Status:
RECRUITING
The Effect of Adiposity on Muscle and Microvascular Function in HFpEF
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Heart Failure With Preserved Ejection Fraction (HFPEF)
Eligibility:
All Genders
18+ years
Brief Summary
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 diabete...
Detailed Description
Objective one will also include a cross-sectional comparison between HFpEF patients before treatment and non-HFpEF controls matched for age and hypertension
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06930495
Start Date
December 10 2024
End Date
June 1 2026
Last Update
July 31 2025
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390