NCT05115890 · VA Office of Research and Development
Muscle Blood Flow Regulation in HFpEF
What this study is about
Heart failure with preserved ejection (HFpEF) disproportionately affects Veterans and is the number one reason for hospital discharge in the VA Health Care System. Exercise intolerance is a common complication experienced by patients with HFpEF, perpetuating physical inactivity and accelerating disease progression.
View original scientific description
Heart failure with preserved ejection (HFpEF) disproportionately affects Veterans and is the number one reason for hospital discharge in the VA Health Care System. Exercise intolerance is a common complication experienced by patients with HFpEF, perpetuating physical inactivity and accelerating disease progression. This research proposal aims to elucidate mechanisms responsible for inadequate skeletal muscle blood flow and exercise intolerance in patients with HFpEF compared with healthy controls as well as following 8 weeks of exercise training in patients with HFpEF only.
Interventions
OTHER
Exercise training
Patients with HFpEF will undergo 8 weeks of exercise training.
Primary outcome measures
Six-minute walk test
Time frame: Change from baseline six-minute walk test distance at 8 weeks
The six-minute walk test is used to measure distance covered during walking at a comfortable speed for six minutes
Muscle blood flow
Time frame: Change from baseline skeletal muscle blood flow at 8 weeks
Muscle blood flow will be assessed non-invasively via Doppler ultrasound
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 years or older and able to give written informed consent
- New York Heart Association (NYHA) functional class II or III
- Left Ventricular Ejection Fraction (LVEF) \> 50%
- Plasma Brain Natriuretic Peptide (BNP) \>200 pg/mL or NT-proBNP 400 pg/mL at enrollment
Exclusion criteria
- Prior EF of \<50%.
- NYHA Class IV or HF that cannot be stabilized on optimized pharmacotherapy
- Acute coronary syndrome, infiltrative cardiomyopathy, or myocarditis
- Patients with HFpEF secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction)
- Orthopedic limitations that would prohibit knee-extensor exercise
- Women currently taking hormone replacement therapy (HRT) will be excluded from the proposed studies due to the direct vascular effects of HRT
- Women who are pregnant or may become pregnant, but the typical age of female patients with HFpEF will be postmenopausal
- Current smokers
Where
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations