140 Participants Needed

Exercise + BH4 for Heart Failure

RS
DW
Overseen ByDavid W Wray, PhD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: VA Office of Research and Development
Must be taking: Ace inhibitors, Beta blockers

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?

Research shows that exercise training can improve fitness levels, relieve symptoms, and potentially reduce hospitalizations and mortality in heart failure patients. Regular exercise is recommended for heart failure patients as it enhances quality of life and survival.12345

Is exercise training safe for heart failure patients?

Exercise training is generally considered safe for heart failure patients when they are properly evaluated and monitored. Studies suggest that it can be safely performed and may even improve fitness and symptoms in these patients.13467

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

DW

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

You can only join the study if you have specific heart symptoms, low heart function, hardly smoke, and do not have a pacemaker.
I am on heart failure treatment as per AHA/ACC/HFSA guidelines or have a valid reason for not following them.
I have had a stable heart condition for over 3 months, despite treatment.

Exclusion Criteria

My heart failure is not due to untreated major valve problems, except for issues caused by a weak left ventricle.
I am currently on hormone replacement therapy.
My heart condition is due to atrial fibrillation.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 weeks of oral antioxidant treatment, oral tetrahydrobiopterin treatment, or knee-extensor exercise training

8 weeks

Rehabilitation

Participants engage in an 8-week clinical cardiac rehabilitation program to assess adherence improvements

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Antioxidant
  • Exercise training
  • Tetrahydrobiopterin (BH4)
Trial OverviewThe study tests if antioxidants and a compound called Tetrahydrobiopterin (BH4), along with exercise training can improve muscle blood flow and exercise tolerance in people with reduced ejection fraction heart failure (HFrEF). The goal is to slow disease progression and enhance quality of life.
Participant Groups
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral BH4Experimental Treatment1 Intervention
8 week oral tetrahydrobiopterin treatment
Group II: Oral AOxExperimental Treatment1 Intervention
8 week oral antioxidant treatment
Group III: Ex trainingExperimental Treatment1 Intervention
8-week knee-extensor exercise training program
Group IV: Oral BH4 (placebo)Placebo Group1 Intervention
Placebo for arm 3
Group V: Oral AOx (placebo)Placebo Group1 Intervention
Placebo for arm 1
Group VI: Ex training (attn con)Placebo Group1 Intervention
Attention control for arm 5

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

University of Utah

Collaborator

Trials
1,169
Recruited
1,623,000+

Findings from Research

Exercise training is effective and safe for heart failure (HF) patients, improving their fitness levels and symptoms, and may even reduce mortality and morbidity.
The review supports prescribing exercise training for patients with NYHA functional classes II-III and suggests that stable NYHA IV patients who are asymptomatic at rest could also benefit from training.
Exercise training in patients with heart failure: clinical outcomes, safety, and indications.McKelvie, RS.[2021]
Regular exercise training significantly improves quality of life and survival rates in both healthy individuals and patients with cardiovascular diseases, including those with stable heart failure.
In patients with heart failure classified as NYHA functional classes II and III, exercise training alleviates symptoms, enhances exercise capacity, and may reduce hospitalizations and mortality, highlighting its importance as a recommended treatment.
Exercise training in chronic heart failure: mechanisms and therapies.Piepoli, MF.[2022]
In a study of 82 heart failure patients, those who participated in supervised hospital-based exercise training showed significant improvements in functional capacity, with peak oxygen consumption increasing from 19.4 to 21.4 mL/min/kg, while home-based training did not show similar benefits.
Quality of life also improved significantly in the hospital-based group, but there were no significant differences in cardiac events between the two groups after one year, suggesting that while hospital-based training is more effective for immediate functional improvements, both training types have similar long-term safety outcomes.
Comparison of Supervised Hospital-based versus Educated Home-based Exercise Training in Korean Heart Failure Patients.Kim, M., Kim, MS., Lim, SJ., et al.[2020]

References

Exercise training in patients with heart failure: clinical outcomes, safety, and indications. [2021]
Exercise training in chronic heart failure: mechanisms and therapies. [2022]
Comparison of Supervised Hospital-based versus Educated Home-based Exercise Training in Korean Heart Failure Patients. [2020]
How to do: telerehabilitation in heart failure patients. [2019]
Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. [2007]
Establishing a cardiac training group for patients with heart failure: the "HIP-in-Würzburg" study. [2022]
Safety and effects of physical training in chronic heart failure. Results of the Chronic Heart Failure and Graded Exercise study (CHANGE) [2007]
[Exercise Training and Physical Activity in Patients with Heart Failure]. [2018]
[Physical activity and training in heart failure]. [2019]
Effects of Concurrent, Within-Session, Aerobic and Resistance Exercise Training on Functional Capacity and Muscle Performance in Elderly Male Patients with Chronic Heart Failure. [2023]
Exercise training in heart failure. [2018]