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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Adult ≥ 40 years of age;

Body mass index ≥ 27 kg/m2;

Left ventricular ejection fraction (LVEF) ≥ 0.50 with NYHA II-III;

Established diagnosis of HFpEF based on medical history supported by at least one of the following 5 criteria (i through v, below)

Disqualifiers

Conditions anticipated to independently impact exercise capacity or clinical stability during the trial period

Current or recent (within 30 days) acute decompensated HF requiring intravenous diuretics or hospitalization;

Initiation of treatment with GLP-1 receptor agonist or SGLT2 inhibitor within 60 days of screening;

Planned cardiac surgery or catheter intervention during the period of trial participation;

Trial design

Treatments tested in this trial

  • Activin ligand-trap biological therapy
  • Placebo, Normal Saline

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

American Heart Association

Collaborator

University of Michigan

Collaborator

Oakland University

Collaborator