NCT04506606

Brief Summary

This research in Veterans with heart failure with preserved ejection fraction (HFpEF) will provide new information on the mechanisms determining the patients' exercise intolerance and the efficacy of regular physical activity to improve this shortcoming by alleviating the patients' neurocirculatory abnormalities. Specifically, the investigators will focus on the role of nerves originating in working limb muscles in determining the patients' exercise intolerance and compromised fatigue resistance before and after a chronic exercise intervention. By focusing on a specific mechanism, this project will evaluate the validity of exercise as an alternative treatment strategy with the overall purpose of improving the quality of life of Veterans with HFpEF.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
May 2022Sep 2026

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 2, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

August 6, 2020

Last Update Submit

March 16, 2026

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • femoral blood flow

    Quantifying femoral blood flow during exercise with and without afferent blockade

    1 hour

Secondary Outcomes (1)

  • femoral blood flow

    12 weeks

Study Arms (3)

Afferent effect on hemodynamics

EXPERIMENTAL

Evaluate impact of group III/IV muscle afferents on femoral blood flow

Procedure: Afferent block

Afferent effect on fatigue

EXPERIMENTAL

Evaluate impact of group III/IV muscle afferents on exercise-induced changes in quadriceps twitch force

Procedure: Afferent block

Effect of cardiac rehab

EXPERIMENTAL

Evaluate effect of chronic exercise on influence of muscle afferents on limb blood flow

Procedure: Afferent block

Interventions

Afferent blockPROCEDURE

Block sensory feedback to evaluate hemodynamic and fatigue consequence of group III/IV muscle afferents

Afferent effect on fatigueAfferent effect on hemodynamicsEffect of cardiac rehab

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • heart failure with preserved ejection fraction

You may not qualify if:

  • heart failure with reduced ejection fraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

Location

Study Officials

  • Markus Amann, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 10, 2020

Study Start

May 2, 2022

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)