RecruitingNot Applicable

Muscle Blood Flow Regulation in HFpEF

United States35 participantsStarted 2022-07-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Six-minute walk test

Timeframe: Change from baseline six-minute walk test distance at 8 weeks

Muscle blood flow

Timeframe: Change from baseline skeletal muscle blood flow at 8 weeks

Trial details

NCT IDNCT05115890

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Kanokwan Bunsawat, PhD

(801) 582-1565 Kanokwan.Bunsawat@va.gov

View on ClinicalTrials.gov More HFpEF trials