Incretin Therapies in Obesity-related HFpEF
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 40 Years to no upper limit; excludes diabetes; BMI ≥30 required; conditions: Heart Failure, Diastolic; Heart Failure With Preserved Ejection Fraction; Obesity
- Interventions
- Tirzepatide
- Conditions
- Heart Failure, Diastolic; Heart Failure With Preserved Ejection Fraction; Obesity
- Phase and size
- Phase 4 · 50 participants
- Dates
- Start 2026-08-07
Primary completion 2029-04 - Sponsor
- Columbia University (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Plasma volume12 months
02Eligibility
Who can take part
Inclusion Criteria: * Diagnosis of heart failure (HF) per the ACC/AHA guidelines with NYHA class II-III symptoms * Left ventricular ejection fraction \>= 45% within 6 months of recruitment * At least one of the following: elevated N-terminal pro- B-type natriuretic peptide (NT-proBNP) \>=200 pg/ml (\>=600 pg/ml with concurrent atrial fibrillation), evidence of structural heart disease (left atrial (LA) enlargement with LA volume index \>29 mL/m2 or LA diameter \>=40 mm in males/\>38= mm in females), elevated filling pressures (resting wedge \>15 mmHg or exercise wedge \>25 mmHg, lateral E/e' ratio \>12 or septal E/e' \> 15) * Body mass index (BMI) \>30 kg/m2 * Stable doses of HF medications within 4 weeks of screening with optimal volume control in the opinion of the investigator. Exclusion Criteria: * Acute decompensated HF within 4 weeks of screening * Major cardiovascular event within 90 days of screening (myocardial infarction, stroke) * Alternate cause of HFpEF such as cardiac amyloidosis, infiltrative cardiomyopathy, hypertrophic cardiomyopathy, severe valvular disease * Estimated glomerular fibrilation rate (EGFR) \<15 ml/min/1.73m2 or dialysis dependence * Poorly controlled diabetes (A1c \> 9.5%) OR any type 1 diabetes mellitis * History of acute or chronic pancreatitis * Personal or family history of multiple endocrine neoplasia (MEN) or medullary thyroid cancer * Clinically significant gastric emptying abnormality * Medical comorbidities that limit survival * Inability to comply with the study protocol * Pregnancy
03Change log
Registry changes
No changes recorded since the trial was added.