Muscle Blood Flow Regulation in HFpEF

NCT05115890 | Recruiting DMC

• 1 other identifier: F3670-W
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

HFpEF; Muscle Blood Flow; Exercise Tolerance

Outcome Measures

Primary Outcomes (2)

• Six-minute walk test

  The six-minute walk test is used to measure distance covered during walking at a comfortable speed for six minutes

  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

  Change from baseline skeletal muscle blood flow at 8 weeks

Study Arms (1)

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.

Other: Exercise training

Interventions

Exercise training OTHER

Patients with HFpEF will undergo 8 weeks of exercise training.

Exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

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

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kanokwan Bunsawat, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kanokwan Bunsawat, PhD

CONTACT

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

David W Wray, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Patients with HFpEF assigned to 8 weeks of exercise training

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 10, 2021
• Study Start: July 1, 2022
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)