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

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

doi:10.1016/j.jacc.2021.11.033

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

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

Icahn School of Medicine at Mount Sinai

Research output: Contribution to journal › Review article › peer-review

76 Scopus citations

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.

Original language	English
Pages (from-to)	504-510
Number of pages	7
Journal	Journal of the American College of Cardiology
Volume	79
Issue number	5
DOIs	https://doi.org/10.1016/j.jacc.2021.11.033
State	Published - 8 Feb 2022

Keywords

FDA
HFrEF
clinical trials
device therapy
drug therapy
guideline directed medical therapy
heart failure
medical therapy
medication

Access to Document

10.1016/j.jacc.2021.11.033

Cite this

Fiuzat, M., Hamo, C. E., Butler, J., Abraham, W. T., DeFilippis, E. M., Fonarow, G. C., Lindenfeld, J., Mentz, R. J., Psotka, M. A., Solomon, S. D., Teerlink, J. R., Vaduganathan, M., Vardeny, O., McMurray, J. J. V., & O'Connor, C. M. (2022). Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week. Journal of the American College of Cardiology, 79(5), 504-510. https://doi.org/10.1016/j.jacc.2021.11.033

@article{ddd9fd58dd044640a660c9a9138ec8c6,

title = "Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week",

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.",

keywords = "FDA, HFrEF, clinical trials, device therapy, drug therapy, guideline directed medical therapy, heart failure, medical therapy, medication",

author = "Mona Fiuzat and Hamo, \{Carine E.\} and Javed Butler and Abraham, \{William T.\} and DeFilippis, \{Ersilia M.\} and Fonarow, \{Gregg C.\} and Joann Lindenfeld and Mentz, \{Robert J.\} and Psotka, \{Mitchell A.\} and Solomon, \{Scott D.\} and Teerlink, \{John R.\} and Muthiah Vaduganathan and Orly Vardeny and McMurray, \{John J.V.\} and O'Connor, \{Christopher M.\}",

note = "Publisher Copyright: {\textcopyright} 2022 The Authors",

year = "2022",

month = feb,

day = "8",

doi = "10.1016/j.jacc.2021.11.033",

language = "English",

volume = "79",

pages = "504--510",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier Inc.",

number = "5",

}

Fiuzat, M, Hamo, CE, Butler, J, Abraham, WT, DeFilippis, EM, Fonarow, GC, Lindenfeld, J, Mentz, RJ, Psotka, MA, Solomon, SD, Teerlink, JR, Vaduganathan, M, Vardeny, O, McMurray, JJV & O'Connor, CM 2022, 'Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week', Journal of the American College of Cardiology, vol. 79, no. 5, pp. 504-510. https://doi.org/10.1016/j.jacc.2021.11.033

TY - JOUR

T1 - Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials

T2 - JACC Review Topic of the Week

AU - Fiuzat, Mona

AU - Hamo, Carine E.

AU - Butler, Javed

AU - Abraham, William T.

AU - DeFilippis, Ersilia M.

AU - Fonarow, Gregg C.

AU - Lindenfeld, Joann

AU - Mentz, Robert J.

AU - Psotka, Mitchell A.

AU - Solomon, Scott D.

AU - Teerlink, John R.

AU - Vaduganathan, Muthiah

AU - Vardeny, Orly

AU - McMurray, John J.V.

AU - O'Connor, Christopher M.

PY - 2022/2/8

Y1 - 2022/2/8

N2 - 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.

AB - 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.

KW - FDA

KW - HFrEF

KW - clinical trials

KW - device therapy

KW - drug therapy

KW - guideline directed medical therapy

KW - heart failure

KW - medical therapy

KW - medication

UR - https://www.scopus.com/pages/publications/85123102798

U2 - 10.1016/j.jacc.2021.11.033

DO - 10.1016/j.jacc.2021.11.033

M3 - Review article

C2 - 35115106

AN - SCOPUS:85123102798

SN - 0735-1097

VL - 79

SP - 504

EP - 510

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 5

ER -

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

Abstract

Keywords

Access to Document

Fingerprint

Cite this