Tirzepatide and Body Fluid Volume in Obesity With Preserved-Ejection Heart Failure
Studies how tirzepatide changes plasma volume in people with obesity and HFpEF.
Plain-language title generated from the registry record
Registry title: Incretin Therapies in Obesity-related HFpEF
Key facts
- Where
- New York, United StatesSee the site
- Phase
- Phase 4
Where in United States
- Columbia University Irving Medical Center (CUIMC) / NewYork Presbyterian Hospital (NYP)New York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Columbia University
- Trial code
- NCT07554638
- Record updated
- 24 August 2026
- Original description
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.Read full original descriptionShow less
Identifying Therapeutic Mechanisms for Incretin-Based Treatment in Obesity-Related Heart Failure With Preserved Ejection Fraction (HFpEF)
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.
Inclusion: 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: 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; Estimated glomerular fibrilation rate (EGFR) <15 ml/min/1.73m2 or dialysis dependence; 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.