A Phase 4 interventional study of Tirzepatide in Heart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction and Obesity, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Columbia University · Phase 4, Interventional, and Treatment
Among 95 studies in Heart Failure, Diastolic with a site in United States — 18 open to participants now, 20 under way, none of them phase 3. Heart Failure, Diastolic · United States.
Among the 95 studies in Heart Failure, Diastolic with a site in United States, this one is the 34th largest by planned enrollment of the 81 interventional ones that give a count, is one of 4 that started in 2026, is one of 17 in phase 4, reaches primary completion later than 15 of the 19 other live ones, and was the 93rd registered.
199 studies on the registry are indexed under Heart Failure, Diastolic; 44 are open to participants now.
Browse Heart Failure, Diastolic studies →18 of the 95 studies in Heart Failure, Diastolic with a site in United States are open now. Recruiting first, the newest first:
Tufts Medical Center · Sites in United States
Ages 18+
Eli Lilly and Company · Sites in United States, Japan, Moldova and 2 more countries
Ages 18–65
University of Virginia · Sites in United States
Ages 18–90
Vanderbilt University Medical Center · Sites in United States
Ages 18+ · Women only · Healthy volunteers
Weill Medical College of Cornell University · Sites in United States
Ages 65+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 Heart Failure, Diastolic studies recruiting now, 21 (72%) set no upper age limit and 4 (14%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
95 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 15 · Phase 3 4 · Phase 4 17
First in 2003; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is close to the median of 48 across 139 interventional studies indexed under Heart Failure, Diastolic.
Median enrollment 36 across the 81 interventional studies, 80 across the 14 observational. Of the 70 that completed or were terminated, 34 (49%) have results posted.
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17 of 95 have an industry lead sponsor. The 10 most frequent:
Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Columbia University has 1 study filed under Heart Failure, Diastolic — fewer than ten, so there is no comparison to draw.
6 of the studies in Heart Failure, Diastolic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06009276University of VirginiaAssociations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status | 2026-12 |
| NCT05585125Weill Medical College of Cornell UniversityA Preliminary Study for INFORMED | 2027-02 |
| NCT06937320Duke UniversityChronic Exogenous Ketosis in HFpEF | 2027-06 |
| NCT05425459Corvia MedicalRESPONDER-HF Trial | 2027-07 |
| NCT07057323Mayo ClinicCoronary Sinus Reducer For The Management Of Symptomatic Heart Failure | 2027-08 |
Add all 6 to your calendar (.ics) → With an account.
Among the 95 studies in Heart Failure, Diastolic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
The prevalence of obesity among United States adults is over 40% and is projected to affect over half the population within the coming decade. Obesity is a strong independent risk factor for the development of heart failure (HF) and specifically the phenotype of heart failure with preserved ejection fraction (HFpEF) of whom 84% have obesity. Accordingly, anti-obesity medications are a major focus of recent clinical investigation in patients with obesity and HFpEF. Randomized controlled trials studying incretin mimetics, including glucagon-like peptide 1 (GLP1) receptor agonist (semaglutide) and GLP1/glucose-dependent insulinotropic (GIP) receptor co-agonists (tirzepatide), have improved clinical outcomes patients with obesity and HFpEF. The mechanisms underlying the clinical benefit remain incompletely understood.
Patients with obesity and HFpEF demonstrate distinct structural and hemodynamic features mediated in part by plasma volume (PV) expansion. A major mechanism responsible for PV expansion in obesity is elevated serum leptin, an adipokine with a concentration directly proportional to fat mass. In excess, leptin activates neurohormonal and sympathetic pathways that result in hyperaldosteronism, perpetuating sodium retention and PV expansion in HFpEF. This leads to distinct echocardiographic and hemodynamic changes reflecting increased cardiac volumes and pressures. Compared to those without obesity, patients with obesity and HFpEF have greater left atrial (LA) dilatation, greater concentric left ventricular (LV) remodeling, greater right ventricular (RV) dysfunction, and elevated resting and exercise intracardiac filling pressures.
Preliminary data from secondary analyses of randomized trial data have shown significant reductions in estimated PV in patients on treatment tirzepatide compared to placebo. These changes were associated with improvements in end organ function, functional capacity, and quality of life. Notably, prediction equations to estimate PV are inaccurate, demonstrating weak correlation with the gold standard dilution technique with radiolabeled iodinated serum albumin. Measuring changes in PV with this method would establish an important mechanism of clinical benefit in this population.
In addition, to further understand this mechanism and inform disease pathophysiology, it is also imperative to understand changes in body composition that occur with incretin-based therapies. 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. The investigators will leverage this technology to demonstrate the association between reductions in fat mass and serum leptin with PV reduction, representing a key pathway in the pathophysiology of obesity and HFpEF. In addition, the impact of incretin mimetics on lean mass in patients with obesity and HFpEF is important to establish given the association between lean mass reduction with sarcopenia and poor outcomes in HFpEF, especially in older adults. Due to biased assessment techniques, prior studies have demonstrated highly variable effects on lean mass.
The following are the Specific Aims of the study:
Specific Aim 1: To measure changes in PV in patients with obesity and HFpEF treated with tirzepatide. Hypothesis 1: Tirzepatide treatment will result in significant reduction in measured PV assessed using the gold standard indicator tracer dilution technique with 131-iodine-labeled albumin.
Specific Aim 2: To elucidate the relationship between changes in fat mass, serum adipokine profile, and PV in patients with obesity and HFpEF on tirzepatide treatment. Hypothesis 2: Reductions in QMR-estimated fat mass and reduction in serum leptin will be associated with significant reduction in measured PV.
Specific Aim 3: To quantify changes in lean mass in patients with obesity and HFpEF on tirzepatide treatment. Hypothesis 3: Treatment with tirzepatide will be associated with significant reduction in lean mass over time estimated with QMR.
Exploratory aim: To determine the impact of measured PV reduction on cardiac structure and quality of life in patients with obesity and HFpEF on tirzepatide therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tirzepatide
Glucagon-like 1 receptor agonist/glucose-dependent insulinotropic polypeptide receptor agonist
Also known as: Mounjaro
Plasma volume
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.
Time frame: 12 months
Fat mass
Body composition analysis will be performed with quantitative magnetic resonance (QMR). QMR will be performed early morning in a fasting state with participants in uniform hospital gowns and socks. Briefly, the QMR system generates a signal that modifies the spin of hydrogen atoms and uses an algorithm to evaluate the resulting T1 and T2 relaxation curves specific to one of the components of body composition: fat mass, fat-free mass, total body water. This will be performed at serial visits to determine the effect of tirzepatide therapy on fat mass over time.
Time frame: 12 months
Lean mass
Body composition analysis will be performed with QMR. QMR will be performed early morning in a fasting state with participants in uniform hospital gowns and socks. Briefly, the QMR system generates a signal that modifies the spin of hydrogen atoms and uses an algorithm to evaluate the resulting T1 and T2 relaxation curves specific to one of the components of body composition: fat mass, fat-free mass, total body water. This will be performed at serial visits to determine the effect of tirzepatide therapy on lean mass over time.
Time frame: 12 months
Change in total body water
Body composition analysis will be performed with QMR. QMR will be performed early morning in a fasting state with participants in uniform hospital gowns and socks. Briefly, the QMR system generates a signal that modifies the spin of hydrogen atoms and uses an algorithm to evaluate the resulting T1 and T2 relaxation curves specific to one of the components of body composition: fat mass, fat-free mass, total body water. This will be performed at serial visits to determine the effect of tirzepatide therapy on total body water over time.
Time frame: 12 months
Change in serum leptin
Leptin is a hormone associated with fat mass. Serum leptin will be measured serially on tirzepatide therapy to determine if reductions in serum leptin are associated with reduced plasma volume.
Time frame: 12 months
Change in serum adiponectin
Adiponectin is an adipokine that is inversely associated with fat mass. Serum adiponectin will be measured serially on tirzepatide therapy to determine if increases in serum adiponectin are associated with reduced plasma volume.
Time frame: 12 months
Change in KCCQ clinical summary score
The Kansas City Cardiomyopathy Questionnaire (KCCQ) evaluates health status from several principal domains including physical function, social function, symptoms and quality of life. Higher scores indicate better health status, ranging from 0 to 100 points. The clinical summary score will be the exploratory endpoint of interest.
Time frame: 12 months
Change in left atrial volume
Transthoracic echocardiograms will be performed at the baseline and final study visits. Change in left atrial volume will be exploratory end point of interest.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Apr 2029, 32 months after the start.
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Studies of the drug tested here: Tirzepatide