RecruitingNCT06930495

The Effect of Adiposity on Muscle and Microvascular Function in HFpEF


Sponsor

University of Texas Southwestern Medical Center

Enrollment

100 participants

Start Date

Dec 10, 2024

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines how excess body weight affects heart muscle and small blood vessel function in people who have heart failure with preserved ejection fraction (HFpEF) — a type of heart failure where the heart pumps normally but doesn't fill properly. It also tests whether weight loss medication (GLP-1/incretin-based drugs) improves these functions. **You may be eligible if...** - You have been diagnosed with HFpEF (Group 1) with a BMI over 32 and are 45 or older - OR you are an adult without heart failure (Group 2, control group, age 18 and older) - You have not used weight loss (incretin-based) medication in the past 6 months **You may NOT be eligible if...** - You have severely reduced heart function (ejection fraction below 50%) - You have NYHA Class IV heart failure (severe symptoms at rest) - You have severe kidney disease (CKD stage 4 or higher) - You are unable to have an MRI scan or muscle biopsy - You have a BMI greater than 50 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGWeight loss SOC Treatment with second generation anti-diabetic medications

To determine the best incretin-based drug for the treatment \[done as part of regular standard of care (SOC) treatment\], participants will go to UTSW weight wellness clinic and undergo a comprehensive history and physical exam to evaluate their overall health. This information is used to create an individualized approach to the participants weight loss regimen. As part of the regimen, participants will receive guidance on initiating lifestyle modifications including diet and exercise and may be referred to a clinical psychologist for evaluation and management of factors like stress, anxiety and depression, and exercise which may influence their health behaviors and body weight.


Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT06930495


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