Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT05115890

Conditions

HFpEF

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Exercise training

Study Details

Brief 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.

Conditions

HFpEF

Study ID

NCT05115890

Start date

Jul 1, 2022

Status verified date

Apr, 2026

Completion date

Feb 29, 2028

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Exercise training

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.

Interventions

Exercise training

Patients with HFpEF will undergo 8 weeks of exercise training.

Primary outcome measure

  • Six-minute walk test [ Time Frame: Change from baseline six-minute walk test distance at 8 weeks ]
  • Muscle blood flow [ Time Frame: Change from baseline skeletal muscle blood flow at 8 weeks ]

Central Contacts and Locations

Central contacts

Kanokwan Bunsawat, PhD

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

David W Wray, PhD

(801) 582-1565David.Wray2@va.gov

Locations

VA Salt Lake City Health Care System, Salt Lake City, UT

Recruiting

Salt Lake City, Utah, United States, 84148-0001

Contacts

Kanokwan Bunsawat, PhD

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

David W Wray, PhD

(801) 582-1565David.Wray2@va.gov

Principal Investigator:

Kanokwan Bunsawat, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • HFpEF
  • Muscle Blood Flow
  • Exercise Tolerance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-21.