Double-blind, Prospective, Randomized, Placebo-controlled Trial to Assess if Activin Ligand-trap Biological Therapy Can Improve Exercise Capacity and Cognitive Function in Heart Failure With Preserved Ejection Fraction Compared to Placebo.
Massachusetts General Hospital
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.
Description
A double-blind, prospective, phase 2 randomized, placebo-controlled 24-week clinical trial to assess exercise tolerance after activin-ligand trap biological therapy compared to placebo in HFpEF patients with a primary endpoint of change in peak VO2. Forty-eight participants with HFpEF who are overweight or obese will be recruited from the Cardiopulmonary Exercise Testing (CPET) Laboratory and will have a recent or scheduled clinical care CPET. These measurements will serve as baseline measures. After undergoing other baseline measurements such as actigraphy, blood studies, DEXA scan, Kansas C…
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult ≥ 40 years of age; 2. Body mass index ≥ 27 kg/m2; 3. Left ventricular ejection fraction (LVEF) ≥ 0.50 with NYHA II-III; 4. Established diagnosis of HFpEF based on medical history supported by at least one of the following 5 criteria (i through v, below) i. Documented hospitalization with HFpEF as a primary cause or other urgent outpatient visit for acute HFpEF (as primary cause) at which IV loop diuretic was provided as treatment (≥ 1 month prior to screening); ii. Increased left atrial (LA) size: AP dimension: ≥ 4.0 in men, \> 3.8 in women; or LA length ≥…
Interventions
- DrugActivin ligand-trap biological therapy
Investigational therapy
- DrugPlacebo, Normal Saline
Inactive drug
Location
- Massachusetts General HospitalBoston, Massachusetts