NCT06930495Enrolling by invitation
The Effect of Adiposity on Muscle and Microvascular Function in HFpEF
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
This project is an observational study in patients with heart failure with preserved ejection fraction (HFpEF) who are candidates for treatment with weight loss medication to manage obesity or diabetes as part of their standard clinical care. This study will include multiple experimental visits before and after treatment (minimum 7 percent weight loss, between 9-12 months) to understand how increased adiposity and inflammation effects skeletal muscle and cardiovascular health and function and to examine the effect of medically directed weight loss on skeletal muscle health and exercise tolerance. The objective of this study is to 1. Define the mechanisms by which adiposity impairs exercise hemodynamics, microvascular function, and oxygen transport/utilization in patients with HFpEF. 2. Determine if intensive medically directed weight loss can reduce microvascular inflammation and normalize exercise hemodynamics. 3. Quantify the effect of medically directed weight loss on skeletal muscle function and catabolism. Hypotheses 1. Perfusion of subcutaneous adipose tissue disrupts blood flow distribution and impairs muscle microvascular perfusion and exercise hemodynamics. 2. Extramyocellular muscular lipid deposition and microvascular endothelial inflammation is associated with reduced capillarity and impaired microvascular perfusions, while intramyocellular triglyceride content is associated with poor skeletal muscle oxidative capacity, 3. Intensive weight loss will improve exercise hemodynamics, microvascular perfusion, and reduce muscular inflammation, and resistance training will augment these effects.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 95 (estimated)
- First submitted
- 31 Mar 2025
- Start date
- 10 Dec 2024
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Heart failure, Obesity
- NCT number
- NCT06930495
What you commit to
- Study type: Observational
- Planned participants: 95
- From 10 Dec 2024 to the primary completion date, 1 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking incretin-based drugs (SGL2, GLP1)
- PDE5 inhibitor use
- Currently taking incretin-based drugs (SGL2, GLP1)
Other illness
- NYHA Class IV chronic heart failure
- Unstable coronary artery disease
- Uncontrolled arrhythmia
- Severe valvular heart disease
- Other debilitating illness that would preclude participation
- Atrial fibrillation with poorly controlled heart rate
- Severe valvular disease
Lab values
- Prior history of reduced ejection fraction (\<50%)
Age
- Age \< 18 years
Other
- Group 1
- Infiltrative cardiomyopathy
- Left bundle branch block
- CKD 4 or higher
- BMI \> 50kg/m2
- Any contra-indication to MRI
- Any contra-indication to muscle biopsies.
- Group 2
- BMI \> 50 kg/m2
- Severe COPD
- CKD 4 or higher
- Any contra-indication to MRI
- Any contra-indication to muscle biopsies.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.