HFpEFNCT05115890
Muscle Blood Flow Regulation in HFpEF
A study testing Exercise training in people with HFpEF, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HFpEF
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 29 Feb 2028
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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
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, 1 recruiting
- Recruiting
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
Kanokwan Bunsawat, PhD, 801-582-1565 ext. 1951, Kanokwan.Bunsawat@va.gov
David W Wray, PhD, (801) 582-1565 ext. 4162, David.Wray2@va.gov
About this study
Official title: Mechanisms of Impaired Skeletal Muscle Blood Flow and Exercise Intolerance in Veterans With Heart Failure With Preserved Ejection Fraction: Efficacy of Knee Extensor Training
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.
Read the detailed description
Heart failure (HF) with preserved ejection fraction (HFpEF) disproportionately afflicts Veterans and is the leading cause of hospitalization and mortality within the VA Health Care System. One chief symptom of HFpEF is severe exercise intolerance, an important predictor of quality of life, functional capacity, and mortality. In these patients, severe exercise intolerance is attributable to a disease-related loss of "peripheral vascular control," as evidenced by a marked attenuation in exercising skeletal muscle blood flow. Loss of peripheral vascular control is manifested as dysfunctions of the autonomic nervous system (ANS) and vasodilatory ability of the microvasculature, thereby restraining skeletal muscle blood flow and O2 delivery and limiting the capacity for sustained physical activity. This research proposal aims to elucidate peripheral vascular control mechanisms responsible for inadequate skeletal muscle blood flow and exercise intolerance in patients with HFpEF. In addition, there is some indication that aerobic exercise training may improve peripheral vascular function in HFpEF , though the mechanisms have yet to be elucidated. Thus, an additional aim of this research proposal is to evaluate peripheral vascular control mechanisms of skeletal muscle blood flow and exercise tolerance following 8 weeks of exercise training in patients with HFpEF. To test this, the initial phase will involve a cross-sectional comparison of patients with HFpEF (n=35) and age and sex-matched healthy controls (n=35), followed by an interventional phase where only patients with HFpEF will enter 8 weeks of exercise training. It is anticipated that knowledge gained will (a) improve the understanding of HFpEF pathophysiology and (b) determine the efficacy of a unique exercise training modality to restore functional capacity and exercise tolerance in patients with HFpEF.
- Conditions
- HFpEF
- Being tested
- Exercise training
- Keywords
- HFpEF, Muscle Blood Flow, Exercise Tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Patients with HFpEF will undergo 8 weeks of exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Patients with HFpEF will participate in the 8 weeks of supervised, two-legged, knee extensor exercise training for 3 days per week. Each exercise session will involve a 5-min warm-up and a 5-min cool-down, and exercise intensity will range between 40%-90% of maximal work rate. Maximal work rate will be re-assessed every two weeks. Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test
The six-minute walk test is used to measure distance covered during walking at a comfortable speed for six minutes
Measured: Change from baseline six-minute walk test distance at 8 weeks
Muscle blood flow
Muscle blood flow will be assessed non-invasively via Doppler ultrasound
Measured: Change from baseline skeletal muscle blood flow at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Jul 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFpEFStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with HFpEF assigned to 8 weeks of exercise training
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kanokwan Bunsawat, PhD, Principal investigator, VA Salt Lake City Health Care System, Salt Lake City, UT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115890
- Sponsor's protocol ID
- F3670-W
- Status last verified
- Apr 2026
- First submitted
- 21 Oct 2021
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Impaired Skeletal Muscle Blood Flow and Exercise Intolerance in Veterans With Heart Failure With Preserved Ejection Fraction: Efficacy of Knee Extensor Training
- ClinicalTrials.gov ID
- NCT05115890
- Acronym / sponsor ID
- F3670-W
- Conditions
- HFpEF
- Keywords
- HFpEF, Muscle Blood Flow, Exercise Tolerance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 10 Nov 2021 (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.
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.
Detailed description
Heart failure (HF) with preserved ejection fraction (HFpEF) disproportionately afflicts Veterans and is the leading cause of hospitalization and mortality within the VA Health Care System. One chief symptom of HFpEF is severe exercise intolerance, an important predictor of quality of life, functional capacity, and mortality. In these patients, severe exercise intolerance is attributable to a disease-related loss of "peripheral vascular control," as evidenced by a marked attenuation in exercising skeletal muscle blood flow. Loss of peripheral vascular control is manifested as dysfunctions of the autonomic nervous system (ANS) and vasodilatory ability of the microvasculature, thereby restraining skeletal muscle blood flow and O2 delivery and limiting the capacity for sustained physical activity. This research proposal aims to elucidate peripheral vascular control mechanisms responsible for inadequate skeletal muscle blood flow and exercise intolerance in patients with HFpEF. In addition, there is some indication that aerobic exercise training may improve peripheral vascular function in HFpEF , though the mechanisms have yet to be elucidated. Thus, an additional aim of this research proposal is to evaluate peripheral vascular control mechanisms of skeletal muscle blood flow and exercise tolerance following 8 weeks of exercise training in patients with HFpEF. To test this, the initial phase will involve a cross-sectional comparison of patients with HFpEF (n=35) and age and sex-matched healthy controls (n=35), followed by an interventional phase where only patients with HFpEF will enter 8 weeks of exercise training. It is anticipated that knowledge gained will (a) improve the understanding of HFpEF pathophysiology and (b) determine the efficacy of a unique exercise training modality to restore functional capacity and exercise tolerance in patients with HFpEF.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with HFpEF assigned to 8 weeks of exercise training
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Exercise trainingPatients with HFpEF will participate in the 8 weeks of supervised, two-legged, knee extensor exercise training for 3 days per week. Each exercise session will involve a 5-min warm-up and a 5-min cool-down, and exercise intensity will range between 40%-90% of maximal work rate. Maximal work rate will be re-assessed every two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Exercise trainingPatients with HFpEF will undergo 8 weeks of exercise training. | Other | Exercise training |
Primary outcome
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
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 21 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for HFpEF
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
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.
Kanokwan Bunsawat, PhD principal investigator
VA Salt Lake City Health Care System, Salt Lake City, UT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with HFpEF, run by VA Office of Research and Development 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 21 Apr 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?
Contact Kanokwan Bunsawat, PhD ((801) 582-1565 ext. 1951, Kanokwan.Bunsawat@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk test (time frame: Change from baseline six-minute walk test distance at 8 weeks). The study lists 2 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 21 Apr 2026.