow, Gregg C, Butler, Javed, Califf, Robert M, Hernandez, Adrian F, Matsouaka, Roland A, Samman Tahhan, Ayman, Thomas, Kevin L, Vaduganathan, Muthiah, Yancy, Clyde W, Peterson, Eric D, O'Connor, Christopher M, and Mentz, Robert J

Subjects
Heart Disease, Clinical Research, Clinical Trials and Supportive Activities, Cardiovascular, Good Health and Well Being, Black or African American, Aged, Aged, 80 and over, Female, Heart Failure, Humans, Male, Natriuretic Agents, Natriuretic Peptide, Brain, Patient Selection, Randomized Controlled Trials as Topic, Sex Distribution, White People, enrollment, heart failure, race, sex, trial, Cardiorespiratory Medicine and Haematology
Abstract

ObjectivesThis study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex.BackgroundBlack patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear.MethodsThe ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial randomized patients hospitalized for HF to receive nesiritide or placebo from May 2007 to August 2010 and was neutral for clinical endpoints. This analysis compared non-Hispanic white (n = 1,494) and black (n = 1,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e., Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria.ResultsAmong 79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n = 37,883 [77.2%]; black, n = 11,180 [22.8%]). Women represented 35% and 49% of the ASCEND-HF and trial-eligible GWTG-HF cohorts, respectively. Compared with trial-enrolled patients, trial-eligible GWTG-HF patients tended to be older with higher blood pressure and higher ejection fraction. Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (all p

Published
2019

17. Assessment of Biomarkers of Myocardial injury, Inflammation, and Renal Function in Heart Failure With Reduced Ejection Fraction: The VICTORIA Biomarker Substudy

Author

DEFILIPPI, CHRISTOPHER R., ALEMAYEHU, WENDIMAGEGN G., VOORS, ADRIAAN A., KAYE, DAVID, BLAUSTEIN, ROBERT O., BUTLER, JAVED, EZEKOWITZ, JUSTIN A., HERNANDEZ, ADRIAN F., LAM, CAROLYN S.P., ROESSIG, LOTHAR, SELIGER, STEPHEN, SHAH, PALAK, WESTERHOUT, CYNTHIA M., ARMSTRONG, PAUL W., and O'CONNOR, CHRISTOPHER M.

Published
2023
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19. Background Medical Therapy and Clinical Outcomes From the VICTORIA Trial

Author

Ezekowitz, Justin A., McMullan, Ciaran J., Westerhout, Cynthia M., Piña, Ileana L., Lopez-Sendon, Jose, Anstrom, Kevin J., Hernandez, Adrian F., Lam, Carolyn S.P., O’Connor, Christopher M., Pieske, Burkert, Ponikowski, Piotr, Roessig, Lothar, Voors, Adriaan A., Koglin, Joerg, Armstrong, Paul W., and Butler, Javed

Published
2023
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21. Evaluation of the hemocompatibility of the Direct Oral Anti-Coagulant apixaban in Left Ventricular Assist Devices (DOAC LVAD) Study

Author

Shah, Palak, primary, Looby, Mary, additional, Dimond, Matthew, additional, Bagchi, Pramita, additional, Shah, Bhruga, additional, Isseh, Iyad, additional, Rollins, Allman T., additional, Abdul-Aziz, Ahmad A., additional, Kennedy, Jamie, additional, Tang, Daniel G., additional, Klein, Katherine M., additional, Casselman, Samantha, additional, Vermeulen, Christen, additional, Sheaffer, Wendy, additional, Snipes, Meredith, additional, Sinha, Shashank S., additional, and O’Connor, Christopher M., additional

Published
2024
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22. Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel

Author

Psotka, Mitchell A., Abraham, William T., Fiuzat, Mona, Filippatos, Gerasimos, Lindenfeld, JoAnn, Ahmad, Tariq, Felker, G. Michael, Jacob, Richard, Kitzman, Dalane W., Leifer, Eric S., Lewis, Eldrin F., Mentz, Robert J., Nkulikiyinka, Richard, Ni, Wei, Schaber, Daniel E., Sharma, Abhinav, Solomon, Scott D., Stockbridge, Norman, Teerlink, John R., Unger, Ellis F., Whellan, David J., Wittes, Janet, Anker, Stefan D., and O’Connor, Christopher M.

Published
2022
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23. Optimal medical therapy with or without surgical revascularization and long-term outcomes in ischemic cardiomyopathy

Author

Dabrowski, Rafal, Djokovic, Ljubomir, Drazner, Mark, Haddad, Haissam, Ali, Imtiaz S., Keltai, Matyas, Naik, Ajay, Sopko, George, Golba, Krzysztof, Andersson, Bert, Carson, Peter, Kukulski, Tomasz, Farsky, Pedro S., White, Jennifer, Al-Khalidi, Hussein R., Sueta, Carla A., Rouleau, Jean L., Panza, Julio A., Velazquez, Eric J., and O'Connor, Christopher M.

Published
2022
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24. Heart Failure Site-Based Research in the United States Results of the Heart Failure Society of America Research Network Survey

Author

Psotka, Mitchell A, Ammon, Susan E, Fiuzat, Mona, Bozkurt, Biykem, Chung, Eugene S, Cole, Robert T, Greene, Stephen J, Kraus, David, Ky, Bonnie, McIlvennan, Colleen K, Shah, Palak, Teerlink, John R, Walsh, Mary Norine, Jessup, Mariell, and O'Connor, Christopher M

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Cardiovascular, Heart Disease, Clinical Trials and Supportive Activities, Clinical Research, Academic Medical Centers, Biomedical Research, Clinical Trials as Topic, Contracts, Cross-Sectional Studies, Ethics Committees, Research, Heart Failure, Humans, Nurse Practitioners, Nurses, Patient Selection, Physicians, Research Personnel, Research Support as Topic, Societies, Medical, Surveys and Questionnaires, Time Factors, United States, clinical trials, heart failure clinical research, research network, site-based research, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

ObjectivesThis study sought to determine clinician and scientist involvement in heart failure (HF) clinical research and to describe the challenges of conducting clinical trials in the United States.BackgroundImprovements in the current capability, potential, and deficiencies of the HF clinical research infrastructure in the United States are needed in order to enhance efficiency and impact.MethodsThe Heart Failure Society of America (HFSA) distributed an electronic survey regarding HF clinical trial activity for the purpose of understanding the barriers that exist to conducting high-quality HF clinical research.ResultsOverall, 1,794 HFSA members were queried, and 434 members (24%) completed surveys, whereas a total of 7,589 individuals with interest in HF were queried, and 615 completed surveys. Of the respondents, 410 (67%) were actively engaged in HF research and 120 (20%) were interested in research. Most respondents, 270, were physicians (44%); 311 of the total (76% of the total and 80% of physicians) practiced in academic institutions; 333 respondents (81%) had served as principal investigators and 73 (18%) as site coordinators. Respondents active in clinical research usually participated in 1 to 5 trials and enrolled 1 to 20 patients annually. Institutional review board (IRB) approval typically required 3 months, and contract completion required 3 to 6 months per site. The greatest barriers to research were insufficient site budgets, delay in contracting, inability to find participants meeting trial entry criteria, and unavailability of qualified study coordinators.ConclusionsMany U.S. clinical research sites are constrained by budgetary, staffing, and contractual issues. The HFSA Research Network seeks to unify interested sites and deconstruct barriers to permit high-value HF research.

Published
2019

25. A Standardized and Regionalized Network of Care for Cardiogenic Shock

Author

Tehrani, Behnam N., Sherwood, Matthew W., Rosner, Carolyn, Truesdell, Alexander G., Ben Lee, Seiyon, Damluji, Abdulla A., Desai, Mehul, Desai, Shashank, Epps, Kelly C., Flanagan, Michael C., Howard, Edward, Ibrahim, Nasrien, Kennedy, Jamie, Moukhachen, Hala, Psotka, Mitchell, Raja, Anika, Saeed, Ibrahim, Shah, Palak, Singh, Ramesh, Sinha, Shashank S., Tang, Daniel, Welch, Timothy, Young, Karl, deFilippi, Christopher R., Speir, Alan, O’Connor, Christopher M., and Batchelor, Wayne B.

Published
2022
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29. A Composite Score Summarizing Use and Dosing of Evidence-Based Medical Therapies in Heart Failure: A Nationwide Cohort Study

Author

Johansen, Niklas Dyrby, Vaduganathan, Muthiah, Zahir, Deewa, Fiuzat, Mona, DeFilippis, Ersilia M., Januzzi, James L., Butler, Javed, O’Connor, Christopher M., Abraham, William T., Psotka, Mitchell A., McMurray, John J.V., Dewan, Pooja, Claggett, Brian L., Solomon, Scott D., Modin, Daniel, Butt, Jawad H., Jensen, Jens Ulrik Stæhr, Schou, Morten, Torp-Pedersen, Christian, Køber, Lars, Gislason, Gunnar H., and Biering-Sørensen, Tor

Published
2023
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32. Dose-limiting, adverse event–associated bradycardia with β-blocker treatment of atrial fibrillation in the GENETIC-AF trial

Author

Abraham, William T., Piccini, Jonathan P., Dufton, Christopher, Carroll, Ian A., Healey, Jeffrey S., O’Connor, Christopher M., Marshall, Debra, Aleong, Ryan, van Veldhuisen, Dirk J., Rienstra, Michiel, Wilton, Stephen B., White, Michel, Sauer, William H., Anand, Inder S., Huebler, Sophia P., Connolly, Stuart J., and Bristow, Michael R.

Published
2022
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33. Proteomics Identify Clinical Phenotypes and Predict Functional Outcomes in Heart Failure With Preserved Ejection Fraction: Insights From VITALITY-HFpEF.

Author

deFilippi, Christopher R., Shah, Palak, Shah, Sanjiv J., Alemayehu, Wendimagegn, Lam, Carolyn S. P., Butler, Javed, Roessig, Lothar, O’Connor, Christopher M., Westerhout, Cynthia M., and Armstrong, Paul W.

Abstract

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) is a heterogeneous syndrome that may emerge from overlapping systemic processes associated with comorbidities. We assessed whether unique clusters of circulating proteins are associated with specific clinical characteristics and functional status at baseline and follow-up in a well-phenotyped cohort of patients with HFpEF. METHODS: We evaluated 368 proteins associated with cardiovascular disease and inflammation in prerandomization blood samples from 763 VITALITY-HFpEF (Vericiguat to Improve Physical Functioning in Daily Living Activities of Patients With HFpEF) participants who had a left ventricular ejection fraction ≥45% and a heart failure decompensation event within 6 months. Proteins were clustered, and their associations with clinical characteristics, baseline, and 24-week functional outcomes (Kansas City Cardiomyopathy Questionnaire Physical Limitation Score, 6-minute walk distance [6MWD], and Fried frailty phenotype) were estimated with linear regression. Elastic net regression was used to derive a proteomic summary composite to predict changes in 24-week functional outcomes. RESULTS: Four unique protein clusters were identified, containing 24, 66, 197, and 81 proteins. At baseline, 2 protein clusters with the hub proteins caspase-3 and Dickkopf-related protein 1 were associated with increased frailty, whereas the cluster with tumor necrosis factor receptor 1 as a hub protein was associated with lower Kansas City Cardiomyopathy Questionnaire Physical Limitation Score and shorter 6MWD. By contrast, the cluster with protein C as a hub protein was associated with less frailty and longer a 6MWD. The 24-week increase in 6MWD was negatively correlated with the protein cluster with caspase-3; the protein C cluster was correlated with less frailty at 24 weeks. The baseline proteomic summary composite predicted observed changes in Kansas City Cardiomyopathy Questionnaire Physical Limitation Score and 6MWD at 24 weeks (r=0.42 and 0.30; P<0.001 for both). CONCLUSIONS: Proteomics differentiate specific baseline functional traits associated with HFpEF and may facilitate phenotyping in a heterogeneous disease. These proteins also provide insights into the diverse pathophysiology of HFpEF and which patients may improve functional status during follow-up. [ABSTRACT FROM AUTHOR]

Published
2024
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37. Reassessing the Role of Surrogate End Points in Drug Development for Heart Failure

Author

Greene, Stephen J, Mentz, Robert J, Fiuzat, Mona, Butler, Javed, Solomon, Scott D, Ambrosy, Andrew P, Mehta, Cyrus, Teerlink, John R, Zannad, Faiez, and O'Connor, Christopher M

Subjects
Clinical Trials and Supportive Activities, Cardiovascular, Clinical Research, Heart Disease, Cardiovascular Agents, Clinical Trials, Phase II as Topic, Consensus, Drug Development, Endpoint Determination, Heart Failure, Humans, Research Design, Treatment Outcome, biomarkers, clinical trial, drug discovery, endpoint determination, heart failure, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

With few notable exceptions, drug development for heart failure (HF) has become progressively more challenging, and there remain no definitively proven therapies for patients with acute HF or HF with preserved ejection fraction. Inspection of temporal trends suggests an increasing rate of disagreement between early-phase and phase III trial end points. Preliminary results from phase II HF trials are frequently promising, but increasingly followed by disappointing phase III results. Given this potential disconnect, it is reasonable to carefully re-evaluate the purpose, design, and execution of phase II HF trials, with particular attention directed toward the surrogate end points commonly used by these studies. In this review, we offer a critical reappraisal of the role of phase II HF trials and surrogate end points, highlighting challenges in their use and interpretation, lessons learned from past experiences, and specific strengths and weaknesses of various surrogate outcomes. We conclude by proposing a series of approaches that should be considered for the goal of optimizing the efficiency of HF drug development. This review is based on discussions between scientists, clinical trialists, industry and government sponsors, and regulators that took place at the Cardiovascular Clinical Trialists Forum in Washington, DC, on December 2, 2016.

Published
2018

38. Is Time of the Essence? The Impact of Time of Hospital Presentation in Acute Heart Failure Insights From ASCEND-HF Trial

Author

Cerbin, Lukasz P, Ambrosy, Andrew P, Greene, Stephen J, Armstrong, Paul W, Butler, Javed, Coles, Adrian, DeVore, Adam D, Ezekowitz, Justin A, Hernandez, Adrian F, Metra, Marco, Starling, Randall C, Tang, Wilson, Teerlink, John R, Voors, Adriaan A, Wu, Angie, O’Connor, Christopher M, and Mentz, Robert J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Research, Cardiovascular, Good Health and Well Being, Acute Disease, After-Hours Care, Aged, Dyspnea, Emergency Service, Hospital, Female, Heart Failure, Humans, Male, Middle Aged, Mortality, Nitroglycerin, Patient Readmission, Posture, Prognosis, Proportional Hazards Models, Respiratory Sounds, Sodium Potassium Chloride Symporter Inhibitors, Time Factors, Vasodilator Agents, heart failure, presentation, ASCEND-HF, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

OBJECTIVES:As the largest acute heart failure (AHF) trial conducted to date, the global ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial database presented an opportunity to systematically describe the relationship among time of hospital presentation, clinical profile, inpatient management, and outcomes among patients admitted with AHF. BACKGROUND:Time of hospital presentation has been shown to impact outcomes among patients hospitalized with many conditions. However, the association among time of presentation and patient characteristics, management, and clinical outcomes among patients hospitalized with AHF has not been well characterized. METHODS:A post hoc analysis of the ASCEND-HF trial was performed, which enrolled 7,141 patients hospitalized for AHF. Patients were divided based on when they presented to the hospital; regular hours were defined as 9 am to 5 pm, Monday through Friday, and off hours were defined as 5 pm to 9 am, Monday through Friday and weekends. Clinical characteristics and outcomes were compared by time of presentation. RESULTS:Overall, 3,298 patients (46%) presented during off hours. Off-hour patients were more likely to have orthopnea (80% vs. 74%, respectively) and rales (56% vs. 49%, respectively) than regular-hour patients. Off-hour patients were more likely to receive intravenous (IV) nitroglycerin (18% vs. 11%, respectively) and IV loop diuretics (92% vs. 86%, respectively) as initial therapy and reported greater relief from dyspnea at 24 h (odds ratio [OR]: 1.14; 95% confidence interval [CI]: 1.04 to 1.24; p = 0.01) than regular-hour patients. After adjustment, off-hour presentation was associated with significantly lower 30-day mortality (OR: 0.74; 95% CI: 0.57 to 0.96; p = 0.03) and 180-day mortality (hazard ratio [HR]: 0.82; 95% CI: 0.72 to 0.94; p = 0.01) but similar 30-day rehospitalization rates (p = 0.40). CONCLUSIONS:In this AHF trial, patients admitted during off hours exhibited a distinct clinical profile, experienced greater dyspnea relief, and had lower post-discharge mortality than regular-hour patients. These findings have implications for future AHF trials.

Published
2018

39. The Impact of Depression on Outcomes in Patients With Heart Failure and Reduced Ejection Fraction Treated in the GUIDE-IT Trial

Author

CHOUAIRI, FOUAD, FUERY, MICHAEL A., MULLAN, CLANCY W., CARABALLO, CESAR, SEN, SOUNOK, MAULION, CHRISTOPHER, WILKINSON, SAMUEL T., SURTI, TORAL, MCCULLOUGH, MEGAN, MILLER, P. ELLIOTT, PACOR, JUSTIN, LEIFER, ERIC S., FELKER, G. MICHAEL, VELAZQUEZ, ERIC J., FIUZAT, MONA, O'CONNOR, CHRISTOPHER M., JANUZZI, JAMES L, DESAI, NIHAR R., and AHMAD, TARIQ

Published
2021
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45. Intercountry Differences in Guideline-Directed Medical Therapy and Outcomes Among Patients With Heart Failure

Author

Fuery, Michael A., Chouairi, Fouad, Januzzi, James L., Moe, Gordon W., Caraballo, Cesar, McCullough, Megan, Miller, P. Elliott, Reinhardt, Samuel W., Clark, Katherine, Oseran, Andrew, Milner, Aidan, Pacor, Justin, Kahn, Peter A., Singh, Avinainder, Ravindra, Neal, Guha, Avirup, Vadlamani, Lina, Kulkarni, Neeti S., Fiuzat, Mona, Felker, G. Michael, O’Connor, Christopher M., Ahmad, Tariq, Ezekowitz, Justin, and Desai, Nihar R.

Published
2021
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49. Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study

Author

Felker, G. Michael, McMurray, John J.V., Cleland, John G., O’Connor, Christopher M., Teerlink, John R., Voors, Adriaan A., Belohlavek, Jan, Böhm, Michael, Borentain, Maria, Bueno, Hector, Cole, Robert T., DeSouza, Mary M., Ezekowitz, Justin A., Filippatos, Gerasimos, Lang, Ninian N., Kessler, Paul D., Martinez, Felipe A., Mebazaa, Alex, Metra, Marco, Mosterd, Arend, Pang, Peter S., Ponikowski, Piotr, Sato, Naoki, Seiffert, Dietmar, and Ye, June

Published
2021
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50. Identifying Subpopulations with Distinct Response to Treatment Using Plasma Biomarkers in Acute Heart Failure: Results from the PROTECT Trial

Author

Liu, Licette CY, Valente, Mattia AE, Postmus, Douwe, O’Connor, Christopher M, Metra, Marco, Dittrich, Howard C, Ponikowski, Piotr, Teerlink, John R, Cotter, Gad, Davison, Beth, Cleland, John GF, Givertz, Michael M, Bloomfield, Daniel M, van Veldhuisen, Dirk J, Hillege, Hans L, van der Meer, Peter, and Voors, Adriaan A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Cardiovascular, Clinical Research, Heart Disease, Acute Disease, Aged, Biomarkers, Diuretics, Female, Heart Failure, Humans, Male, Xanthines, Acute heart failure, Treatment heterogeneity, Subpopulation treatment effect pattern plot, Rolofylline, Pharmacology and Pharmaceutical Sciences, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Pharmacology and pharmaceutical sciences
Abstract

BackgroundOver the last 50 years, clinical trials of novel interventions for acute heart failure (AHF) have, with few exceptions, been neutral or shown harm. We hypothesize that this might be related to a differential response to pharmacological therapy.MethodsWe studied the magnitude of treatment effect of rolofylline across clinical characteristics and plasma biomarkers in 2033 AHF patients and derived a biomarker-based responder sum score model. Treatment response was survival from all-cause mortality through day 180.ResultsIn the overall study population, rolofylline had no effect on mortality (HR 1.03, 95% CI 0.82-1.28, p = 0.808). We found no treatment interaction across clinical characteristics, but we found interactions between several biomarkers and rolofylline. The biomarker-based sum score model included TNF-R1α, ST2, WAP four-disulfide core domain protein HE4 (WAP-4C), and total cholesterol, and the score ranged between 0 and 4. In patients with score 4 (those with increased TNF-R1α, ST2, WAP-4C, and low total cholesterol), treatment with rolofylline was beneficial (HR 0.61, 95% CI 0.40-0.92, p = 0.019). In patients with score 0, treatment with rolofylline was harmful (HR 5.52, 95% CI 1.68-18.13, p = 0.005; treatment by score interaction p

Published
2017

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