RECRUITING

The Effect of Adiposity on Muscle and Microvascular Function in HFpEF

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effect of Adiposity on Muscle and Microvascular Function in HFpEF

Quick Facts

Study Start:2025-04-15
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06930495

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of heart failure or clear heart failure hospitalization
  2. * Stable ejection fraction \> 0.50
  3. * 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
  4. * Must be candidates for pharmacological incretin-based directed intensive weight loss therapies as part of their SOC
  5. * BMI\>32kg/m2
  6. * ≥45 years old
  7. * Incretin naïve for 6 months
  8. * Adults who do not have heart failure with preserved ejection fraction
  9. * Age ≥ 18 years
  1. * Prior history of reduced ejection fraction (\<50%)
  2. * Infiltrative cardiomyopathy
  3. * NYHA Class IV chronic heart failure
  4. * Left bundle branch block
  5. * Unstable coronary artery disease
  6. * Uncontrolled arrhythmia
  7. * CKD 4 or higher
  8. * Currently taking incretin-based drugs (SGL2, GLP1)
  9. * Severe valvular heart disease
  10. * BMI \> 50kg/m2
  11. * Other debilitating illness that would preclude participation
  12. * Any contra-indication to MRI
  13. * Any contra-indication to muscle biopsies.
  14. * Age \< 18 years
  15. * BMI \> 50 kg/m2
  16. * Atrial fibrillation with poorly controlled heart rate
  17. * PDE5 inhibitor use
  18. * Severe valvular disease
  19. * Severe COPD
  20. * CKD 4 or higher
  21. * Currently taking incretin-based drugs (SGL2, GLP1)
  22. * Any contra-indication to MRI
  23. * Any contra-indication to muscle biopsies.

Contacts and Locations

Study Contact

Sarah L Hissen, PhD
CONTACT
214-345-8841
sarah.hissen@utsouthwestern.edu
Christopher M Hearon Jr, PhD
CONTACT
214-345--4624
christopher.hearon@utsouthwestern.edu

Principal Investigator

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

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-15
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2025-04-15
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • HFpEF
  • Weight loss
  • adiposity
  • inflammation
  • RNA sequencing
  • skeletal muscle

Additional Relevant MeSH Terms

  • Heart Failure With Preserved Ejection Fraction (HFPEF)