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Incretin Therapies in Obesity-related HFpEF

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of Jun 2026 to Aug 7, 2026v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2026 to Aug 7, 2026
  2. Minor Secondary endpoints: details revised at 1 of 2 entriesv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07554638
Lead Sponsor Columbia University
Conditions Heart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction, Obesity
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov