Heart Failure With Preserved Ejection Fraction (HFPEF)NCT06930495
The Effect of Adiposity on Muscle and Microvascular Function in HFpEF
An observational study of Heart Failure With Preserved Ejection Fraction (HFPEF), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFPEF)
- What is being tested?
- Weight loss SOC Treatment with second generation anti-diabetic medications
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2024to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: Patients with HFpEF - UTSW HFpEF clinic: lead by Dr. Ambarish Pandey Group 2: non-HFpEF controls * subjects in the UTSW volunteer research registry who meet inclusion/exclusion criteria * community outreach (emailers, word of mouth, referrals)
Who may be able to join
- 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
Show all 11Show fewer
- ≥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 join
- 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
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
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
Read more
- Define the mechanisms by which adiposity impairs exercise hemodynamics, microvascular function, and oxygen transport/utilization in patients with HFpEF.
- Determine if intensive medically directed weight loss can reduce microvascular inflammation and normalize exercise hemodynamics.
- Quantify the effect of medically directed weight loss on skeletal muscle function and catabolism.
Hypotheses
- Perfusion of subcutaneous adipose tissue disrupts blood flow distribution and impairs muscle microvascular perfusion and exercise hemodynamics.
- 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,
- Intensive weight loss will improve exercise hemodynamics, microvascular perfusion, and reduce muscular inflammation, and resistance training will augment these effects.
Read the 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
- Being tested
- Weight loss SOC Treatment with second generation anti-diabetic medications
- Keywords
- HFpEF, Weight loss, adiposity, inflammation, RNA sequencing, skeletal muscle
- Medical subject headings
- Weight Loss, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss SOC Treatment with second generation anti-diabetic medicationsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Weight loss SOC Treatment with second generation anti-diabetic medications | |
| Control Group (Non-HFpEF and Obesity) | Controls matched for age and hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak muscle perfusion during exercise
Peak muscle perfusion (Aβ) during exercise will be assessed by Contrast enhanced ultrasound (CEU)
Measured: Pre intervention (Day 1)
Peak muscle perfusion during exercise
Peak muscle perfusion (Aβ) during exercise will be assessed by Contrast enhanced ultrasound (CEU)
Measured: Post intervention (Post Day 1)
Single cell RNA sequencing of skeletal muscle
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
Measured: Pre intervention (Day 2)
Single cell RNA sequencing of skeletal muscle
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
Measured: Post intervention (Day 2)
Muscle to fat ratio of leg
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)
Measured: Pre intervention (Day 3)
Peak change in microvascular perfusion from rest to exercise
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
Measured: Pre intervention (Day 3)
Muscle to fat ratio of leg
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
Measured: Post intervention (Day 3)
Peak change in microvascular perfusion from rest to exercise
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
Measured: Post intervention (Day 3)
Secondary outcomes (12)
Vascular function - endothelium dependent vasodilation
A small ultrasound probe will be placed over the brachial artery and a small blood pressure cuff will be positioned on the lower arm, just below the elbow. Images of the vessel will be continuously recorded for 1 min (baseline) before the cuff is inflated to a high pressure (220mmHg) for 5minutes and immediately after the cuff is deflated for 3 minutes. The change in brachial artery diameter following deflation of cuff from baseline will represent a marker of vascular function
Measured: Pre intervention (Day1)
Vascular function - endothelium dependent vasodilation
A small ultrasound probe will be placed over the brachial artery and a small blood pressure cuff will be positioned on the lower arm, just below the elbow. Images of the vessel will be continuously recorded for 1 min (baseline) before the cuff is inflated to a high pressure (220mmHg) for 5minutes and immediately after the cuff is deflated for 3 minutes. The change in brachial artery diameter following deflation of cuff from baseline will represent a marker of vascular function
Measured: Post intervention (Day 1)
Blood volume measurement
The carbon monoxide rebreathe technique will be performed to measure blood volume
Measured: Pre intervention (Day1)
Blood volume measurement
The carbon monoxide rebreathe technique will be performed to measure blood volume
Measured: Post intervention (Day 1)
2min walk endurance test
Participants will be asked to walk on a flat surface back and forth between 2 cones for 2minutes. the total distance covered (in meters) during the 2-minutes will be recorded as a marker of endurance
Measured: Pre intervention (Day 2)
Hand grip strength
Participants will squeeze a handheld dynamometer as hard as they can to measure handgrip strength (in kg). This will be performed on both hands
Measured: Pre intervention (Day 2)
2min walk endurance test
Participants will be asked to walk on a flat surface back and forth between 2 cones for 2minutes. the total distance covered (in meters) during the 2-minutes will be recorded as a marker of endurance
Measured: Post intervention (Day2)
Hand grip strength
Participants will squeeze a handheld dynamometer as hard as they can to measure handgrip strength (in kg). This will be performed on both hands
Measured: Post intervention (Day2)
Body composition
measured using dual xray absorptiometry (DEXA) to get lean mass, muscle mass, body fat percentage
Measured: Pre intervention (Day 0)
Body composition
measured using dual xray absorptiometry (DEXA) to get lean mass, muscle mass, body fat percentage
Measured: Post intervention (Day 1)
Apnea hypopnea index
Participants will be given an at home sleep apnea test that is incorporated into a wrist-based wearable that enables non-invasive tracking of sleep apnea burden.
Sleep apnea will be determined from the apnea hypopnea index measured by the device. Apnea hypopnea index will be calculated as the average number of apneas or hypopneas that occurs per hour of sleep
Measured: Pre intervention (Day 2)
Apnea hypopnea index
Participants will be given an at home sleep apnea test that is incorporated into a wrist-based wearable that enables non-invasive tracking of sleep apnea burden.
Sleep apnea will be determined from the apnea hypopnea index measured by the device. Apnea hypopnea index will be calculated as the average number of apneas or hypopneas that occurs per hour of sleep
Measured: Post intervention (Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start10 Dec 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFPEF)Studies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Hearon, University of Texas Southwestern Medical Center
- Investigators
- Christopher M Hearon Jr, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930495
- Sponsor's protocol ID
- STU-2024-0279
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adiposity on Muscle and Microvascular Function in HFpEF
- ClinicalTrials.gov ID
- NCT06930495
- Acronym / sponsor ID
- STU-2024-0279
- Keywords
- HFpEF, Weight loss, adiposity, inflammation, RNA sequencing, skeletal muscle
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Define the mechanisms by which adiposity impairs exercise hemodynamics, microvascular function, and oxygen transport/utilization in patients with HFpEF.
- Determine if intensive medically directed weight loss can reduce microvascular inflammation and normalize exercise hemodynamics.
- Quantify the effect of medically directed weight loss on skeletal muscle function and catabolism.
Hypotheses
- Perfusion of subcutaneous adipose tissue disrupts blood flow distribution and impairs muscle microvascular perfusion and exercise hemodynamics.
- 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,
- Intensive weight loss will improve exercise hemodynamics, microvascular perfusion, and reduce muscular inflammation, and resistance training will augment these effects.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFpEF and Obesity Group | – | Drug: Weight loss SOC Treatment with second generation anti-diabetic medicationsPatients 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. |
| Control Group (Non-HFpEF and Obesity) | – | –Controls matched for age and hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: Patients with HFpEF - UTSW HFpEF clinic: lead by Dr. Ambarish Pandey Group 2: non-HFpEF controls * subjects in the UTSW volunteer research registry who meet inclusion/exclusion criteria * community outreach (emailers, word of mouth, referrals)
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (25 listed)
- Group 1
- Prior history of reduced ejection fraction (<50%)
- Infiltrative cardiomyopathy
- NYHA Class IV chronic heart failure
- Left bundle branch block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss SOC Treatment with second generation anti-diabetic medicationsTo 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. | Drug | HFpEF and Obesity Group |
Primary outcome
Peak muscle perfusion during exercise
Time frame: Pre intervention (Day 1)
Peak muscle perfusion (Aβ) during exercise will be assessed by Contrast enhanced ultrasound (CEU)
Peak muscle perfusion during exercise
Time frame: Post intervention (Post Day 1)
Peak muscle perfusion (Aβ) during exercise will be assessed by Contrast enhanced ultrasound (CEU)
Single cell RNA sequencing of skeletal muscle
Time frame: Pre 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 muscle
Time frame: Post 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 leg
Time frame: Pre 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 exercise
Time frame: Pre 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 leg
Time frame: Post 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 exercise
Time frame: Post 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
12 secondary outcomes
Vascular function - endothelium dependent vasodilation
Time frame: Pre intervention (Day1)
Vascular function - endothelium dependent vasodilation
Time frame: Post intervention (Day 1)
Blood volume measurement
Time frame: Pre intervention (Day1)
Blood volume measurement
Time frame: Post intervention (Day 1)
2min walk endurance test
Time frame: Pre intervention (Day 2)
Hand grip strength
Time frame: Pre intervention (Day 2)
2min walk endurance test
Time frame: Post intervention (Day2)
Hand grip strength
Time frame: Post intervention (Day2)
Body composition
Time frame: Pre intervention (Day 0)
Body composition
Time frame: Post intervention (Day 1)
Apnea hypopnea index
Time frame: Pre intervention (Day 2)
Apnea hypopnea index
Time frame: Post intervention (Day 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher M Hearon Jr, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction (HFPEF), run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak muscle perfusion during exercise (time frame: Pre intervention (Day 1)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.