The Effect of Adiposity on Muscle and Microvascular Function in HFpEF
Study explores how weight loss impacts heart failure and muscle function
Plain English Summary
The Effect of Adiposity on Muscle and Microvascular Function in HFpEF is a Not Applicable clinical trial sponsored by University of Texas Southwestern Medical Center studying Heart Failure With Preserved Ejection Fraction (HFPEF). This study investigates how excess body fat and inflammation affect muscle and heart health in people with a specific type of heart failure (HFpEF). It is for individuals diagnosed with HFpEF who are candidates for weight loss medication to manage obesity or diabetes. Participants will have several visits before and after starting weight loss treatment (at least 7% weight loss over 9-12 months) for tests and monitoring. Alternatives include standard medical care for HFpEF and obesity/diabetes management, without the specific research assessments. The trial aims to enroll 95 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. To join, you must have HFpEF, a stable heart pumping function (ejection fraction >50%), and evidence of high pressure in your heart. You should be a candidate for weight loss medication and have a BMI over 32, and be at least 45 years old. You cannot have had heart failure with reduced pumping function in the past, certain heart conditions, severe kidney disease (stage 4+), or be currently taking specific diabetes/weight loss drugs (SGLT2, GLP1). Individuals with contraindications to MRI or muscle biopsies cannot participate. This trial is studying Heart Failure With Preserved Ejection Fraction (HFPEF), so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures, such as how well muscles get blood flow during exercise and the composition of muscle tissue, will show if weight loss helps improve the physical ability and health of mu The specific primary outcome measures are: Peak muscle perfusion during exercise (Pre intervention (Day 1)); Peak muscle perfusion during exercise (Post intervention (Post Day 1)); Single cell RNA sequencing of skeletal muscle (Pre intervention (Day 2)); Single cell RNA sequencing of skeletal muscle (Post intervention (Day 2)); Muscle to fat ratio of leg (Pre intervention (Day 3)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it aims to understand how medically supervised weight loss can improve exercise capacity and cardiovascular health in patients with HFpEF, a condition with limited trea This research targets Heart Failure With Preserved Ejection Fraction (HFPEF), where improved treatment options are needed.
Investor Insight
This observational study, focusing on a growing patient population with HFpEF and obesity, signals potential for new therapeutic insights into weight management's role in cardiovascular health, with i
Is This Trial Right for Me?
Ask your doctor if this study is right for you, especially regarding the weight loss medication and the research tests involved. Participation involves multiple clinic visits for tests like exercise assessments, blood draws, and potentially MRI scans and muscle biopsies. You will be receiving standard weight loss treatment as part of your regular care, with the study adding extra monitoring and assessments. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 95 participants
Interventions
- DRUG: Weight 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
Primary Outcomes
- Peak muscle perfusion during exercise (Pre intervention (Day 1))
- Peak muscle perfusion during exercise (Post intervention (Post Day 1))
- Single cell RNA sequencing of skeletal muscle (Pre intervention (Day 2))
- Single cell RNA sequencing of skeletal muscle (Post intervention (Day 2))
- Muscle to fat ratio of leg (Pre intervention (Day 3))
Secondary Outcomes
- Vascular function - endothelium dependent vasodilation (Pre intervention (Day1))
- Vascular function - endothelium dependent vasodilation (Post intervention (Day 1))
- Blood volume measurement (Pre intervention (Day1))
- Blood volume measurement (Post intervention (Day 1))
- 2min walk endurance test (Pre intervention (Day 2))
Trial Locations
- University of Texas Southwestern Medical Center, Dallas, Texas, United States
Frequently Asked Questions
What is clinical trial NCT06930495?
NCT06930495 is a Not Applicable OBSERVATIONAL study titled "The Effect of Adiposity on Muscle and Microvascular Function in HFpEF." It is currently enrolling by invitation and is sponsored by University of Texas Southwestern Medical Center. The trial targets enrollment of 95 participants.
What conditions does NCT06930495 study?
This trial investigates treatments for Heart Failure With Preserved Ejection Fraction (HFPEF). The primary condition under study is Heart Failure With Preserved Ejection Fraction (HFPEF).
What treatments are being tested in NCT06930495?
The interventions being studied include: Weight loss SOC Treatment with second generation anti-diabetic medications (DRUG). 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
What does Not Applicable mean for NCT06930495?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06930495?
This trial is currently "Enrolling by Invitation." It started on 2024-12-10. The estimated completion date is 2028-06-01.
Who is sponsoring NCT06930495?
NCT06930495 is sponsored by University of Texas Southwestern Medical Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06930495?
The trial aims to enroll 95 participants. The trial status is enrolling by invitation.
How is NCT06930495 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06930495?
The primary outcome measures are: Peak muscle perfusion during exercise (Pre intervention (Day 1)); Peak muscle perfusion during exercise (Post intervention (Post Day 1)); Single cell RNA sequencing of skeletal muscle (Pre intervention (Day 2)); Single cell RNA sequencing of skeletal muscle (Post intervention (Day 2)); Muscle to fat ratio of leg (Pre intervention (Day 3)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06930495 being conducted?
This trial is being conducted at 1 site, including Dallas, Texas (United States).
Where can I find official information about NCT06930495?
The official record for NCT06930495 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06930495. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06930495 testing in simple terms?
This study investigates how excess body fat and inflammation affect muscle and heart health in people with a specific type of heart failure (HFpEF). It is for individuals diagnosed with HFpEF who are candidates for weight loss medication to manage obesity or diabetes.
Why is this trial significant?
This trial is important because it aims to understand how medically supervised weight loss can improve exercise capacity and cardiovascular health in patients with HFpEF, a condition with limited trea
What are the potential risks of participating in NCT06930495?
Potential risks include those associated with the weight loss medication itself, such as nausea or digestive issues. There are also risks related to the study procedures, including discomfort or minor complications from blood draws, exercise tests, MRI scans, or muscle biopsies. Some participants might experience fatigue or muscle soreness after exercise tests or biopsies. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06930495?
Ask your doctor if this study is right for you, especially regarding the weight loss medication and the research tests involved. Participation involves multiple clinic visits for tests like exercise assessments, blood draws, and potentially MRI scans and muscle biopsies. You will be receiving standard weight loss treatment as part of your regular care, with the study adding extra monitoring and assessments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06930495 signal from an investment perspective?
This observational study, focusing on a growing patient population with HFpEF and obesity, signals potential for new therapeutic insights into weight management's role in cardiovascular health, with i This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will have several visits before and after starting weight loss treatment (at least 7% weight loss over 9-12 months) for tests and monitoring. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.