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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07202000
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Activin ligand-trap biological therapy — DRUG
    Investigational therapy
  • Placebo, Normal Saline — DRUG
    Inactive drug

Study Details

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.

Key Dates

First listed
Oct 1, 2025
Start date
Jun 3, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Activin ligand-trap biological therapy (KER-012) subcutaneously (SC) 1.5mg/kg every 4 weeks X 3
    Activin ligand-trap biological therapy subcutaneously in addition to an individualized physical activity program for 12 weeks before the crossover.
  • Placebo Comparator: Normal Saline subcutaneous injection every 4 weeks X 3
    Patients will receive placebo in addition to an individualized physical activity program for 12 weeks before the crossover.

Primary Outcome Measure

Change in peak oxygen uptake (peak VO2) in HFpEF subjects following activin ligand-trap biological therapy or placebo. [ Time Frame: From baseline to week 12 and from week 12 to week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Gregory D. Lewis, MD
[email protected]
6177249254
Diane Cocca-Spofford, BSN
[email protected]
617 726 8228

Find similar trials in Boston, MA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Massachusetts General Hospital· Boston, MA

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