Exercise + BH4 for Heart Failure
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, it mentions that participants should have been on optimal heart failure treatment, including certain medications, for at least 6 weeks before joining. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of this treatment for heart failure?
Is exercise training safe for heart failure patients?
How does the treatment Exercise training differ from other treatments for heart failure?
Exercise training for heart failure is unique because it focuses on improving physical fitness through supervised activities like endurance and resistance exercises, which can start in the hospital and continue at home. Unlike medications, this treatment enhances blood flow, muscle function, and quality of life without directly altering heart function, and it can be as effective as the best drug treatments in improving exercise capacity.4891011
Research Team
David W. Wray, PhD
Principal Investigator
VA Salt Lake City Health Care System, Salt Lake City, UT
Eligibility Criteria
This trial is for stable cardiomyopathy patients aged 45-75 who've been on optimal heart failure treatment for at least 6 weeks. They should have severe heart function reduction, minimal smoking history, and be able to exercise without orthopedic limits. Excluded are those with extreme obesity, uncontrolled high blood pressure, severe kidney issues, sedentary lifestyle, certain heart rhythm problems or diseases causing their heart failure.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo 8 weeks of oral antioxidant treatment, oral tetrahydrobiopterin treatment, or knee-extensor exercise training
Rehabilitation
Participants engage in an 8-week clinical cardiac rehabilitation program to assess adherence improvements
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Antioxidant
- Exercise training
- Tetrahydrobiopterin (BH4)
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
University of Utah
Collaborator