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Recruiting NCT05115890

Muscle Blood Flow Regulation in HFpEF

No phase Interventional HFpEF

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise training.
Who it may be relevant to
Registry conditions: HFpEF. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Other Exercise training
    Patients with HFpEF will undergo 8 weeks of exercise training.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City

Identifiers

NCT: NCT05115890 · F3670-W

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗