Related Experiment Video
Updated: Oct 4, 2025
Post-Myocardial Infarction Heart Failure in Closed-chest Coronary Occlusion/Reperfusion Model in Göttingen Minipigs and Landrace Pigs
Published on: April 17, 2021
Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the
Mona Fiuzat1, Carine E Hamo2, Javed Butler3
1Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA.
Insights
Standardizing background therapy in heart failure (HF) clinical trials is crucial for evaluating new treatments. This discussion explored the necessity and approaches for consistent HF drug therapy in research.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- Heart failure (HF) therapies require standardized background treatments for novel drug evaluation.
- Current HF treatment landscape necessitates defining a consistent study baseline.
Purpose of the Study:
- To discuss the necessity of standardizing background drug therapy in heart failure clinical trials.
- To explore conceptual approaches for standardizing background therapies in HF research.
Main Methods:
- Convened a multistakeholder group including investigators, clinicians, patients, regulators, and industry representatives.
- Summarized discussions on standardizing background drug therapy for heart failure trials.
Main Results:
- Identified a need for standardized background therapy in heart failure clinical trials.
- Proposed conceptual approaches for therapy standardization.
Conclusions:
- Standardization of background therapy is essential for robust heart failure clinical trial design.
- Focus remains on therapies for heart failure with reduced ejection fraction (HFrEF).
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.
More Related Videos
12:45Benefits of Cardiac Resynchronization Therapy in an Asynchronous Heart Failure Model Induced by Left Bundle Branch Ablation and Rapid Pacing
Published on: December 11, 2017
10:05Testing the Efficacy of Pharmacological Agents in a Pericardial Target Delivery Model in the Swine
Published on: July 7, 2016