Impact of obesity on heart function in patients with heart failure
The Effect of Adiposity on Muscle and Microvascular Function in HFpEF
This study is testing how extra body fat affects heart function in people with heart failure and whether losing weight can help them feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06930495 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how excess body fat affects muscle and microvascular function in patients with heart failure with preserved ejection fraction (HFpEF). Participants will undergo multiple assessments before and after a medically directed weight loss intervention, aiming for at least a 7% reduction in body weight over 9-12 months. The study seeks to understand the mechanisms by which adiposity impairs exercise capacity and cardiovascular health, and whether weight loss can improve these outcomes. Additionally, a comparison will be made between HFpEF patients and non-HFpEF controls to further elucidate these effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 45 and older with a diagnosis of HFpEF and a BMI greater than 32 kg/m2 who are eligible for weight loss medications.
Not a fit: Patients with a history of reduced ejection fraction, severe heart failure, or other significant cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with HFpEF, enhancing their exercise tolerance and overall cardiovascular health.
How similar studies have performed: Other studies have shown promising results in weight loss interventions for heart failure patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Group 1: Patients with HFpEF * Diagnosis of heart failure or clear heart failure hospitalization * Stable ejection fraction \> 0.50 * Objective evidence of elevated left ventricular filling pressure by one of the following i) pulmonary capillary wedge pressure ≥25 mmHg during supine cardiopulmonary exercise testing or ii) a change in pulmonary capillary wedge pressure of \>15 mmHg during upright exercise * Must be candidates for pharmacological incretin-based directed intensive weight loss therapies as part of their SOC * BMI\>32kg/m2 * ≥45 years old * Incretin naïve for 6 months Group 2: Non-HFpEF controls * Adults who do not have heart failure with preserved ejection fraction * Age ≥ 18 years Exclusion Criteria: Group 1 * Prior history of reduced ejection fraction (\<50%) * Infiltrative cardiomyopathy * NYHA Class IV chronic heart failure * Left bundle branch block * Unstable coronary artery disease * Uncontrolled arrhythmia * CKD 4 or higher * Currently taking incretin-based drugs (SGL2, GLP1) * Severe valvular heart disease * BMI \> 50kg/m2 * Other debilitating illness that would preclude participation * Any contra-indication to MRI * Any contra-indication to muscle biopsies. Group 2 * Age \< 18 years * BMI \> 50 kg/m2 * Atrial fibrillation with poorly controlled heart rate * PDE5 inhibitor use * Severe valvular disease * Severe COPD * CKD 4 or higher * Currently taking incretin-based drugs (SGL2, GLP1) * Any contra-indication to MRI * Any contra-indication to muscle biopsies.
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Christopher M Hearon Jr, PhD — University of Texas Southwestern Medical Center
- Study coordinator: Sarah L Hissen, PhD
- Email: sarah.hissen@utsouthwestern.edu
- Phone: 214-345-8841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.