Health TrialsbyHealthPanel

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

ConditionHeart Failure With Preserved Ejection Fraction
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Activin ligand-trap biological therapy

    Drug

    Investigational therapy

  • Placebo, Normal Saline

    Drug

    Inactive drug

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Activin ligand-trap biological therapy (KER-012) subcutaneously (SC) 1.5mg/kg every 4 weeks X 3Active comparator 1 intervention
Group B: Normal Saline subcutaneous injection every 4 weeks X 3Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in peak oxygen uptake (peak VO2) in HFpEF subjects following activin ligand-trap biological therapy or placebo.

Peak VO2 measured by a maximal effort Cardiopulmonary Exercise Test (CPET).

Time frame
From baseline to week 12 and from week 12 to week 24

Secondary outcomes

1

Change in cognitive function.

Changes in cognitive function as assessed by the NIH-Toolbox Cognition Battery (NIHTB-CB) composite score standardized by age.

Time frame
From baseline to week 12 and from week 12 to week 24
2

Change in cognitive function

changes in cognitive function as assessed by comparing the Rey Auditory Verbal Learning Test (RAVLT) score, standardized by age.

Time frame
From Baseline to week 12, and from week 12- 24
3

Change in body composition.

Change in body composition as measured by DEXA scan to compare the % lean muscle mass and absolute quantity of lean muscle mass

Time frame
From baseline to week 12 and week 12 to week 24
4

Change in cardiac function measured by echocardiography

Change in Left Atrium (LA)dimensions (cm)

Time frame
From baseline to week 12 and from week 12 to 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

American Heart Association

Collaborator

University of Michigan

Collaborator

Oakland University

Collaborator

Source ClinicalTrials.gov
Apply now