Incretin Therapies in Obesity-related HFpEF
Identifying Therapeutic Mechanisms for Incretin-Based Treatment in Obesity-Related Heart Failure With Preserved Ejection Fraction (HFpEF)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The investigators will serially measure plasma volume and body composition with quantitative magnetic resonance to determine changes over time with tirzepatide treatment."
- "Quantitative magnetic resonance (QMR) is a highly precise body composition assessment technique that can estimate fat mass, fat-free (lean) mass, free water and total body water (TBW) over time and has been utilized by the research team in other HFpEF cohorts."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether tirzepatide lowers the amount of plasma, the liquid part of blood. It is for people with obesity and heart failure with preserved ejection fraction (HFpEF), whose hearts still pump out a fairly normal share of blood. The study will follow 50 people who qualify for tirzepatide treatment for 15 months.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have heart failure with symptoms that limit physical activity mildly or noticeably (NYHA class II–III).
- A heart test within the past 6 months shows that the heart pumps out at least 45% of its blood with each beat.
- Have at least one qualifying test result: a high level of a heart strain marker in the blood, an enlarged upper left heart chamber, or high pressure as the heart fills.
- Have a body mass index (BMI), a measure of weight compared with height, above 30.
- Have steady doses of heart failure medicines for 4 weeks before screening, with fluid levels well controlled in the study doctor's view.
Who can't join
- Sudden worsening of heart failure within 4 weeks before screening, or a major heart or blood vessel event, such as a heart attack or stroke, within 90 days.
- Another cause of heart failure, such as abnormal protein buildup in the heart, disease that thickens the heart muscle, or severe heart valve disease.
- Very low kidney function (eGFR below 15) or need for dialysis, a treatment that filters the blood.
- Type 1 diabetes, or poorly controlled diabetes with an A1c blood sugar result above 9.5%.
- Past or ongoing pancreatitis, which is swelling of the pancreas, or a major problem with how the stomach empties.
- A personal or family history of multiple endocrine neoplasia (MEN), a condition that causes tumors in hormone-making glands, or medullary thyroid cancer.
- Other health problems that limit survival, or inability to follow study requirements.
- Pregnancy.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
NY
- Columbia University Irving Medical Center (CUIMC) / NewYork Presbyterian Hospital (NYP) · New York, NY 10032More trials in New York