Exercise + BH4 for Heart Failure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: VA Office of Research and Development
Must be taking: Ace inhibitors, Beta blockers
Must not be taking: Hormone replacement therapy
Disqualifiers: Atrial fibrillation, Dementia, COPD, Diabetes, others
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.
12345Is 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.
13467How 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.
4891011Eligibility 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.
+5 more
Trial 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
Participant Groups
The 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.
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
Research Locations NearbySelect from list below to view details:
VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake City, UT
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
University of UtahCollaborator
References
Exercise training in patients with heart failure: clinical outcomes, safety, and indications. [2021]Heart failure (HF) patients are often counseled to limit their physical activity, however, this advice may not be appropriate. Data has accumulated supporting the effectiveness of exercise training to improve fitness levels and symptoms. There are also data suggesting that training may reduce mortality and morbidity in HF patients. Studies have demonstrated that exercise training can be performed safely in appropriately evaluated HF patients. The literature would support the prescribing of exercise training to NYHA II-III HF patients. Consideration could also be given to training stable NYHA IV HF patients who are not symptomatic at rest. This article reviews the effects of exercise training on clinical outcomes and addressing the safety of exercise training and the indications for training in HF patients.
Exercise training in chronic heart failure: mechanisms and therapies. [2022]Decreased exercise capacity negatively affects the individuals' ability to adequately perform activities required for normal daily life and, therefore, the independence and quality of life. Regular exercise training is associated with improved quality of life and survival in healthy individuals and in cardiovascular disease patients. Also in patients with stable heart failure, exercise training can relieve symptoms, improve exercise capacity and reduce disability, hospitalisation and probably mortality. Physical inactivity can thus be considered a major cardiovascular risk factor, and current treatment guidelines recommend exercise training in patients with heart failure in NYHA functional classes II and III. Exercise training is associated with numerous pulmonary, cardiovascular, and skeletal muscle metabolic adaptations that are beneficial to patients with heart failure. This review discusses current knowledge of mechanisms by which exercise training is beneficial in these patients.
Comparison of Supervised Hospital-based versus Educated Home-based Exercise Training in Korean Heart Failure Patients. [2020]Although many clinical trials have shown that exercise training (ET) improves functional capacity and clinical outcomes in heart failure (HF) patients, data comparing supervised hospital-based and educated home-based ET in HF patients is lacking.
How to do: telerehabilitation in heart failure patients. [2019]According to the present guidelines for heart failure patients, regular exercise training has obtained the class of recommendation I, level of evidence A. Despite the benefits of cardiac rehabilitation, many heart failure patients are inactive. Common patient's rejection of existing forms of rehabilitation and limitations resulting from the disease itself hinder the outpatient cardiac rehabilitation. That is why home telerehabilitation seems to be the optimal form of physical activity for heart failure patients.
Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. [2007]Although there are limited clinical data to support the use of exercise training as a means to reduce mortality and morbidity in patients with heart failure, current guidelines state that exercise is beneficial.
Establishing a cardiac training group for patients with heart failure: the "HIP-in-Würzburg" study. [2022]Exercise training in heart failure (HF) is recommended but not routinely offered, because of logistic and safety-related reasons. In 2020, the German Society for Prevention&Rehabilitation and the German Society for Cardiology requested establishing dedicated "HF training groups." Here, we aimed to implement and evaluate the feasibility and safety of one of the first HF training groups in Germany.
Safety and effects of physical training in chronic heart failure. Results of the Chronic Heart Failure and Graded Exercise study (CHANGE) [2007]Physical training is considered to be safe and beneficial as part of the treatment in heart failure patients. Prospective, sufficiently large studies are still needed to confirm this hypothesis.
[Exercise Training and Physical Activity in Patients with Heart Failure]. [2018]Exercise Training and Physical Activity in Patients with Heart Failure Abstract. Heart failure is a clinical syndrome with different etiologies and phenotypes. For all forms, supervised exercise training and individual physical activity are class IA recommendations in current guidelines. Exercise training can start in the hospital, immediately after stabilization of acute heart failure (phase I). After discharge, it can continue in a stationary or ambulatory prevention and rehabilitation program (phase II). Typical components are endurance, resistance and respiratory training. Health insurances cover costs for three to six months. Patients with implantable cardioverter defibrillators or left ventricular assist devices may train in experienced centers. Besides muscular reconditioning, a major goal of phase II is to increase health literacy to improve long-term adherence to physical activity. In phase III, heart groups offer support.
[Physical activity and training in heart failure]. [2019]The main symptoms of chronic heart failure are dyspnea and exercise intolerance. The pathophysiological basis of these symptoms is not simply the dysfunction of the heart, but a complex interaction of the central circulation, the peripheral vessels, the skeletal muscles, the ventilatory, and the endocrine system. In contrast to acute heart failure, where bedrest is known to be beneficial, prolonged limitation of physical activity can be detrimental in the chronic stage of the disease. Therefore, since the 1980s there have been several reports about heart failure patients participating in exercise programs. The results were encouraging: the physiological gains were impressive, and contrary to prior fears, in the great majority of reports no deterioration of the cardiac function could be observed. The net result of training in this condition is an improvement in exercise capacity in the range of the best pharmacological treatment. In detail, blood flow into the working muscle is increased, the ventilation for each given workload is reduced, the skeletal muscle overall function (including biochemical and histological aspects) is improved, the increased neurohormonal activity--especially of the sympathico-adrenergic system--will be normalized, and the patient's quality of life is significantly improved. Whether all of these beneficial aspects will result in improved survival is not yet proven, although one recent study provides some evidence in this direction. But even if today no definite answer to this question from a large, multicenter trial is available, application of exercise training for selected heart failure patients can be recommended, if adequate supervision is provided.
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]The best format of exercise training (ET) in the setting of cardiac rehabilitation in patients with chronic heart failure (CHF) is still to be defined. Current guidelines recommend aerobic exercises, such as running and cycling, including some sessions per week of resistance exercise.
Exercise training in heart failure. [2018]Exercise training (ET) in heart failure (HF) has long been established as an important part of HF care. ET is known to improve quality of life and functional capacity in a number of ways. Despite its proposed benefits, evidence supporting its routine inclusion in standard rehabilitation programme is at times conflicting, partly because of the significant heterogeneity present in available randomised controlled trials. There is lack of evidence with regard to the duration of the overall benefit, the optimal exercise regimen and whether certain types of HF aetiologies benefit more than others. The aim of this review is to provide an update to date literature review of the positive and negative evidence surrounding ET in HF, while proposing an efficient novel in-hospital exercise-based rehabilitation programme for patients with HF in addition to a pre-existing HF clinic.