Recruiting

Tirzepatide

Sponsor:

Columbia University

Code:

NCT07554638

Conditions

Heart Failure, Diastolic

Heart Failure With Preserved Ejection Fraction

Obesity

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Study Details

Brief summary:

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.

Conditions

Heart Failure, Diastolic

Heart Failure With Preserved Ejection Fraction

Obesity

Study ID

NCT07554638

Start date

Aug 7, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tirzepatide

After a 3-month control period, participants will be prescribed tirzepatide and undergo serial plasma volume measurement and body composition analysis. Participants will be prescribed tirzepatide under the brand name Monjauro if they have diabetes, and under the brand name Zepbound if they do not have diabetes. All participants will be initiated on an initial dose of 2.5 mg injected subcutaneously in the thigh or abdomen every week on same day and at the same time.

Interventions

Tirzepatide

Glucagon-like 1 receptor agonist/glucose-dependent insulinotropic polypeptide receptor agonist

Primary outcome measure

  • Plasma volume [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Jessica Idumonyi

212-305-1429joi2102@cumc.columbia.edu

Locations

Columbia University Irving Medical Center (CUIMC) / NewYork Presbyterian Hospital (NYP)

Recruiting

New York, New York, United States, 10032

More Information

Sponsor

Columbia University

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-08-24.