Improving exercise tolerance in heart failure patients using antioxidants and exercise training
Overcoming Exercise Intolerance in Veterans With Heart Failure: The Role of NO.
This study is testing if a mix of antioxidants and a specific supplement can help people with heart failure exercise better and feel more energetic.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT03136029 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of oxidative stress and nitric oxide pathways on exercise intolerance in patients with heart failure with reduced ejection fraction (HFrEF). It aims to explore the effects of an oral antioxidant cocktail and tetrahydrobiopterin (BH4) on improving exercise capacity in these patients. The study will include individuals aged 45-75 with stable cardiomyopathy and specific heart failure symptoms, who have been on optimal therapy for at least six weeks. By understanding how these interventions can enhance muscle blood flow and reduce sympathetic nervous system activity, the research seeks to develop new strategies for managing HFrEF.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45-75 with stable HFrEF and NYHA class II or III symptoms.
Not a fit: Patients with atrial fibrillation or those with pacemakers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise tolerance and quality of life for patients suffering from heart failure.
How similar studies have performed: Other studies have shown promise in improving exercise tolerance in heart failure patients through similar interventions, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: General Inclusion/Exclusion Criteria: * The study group will include subjects with a history of stable cardiomyopathy (ischemic and non-ischemic, \>3 months duration, ages 45-75 yrs) despite a minimum of 6 weeks of optimal treatment. * Optimal therapy will be according to American Heart Association (AHA) /American College of Cardiology (ACC) and Heart Failure Society of America (HFSA) HF guidelines, including treatment with angiotensin-converting enzyme (ACE) and -blocker therapy (for at least 6 weeks), or have documented reason for variation, including medication intolerance, contraindication, patient preference, or personal physician's judgment. * Patient enrollment will be limited to those individuals with New York Heart Association (NYHA) class II and III symptoms, left ventricular ejection fraction \<35% (LVEF), with no or minimal smoking history (\<15 pk yrs), and without pacemakers. Exclusion Criteria: * Patients with atrial fibrillation or HF believed to be secondary to atrial fibrillation will be excluded. * Patients with HF secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction) will also be excluded. * Patients will be sedentary, defined here as no regular physical activity for at least the prior 6 months and current activity level will be documented by an activity questionnaire. * Patients must have no orthopedic limitations that would prohibit them from performing knee-extensor exercise. * Due to the typical age of patients with HF, all women will be postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years, and in women without a uterus, follicle stimulating hormone (FSH) \>40 IU/L. * Women currently taking hormone replacement therapy (HRT) will be excluded from the proposed studies due to the direct vascular effects of HRT Comorbidity Exclusion Criteria: Patients with significant non-cardiac comorbidities, which if present could alter the study results, will be excluded. * These include a diagnosis of Dementia * Severe chronic obstructive pulmonary disease (COPD) * Peripheral Vascular Disease * Anemia * Sleep-related Breathing Disorder * Severe Valvular Heart Disease * Diabetes (if on insulin therapy) * or End-stage Malignancy * The investigators will also exclude morbidly obese patients (BMI \>40), patients with uncontrolled Hypertension (\>160/100), Anemia (Hgb\<9) and Severe Renal Insufficiency (individuals with creatinine clearance \<30 by the Cockcroft-Gault formula).
Where this trial is running
Salt Lake City, Utah
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: David W. Wray, PhD — VA Salt Lake City Health Care System, Salt Lake City, UT
- Study coordinator: David W Wray, PhD
- Email: walter.wray@hsc.utah.edu
- Phone: (801) 582-1565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.