Clinical trial

Incretin Therapies in Obesity-related HFpEF

Recruiting now · Phase 4 · 1 countries · Registry ID NCT07554638

Recruiting nowPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionHeart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction, Obesity

Full registry 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

Treatments and study arms

Tirzepatide

Drug

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

Primary outcomes

Plasma volume12 months

Plasma volume is measured using 131-iodine labeled serum albumin. The isotope is injected via an intravenous line and serial blood samples are taken and analyzed using the Blood Volume Analyzer-100 to derive the participant's blood volume and plasma volume. This will be performed at serial visits to determine the effect of tirzepatide therapy on measured plasma volume over time.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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