NCT07554638RecruitingPhase 4
Incretin Therapies in Obesity-related HFpEF
Identifying Therapeutic Mechanisms for Incretin-Based Treatment in Obesity-Related Heart Failure With Preserved Ejection Fraction (HFpEF)
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 21 Apr 2026
- Start date
- 7 Aug 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- Columbia University
- Diseases
- Heart failure, Obesity
- NCT number
- NCT07554638
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 7 Aug 2026 to the primary completion date, Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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
Lab values
- Estimated glomerular fibrilation rate (EGFR) \<15 ml/min/1.73m2 or dialysis dependence
Other
- Acute decompensated HF within 4 weeks of screening
- Clinically significant gastric emptying abnormality
- Medical comorbidities that limit survival
- Inability to comply with the study protocol
- Pregnancy
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center (CUIMC) / NewYork Presbyterian Hospital (NYP) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.