Evaluating the Clinical Efficacy of Resveratrol in Improving Metabolic and Skeletal Muscle Function in Patients With Heart Failure

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a randomized, double-blind, placebo-controlled trial evaluating the effect of resveratrol on metabolic and skeletal muscle function. Patients will be randomized and allocated to either resveratrol or placebo, for 8 weeks with a 2-week run-in period before the intervention period (to ensure they are not on any nutritional supplement that contains resveratrol).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Treatments: Resveratrol

Criteria

Inclusion Criteria:

1. Male: Given the nature of the project and the need to have normative data for variables that may vary by sex, male patients only will be included.

2. Age: Patients should be 50 to 75 years of age. Patients who are younger or older may have variations in skeletal muscle or activity levels that would increase the variation in functional testing.

3. Clinically diagnosed heart failure with reduced ejection fraction (HFrEF; left ventricular ejection fraction <45%) or heart failure with preserved ejection fraction (HFpEF; left ventricular ejection fraction >45%) as defined by the Alberta HEART study.

Exclusion Criteria:

1. Unable to undergo CMR imaging.

2. CMR exclusions: renal failure [a glomerular filtration rate <30 mL/min)], implantable cardiac device (ICD or CRT), uncontrolled atrial fibrillation or recurrent ventricular arrhythmias).

3. General medical conditions: uncontrolled thyroid disorders, hepatic failure, or myocardial revascularization procedures [coronary angioplasty and/or surgical revascularization in the previous 3 months], cancer/malignancy, or with moderate-severe dementia).

4. Patients taking any of the following: oral anticoagulants, insulin, dihydropyridine calcium channel blockers, sildenafil or midazolam.

5. Patients with allergies to the study products.

6. Patients with hormonal disorders.

7. Unwilling to stop regular use of natural health products or dietary supplements containing resveratrol for 14 days prior to study entry and for the duration of the study.