EXercise and Activin Inhibition to Modulate InflammatioN Effects on Heart Failure and Cognition (… (NCT07202000) | Clinical Trial Compass
Not Yet RecruitingPhase 2
EXercise and Activin Inhibition to Modulate InflammatioN Effects on Heart Failure and Cognition (EXAMINE-HFC)
United States48 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
✓. Achievement of a respiratory exchange ratio (RER) at baseline CPET of ≥ 1.05 to ensure maximum volitional effort was provided;
✓. Ambulatory (not wheelchair/scooter-dependent) and able to perform CPET/6MWT/Chair stand evaluations;
✓. Stable dose of medications (defined as no new medication or change in existing dose of medication ≥ 50%) for at least 30 days prior to screening.
Exclusion criteria
✕. 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;
What they're measuring
1
Change in peak oxygen uptake (peak VO2) in HFpEF subjects following activin ligand-trap biological therapy or placebo.
Timeframe: From baseline to week 12 and from week 12 to week 24
✕. 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;
✕. Entry within 30 days of screening or plans to enter a weight loss program and/or cardiac rehabilitation or initiate any new exercise program during the study.
✕. Primary cardiomyopathy (e.g., constrictive, restrictive, infiltrative, toxic, hypertrophic, congenital), LVEF \< 40% within the last 3 years, or active myocarditis;
✕. Lactating, pregnant, or planning to become pregnant;
✕. Non-cardiac organ system dysfunction or sufficient severity to predominate as the source of exercise intolerance in addition to the following specific criteria: pulmonary disease with chronic home daytime supplemental O2 dependence, severe anemia with hemoglobin \< 9 g/dL or chronic kidney disease (CKD) with estimated GFR \< 30 mL/min/1.73m2 based on the CKD-EPI equation.