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NCT06930495

The Effect of Adiposity on Muscle and Microvascular Function in HFpEF

Enrolling by Invitation
Not specifiedAges 18+Observational
University of Texas Southwestern Medical Center
~95 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:Weight loss SOC Treatment with second generation anti-diabetic medications

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak muscle perfusion during exercise
Measured over Pre intervention (Day 1)
+7 more outcomes measured

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Explore related trials

Heart failure with normal ejection fraction

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Christopher M Hearon Jr, PhD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Adults who do not have heart failure with preserved ejection fraction
Age ≥ 18 years

Exclusion

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.
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.

What this trial measures

  • Peak muscle perfusion during exercisePre intervention (Day 1)

    Peak muscle perfusion (Aβ) during exercise will be assessed by Contrast enhanced ultrasound (CEU)

  • Peak muscle perfusion during exercisePost intervention (Post Day 1)

    Peak muscle perfusion (Aβ) during exercise will be assessed by Contrast enhanced ultrasound (CEU)

  • Single cell RNA sequencing of skeletal musclePre intervention (Day 2)

    Skeletal muscle biopsies will be taken from the vastus lateralis using the modified Bergstrom technique and immediately prepared for single cell RNA sequencing. Samples will be digested, filtered, washed and resuspended in freezing media and checked for concentration and viability before single cell RNA sequencing is performed

  • Single cell RNA sequencing of skeletal musclePost intervention (Day 2)

    Skeletal muscle biopsies will be taken from the vastus lateralis using the modified Bergstrom technique and immediately prepared for single cell RNA sequencing. Samples will be digested, filtered, washed and resuspended in freezing media and checked for concentration and viability before single cell RNA sequencing is performed

  • Muscle to fat ratio of legPre intervention (Day 3)

    MRI of the leg will be performed to acquire clear visualization of fasciae separating different muscle groups and thus allowing for quantification of intermuscular fat (muscle:fat ratio)

  • Peak change in microvascular perfusion from rest to exercisePre intervention (Day 3)

    MRI of the leg will be performed utilizing the PIVOT sequence which will measure global and regional perfusion of blood to the muscles in the lower leg at rest and during exercise. the peak change will be reported as the change from baseline to peak exercise

  • Muscle to fat ratio of legPost intervention (Day 3)

    MRI of the leg will be performed utilizing the PIVOT sequence which will measure the change in perfusion of blood to the muscles in the lower leg from rest to during exercise

  • Peak change in microvascular perfusion from rest to exercisePost intervention (Day 3)

    MRI of the leg will be performed utilizing the PIVOT sequence which will measure global and regional perfusion of blood to the muscles in the lower leg at rest and during exercise. the peak change will be reported as the change from baseline to peak exercise