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3. The need for increased pragmatism in cardiovascular clinical trials

Author

Usman, Muhammad Shariq, Van Spall, Harriette GC, Greene, Stephen J, Pandey, Ambarish, McGuire, Darren K, Ali, Ziad A, Mentz, Robert J, Fonarow, Gregg C, Spertus, John A, Anker, Stefan D, Butler, Javed, James, Stefan K, and Khan, Muhammad Shahzeb

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Comparative Effectiveness Research, Cardiovascular, Heart Disease, Clinical Trials and Supportive Activities, Prevention, Clinical Research, Good Health and Well Being, Cardiovascular Diseases, Humans, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

The majority of cardiovascular randomized controlled trials (RCTs) test interventions in selected patient populations under explicitly protocol-defined settings. Although these 'explanatory' trial designs optimize conditions to test the efficacy and safety of an intervention, they limit the generalizability of trial findings in broader clinical settings. The concept of 'pragmatism' in RCTs addresses this concern by providing counterbalance to the more idealized situation underpinning explanatory RCTs and optimizing effectiveness over efficacy. The central tenets of pragmatism in RCTs are to test interventions in routine clinical settings, with patients who are representative of broad clinical practice, and to reduce the burden on investigators and participants by minimizing the number of trial visits and the intensity of trial-based testing. Pragmatic evaluation of interventions is particularly important in cardiovascular diseases, where the risk of death among patients has remained fairly stable over the past few decades despite the development of new therapeutic interventions. Pragmatic RCTs can help to reveal the 'real-world' effectiveness of therapeutic interventions and elucidate barriers to their implementation. In this Review, we discuss the attributes of pragmatism in RCT design, conduct and interpretation as well as the general need for increased pragmatism in cardiovascular RCTs. We also summarize current challenges and potential solutions to the implementation of pragmatism in RCTs and highlight selected ongoing and completed cardiovascular RCTs with pragmatic trial designs.

Published
2022

13. 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

18. The HFSA Advanced Heart Failure and Transplant Cardiology Fellowship Consensus Conference

Author

DRAZNER, MARK H., AMBARDEKAR, AMRUT V., BERLACHER, KATHRYN, BLUMER, VANESSA, CHATUR, SAFIA, CHENG, RICHARD, CHENG, RICHARD K., GRANDIN, E. WILSON, GORODESKI, EIRAN Z., KATARIA, RACHNA, KATZ, JASON N., KITTLESON, MICHELLE M., KRISHNAMOORTHY, ARUN, LALA, ANURADHA, LENNEMAN, ANDREW J., LOHR, NICOLE L., MARGULIES, KENNETH B., MENTZ, ROBERT J., REZA, NOSHEEN, WILCOX, JANE, YOUMANS, QUENTIN R., ZIEROTH, SHELLEY, and TEERLINK, JOHN R.

Published
2024
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20. 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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21. 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

25. Exercise Intolerance in Older Adults With Heart Failure With Preserved Ejection Fraction JACC State-of-the-Art Review

Author

Pandey, Ambarish, Shah, Sanjiv J, Butler, Javed, Kellogg, Dean L, Lewis, Gregory D, Forman, Daniel E, Mentz, Robert J, Borlaug, Barry A, Simon, Marc A, Chirinos, Julio A, Fielding, Roger A, Volpi, Elena, Molina, Anthony JA, Haykowsky, Mark J, Sam, Flora, Goodpaster, Bret H, Bertoni, Alain G, Justice, Jamie N, White, James P, Ding, Jingzhone, Hummel, Scott L, LeBrasseur, Nathan K, Taffet, George E, Pipinos, Iraklis I, and Kitzman, Dalane

Subjects
Aging, Heart Disease, Cardiovascular, Animals, Exercise Tolerance, Heart Failure, Diastolic, Humans, exercise intolerance, heart failure with preserved ejection fraction, senescence, skeletal muscle, aging, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

Exercise intolerance (EI) is the primary manifestation of chronic heart failure with preserved ejection fraction (HFpEF), the most common form of heart failure among older individuals. The recent recognition that HFpEF is likely a systemic, multiorgan disorder that shares characteristics with other common, difficult-to-treat, aging-related disorders suggests that novel insights may be gained from combining knowledge and concepts from aging and cardiovascular disease disciplines. This state-of-the-art review is based on the outcomes of a National Institute of Aging-sponsored working group meeting on aging and EI in HFpEF. We discuss aging-related and extracardiac contributors to EI in HFpEF and provide the rationale for a transdisciplinary, "gero-centric" approach to advance our understanding of EI in HFpEF and identify promising new therapeutic targets. We also provide a framework for prioritizing future research, including developing a uniform, comprehensive approach to phenotypic characterization of HFpEF, elucidating key geroscience targets for treatment, and conducting proof-of-concept trials to modify these targets.

Published
2021

26. 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

27. 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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49. Natriuretic Peptides: Role in the Diagnosis and Management of Heart Failure: A Scientific Statement From the Heart Failure Association of the European Society of Cardiology, Heart Failure Society of America and Japanese Heart Failure Society

Author

Tsutsui, HIROYUKI, ALBERT, NANCY M., COATS, ANDREW J.S., ANKER, STEFAN D., BAYES-GENIS, ANTONI, BUTLER, JAVED, CHIONCEL, OVIDIU, DEFILIPPI, CHRISTOPHER R., DRAZNER, MARK H., FELKER, G. MICHAEL, FILIPPATOS, GERASIMOS, FIUZAT, MONA, IDE, TOMOMI, JANUZZI, JAMES L., Jr, KINUGAWA, KOICHIRO, KUWAHARA, KOICHIRO, MATSUE, YUYA, MENTZ, ROBERT J., METRA, MARCO, PANDEY, AMBARISH, ROSANO, GIUSEPPE, SAITO, YOSHIHIKO, SAKATA, YASUSHI, SATO, NAOKI, SEFEROVIC, PETAR M., TEERLINK, JOHN, YAMAMOTO, KAZUHIRO, and YOSHIMURA, MICHIHIRO

Published
2023
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