Incretin therapy with tirzepatide for obesity-related HFpEF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 4, interventional study enrolling 50 adults with obesity and HFpEF who are eligible to receive tirzepatide. Participants will be treated with tirzepatide and followed over 15 months with serial measurements of plasma volume, body composition, and adipokines using quantitative magnetic resonance to understand potential mechanisms of benefit. The study aims to link changes in body composition and adipokine signals to clinical outcomes in this high-risk population. Results could clarify how incretin therapies modulate fluid balance and heart failure pathophysiology in obesity-related HFpEF.

Why it matters

Who can join: the full rules

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

Where it's running

• Columbia University Irving Medical Center (CUIMC) / NewYork Presbyterian Hospital (NYP)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Elissa A Driggin, MD — Columbia University
• Study coordinator: Jessica Idumonyi
• Email: joi2102@cumc.columbia.edu
• Phone: 212-305-1429

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.