Incretin Therapies in Obesity-related HFpEF
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorColumbia University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tirzepatide
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov