Incretin Therapies in Obesity-related HFpEF

Sponsor
Columbia University
Study ID
NCT07554638
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Tirzepatide — DRUG
    Glucagon-like 1 receptor agonist/glucose-dependent insulinotropic polypeptide receptor agonist

Study Details

The central hypothesis to be tested is that patients with obesity and heart failure with preserved ejection fraction (HFpEF) prescribed tirzepatide will demonstrate reductions in measured plasma volume. In conjunction with state-of-the-art body composition analysis and measures of adipokines, this will establish an important mechanism of clinical benefit and inform disease pathophysiology. To accomplish this, this study will perform a 15-month prospective cohort study in 50 patients with obesity and HFpEF who clinically qualify for treatment with tirzepatide. The investigators will serially measure plasma volume and body composition with quantitative magnetic resonance to determine changes over time with tirzepatide treatment.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    After a 3-month control period, participants will be prescribed tirzepatide and undergo serial plasma volume measurement and body composition analysis. Participants will be prescribed tirzepatide under the brand name Monjauro if they have diabetes, and under the brand name Zepbound if they do not have diabetes. All participants will be initiated on an initial dose of 2.5 mg injected subcutaneously in the thigh or abdomen every week on same day and at the same time.

Primary Outcome Measure

Plasma volume [ Time Frame: 12 months ]

Central Contacts

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