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Incretin Therapies in Obesity-related HFpEF

RecruitingPhase 4

Identifying Therapeutic Mechanisms for Incretin-Based Treatment in Obesity-Related Heart Failure With Preserved Ejection Fraction (HFpEF)

Who can join

Ages 40 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Columbia University · Participants: 50 · Started: Aug 7, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07554638

Locations in the U.S.

New YorkColumbia University Irving Medical Center (CUIMC) / NewYork Presbyterian Hospital (NYP), New York

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.