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Studies how body fat affects muscle and blood vessels in heart failure patients

Studies how weight loss medicine affects muscle and blood flow in adults with heart failure.

Key facts

Who runs it
University of Texas Southwestern Medical Center
Where
Dallas, United StatesSee the site
Trial code
Registry title
The Effect of Adiposity on Muscle and Microvascular Function in HFpEF
Status
Enrolling by invitation
People taking part
95 people, planned
Started
10 Dec 2024
Expected to end
1 Jun 2028
Type of study
Observational, 2 groups
Treatments tested
  • Weight loss SOC Treatment with second generation anti-diabetic medications
Record updated
3 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with heart failure with preserved ejection fraction (HFpEF) and obesity who will start weight loss medication as part of their usual care. It also includes adults without HFpEF as controls.

Age
Patients with HFpEF: 45 years or older. Controls without HFpEF: 18 years or older.
Sex
All sexes can join.
Disease stage
Patients with HFpEF need a heart failure diagnosis or a clear hospital stay for heart failure, a stable ejection fraction above 0.50, and proof of raised filling pressure in the left side of the heart. BMI above 32kg/m2.
Earlier treatment
Patients with HFpEF must not have taken incretin drugs for 6 months and must be candidates for incretin-based weight loss treatment as part of their usual care.
Biomarker or test result
Patients with HFpEF need a pulmonary capillary wedge pressure of 25 mmHg or more during supine exercise testing, or a rise of more than 15 mmHg during upright exercise.

Main reasons for not taking part

  • Earlier reduced ejection fraction (below 50%), or infiltrative cardiomyopathy
  • NYHA Class IV heart failure, left bundle branch block, unstable coronary artery disease, or uncontrolled arrhythmia
  • Severe valve disease, or CKD 4 or higher
  • Currently taking incretin-based drugs (SGL2, GLP1), or BMI above 50 kg/m2
  • Any reason that rules out MRI or muscle biopsies

The registry criteria, word for word

Show all 34 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Currently taking incretin-based drugs (SGL2, GLP1)
  • PDE5 inhibitor use
  • Currently taking incretin-based drugs (SGL2, GLP1)
  • 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
  • Prior history of reduced ejection fraction (<50%)
  • Age < 18 years
  • 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

Where in United States

  • University of Texas Southwestern Medical CenterDallas, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • HFpEF and Obesity Group

    Patients with HFpEF (heart failure with preserved ejection fraction) and diabetes will undergo standard of care treatment using the most appropriate second-generation anti-diabetic drug that induces clinically significant weight loss after completing baseline (pre) testing.

    Treatment: Weight loss SOC Treatment with second generation anti-diabetic medications

  • Control Group (Non-HFpEF and Obesity)

    Controls matched for age and hypertension

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Effect of Adiposity on Muscle and Microvascular Function in HFpEF
Plain-language title
Studies how body fat affects muscle and blood vessels in heart failure patientsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 September 2026