Heart Failure

Overview

The Accelerating Medicines Partnership^® (AMP^®) program is a public-private partnership between the National Institutes of Health (NIH), the US Food and Drug Administration (FDA), multiple biopharmaceutical and life sciences companies, and non-profit organizations. Managed through the Foundation for the NIH (FNIH), the AMP program identifies disease targets to validate the most promising and effective treatments.

The AMP Heart Failure (AMP HF) program, which focuses on heart failure with preserved ejection fraction (HFpEF), launched in September 2022. The program is investigating the multiple factors that lead to HFpEF and seeks to determine the phenotypes that constitute this complex, heterogenous syndrome.

About Heart Failure with Preserved Ejection Fraction

Heart failure (HF) is a condition in which the heart cannot meet the body’s oxygen and nutrient needs either due to defects in the heart muscle contracting or the heart chamber filling. Ejection fraction (EF) is a measure of whether the left ventricle—the main pumping chamber of the heart—is pumping normally or abnormally.

HFpEF is a type of heart failure that displays normal ejection fraction in the left ventricle—the ventricle contracts and pumps normally; however, its stiffness prevents it from relaxing and filling normally between heartbeats. As a result, the left ventricle exhibits a higher pressure at rest. Medically, HFpEF is defined as heart failure with a left ventricular ejection fraction that is greater than or equal to 50% and elevated left ventricular filling pressures at rest or during exercise, diagnosed after careful exclusion of conditions that may mimic HFpEF.

Need for New Therapies

Although compelling progress has been made in the treatment of many forms of heart disease, death due to heart failure continues to rise nationally. HFpEF is considered the single largest unmet need in cardiovascular medicine that affects 64 million persons globally and constitutes approximately 50% of all heart failure cases. Patients with HFpEF face an extraordinarily high risk for mortality, recurrent hospitalizations, and reduced quality of life and functional capacity. Currently, no therapies have convincingly reduced mortality. The AMP HF program aims to identify HFpEF subtypes to discover new treatment targets.

AMP Approach

The AMP Heart Failure program uses two complementary and integrated research components that will run simultaneously. In Component I, researchers will combine and analyze existing HFpEF datasets that are sourced from studies funded by the public and private sectors. In Component II, researchers will create and run a new deep phenotyping study based on current best practices and existing research to develop a framework for new precision treatments.

The AMP Heart Failure program will use cutting-edge technologies, including digital measurements and artificial intelligence analytic methods, to find novel proteins or genes that could alleviate this disease. Further, the program will use imaging, multi-omics in blood and other tissues, and deep clinical phenotyping to identify disease subtypes and novel biologic pathways underlying development and progression of HFpEF, with the goal of advancing effective targeted therapeutics.

Governance

The AMP HF Steering Committee (SC), including six subcommittees, is organized by the FNIH and includes representatives from the clinical sites, data translation center, and each of the partner organizations. The SC operates under the direction of the overall AMP Executive Committee and is responsible for defining and maintaining the research plan, reviewing progress of the project, and providing detailed assessment of milestones for AMP HF. Working groups created under the direction of the AMP HF SC will provide detailed technical analyses of key scientific, policy, or informatics issues that arise during implementation.

Budget: 5 years ($37 Million Total Project Funding)