MedTrace Logo

Exercise and NO in HFrEF

NCT03136029 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-08-06

No results posted yet for this study

Summary

Heart disease is the leading cause of death in the United States, accounting for one in every four deaths in 2010 and costing over $300 billion annually in health care, medication, and lost productivity. Heart failure with a reduced ejection fraction (HFrEF), a clinical syndrome that develops as a consequence of heart disease, now affects almost 6 million Americans. Within the VA Health Care System, HFrEF hospital admission rates continue to rise, and remain the number one reason for discharge from VA hospitals nationwide. Unfortunately, over one-third of all Veterans suffering from HFrEF die within two years of discharge despite optimized drug therapy, an unacceptably high number. This proposal is focused on how impaired muscle blood flow contributes to exercise intolerance in HFrEF, and on subsequently developing strategies for restoring exercise tolerance and slowing disease progression in this patient group. It is anticipated that knowledge gained from these studies will contribute to improved standard of care, quality of life, and prognosis in this VA patient group.

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

DIETARY_SUPPLEMENT

Antioxidant

Daily consumption of over-the-counter vitamins (600mg alpha lipoic acid, 1000mg vitamin c, 600IU vitamin E)

DIETARY_SUPPLEMENT

Tetrahydrobiopterin (BH4)

Daily consumption of BH4 (10mg/kg)

OTHER

Exercise training

Aerobic exercise training program (3x/week for 8 weeks, 1 hour per session)

Sponsors & Collaborators

Principal Investigators

  • David W. Wray, PhD · VA Salt Lake City Health Care System, Salt Lake City, UT

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2025-05-31
Completion
2025-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03136029 on ClinicalTrials.gov