Clinical Trial

EXercise and Activin Inhibition to Modulate InflammatioN Effects on Heart Failure and Cognition (EXAMINE-HFC)

Study acronym: EXAMINE-HFC
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if therapy with activin ligand-trap biological therapy (an investigational drug) combined with exercise training can improve exercise capacity and cognitive function in heart failure with preserved ejection fraction (HFpEF). The main questions it aims to answer are: * Does activin-ligand trap biological therapy improve exercise capacity as measured by change in peak oxygen uptake (peak VO2) from baseline to week 12? * Does activin-ligand trap biological therapy improve cognitive function as assessed by the NIH-Toolbox Cognition Battery (NIHTB-CB) composite score and Rey Auditory Verbal Learning Test (RAVLT) from baseline to week 12? Researchers will compare activin-ligand trap biological therapy to a placebo (a look-alike substance that contains no drug) to see if activin-ligand trap therapy works to improve exercise capacity and cognitive function in patients with HFpEF.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-10
Trial Details
NCT Number NCT07202000
Lead Sponsor Massachusetts General Hospital
Collaborators: American Heart Association, University of Michigan, Oakland University
Conditions Heart Failure With Preserved Ejection Fraction
Enrollment 48 participants
Start Date 2026-06-03
Primary Completion 2027-07 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-09