Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside (RES-HF)
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- St. Boniface Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Quality of life
Study Overview
Brief Summary
The purpose of this study is to determine if resveratrol can improve heart function and quality of life. Although, population studies have revealed that a mild to moderate intake of red wine reduces cardiovascular disease risk in humans, clinical studies that evaluate the potential heart benefits of resveratrol in patients with non-ischemic cardiomyopathy have not been previously reported. Accordingly, this research is being done because it will fill this deficiency in the information available in the literature and establish the clinical benefits of resveratrol in patients with this type of heart disease.
Detailed Description
The investigators will conduct a randomized double blinded placebo controlled study of 40 adults (≥18 to 90 years old). Twenty (20) subjects will be included in the placebo arm, and 20 in the treatment arm. Patients will be randomly allocated to receive placebo or resveratrol. After randomization, the two groups of subjects will be followed up in exactly the same way, and the only differences between the care they receive will be those intrinsic to the treatment being compared. The randomization will minimize allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects (between 18-90 years of age) with cardiomyopathy, Heart Failure with reduced ejection fraction (HFrEF defined as Left Ventricular Ejection Fraction (LVEF) ≤40%, based on most recent assessment)
- •New York Heart Association (NYHA) Functional class II-III (mild-moderate heart failure symptoms)
- •On optimal medical management for 6 months as per standard care
Exclusion Criteria
- •Severe valvular cardiomyopathy
- •No surgical intervention planned or in past 6 months
- •Subjects on \diltiazem (or any other calcium channel blocker)
- •Patients with a history of serious hypoglycemia requiring hospitalization or hyperglycemic emergencies requiring hospitalization in the past 6 months
- •Subjects on anticoagulants, Coumadin, dabigatran
- •Subjects on HIV protease inhibitor (saquinivir), immunosupressants (cyclosporine, tacrolimus)
- •Subjects on terfenadine, midazolam, and triazolam
- •Subjects on sildenafil or any other drugs used to treat erectile dysfunction
- •• Chronic renal failure (defined as estimated glomerular filtration rate (eGFR) ≤30 mL/min per 1.73m2)
- •Known liver cirrhosis
- •• Other significant comorbidity e.g. cancer affecting ability to complete study
- •Pregnant or lactating women
- •Subjects on hormone replacement therapy
- •Subjects on estrogen containing birth control
Arms & Interventions
Placebo
500 mg (1 capsule BID) of placebo for 12 months.
Intervention: Placebo (Other)
Resveratrol
500 mg (1 capsule BID) of resveratrol for 12 months
Intervention: Resveratrol (Other)
Outcomes
Primary Outcomes
Quality of life
Time Frame: 12 months
Measured by Minnesota living with heart failure score
Cardiac Function
Time Frame: 12 months
Echocardiography
Secondary Outcomes
- Oxidative Stress(12 Months)
- Total Antioxidant Status(12 Months)
- Inflammatory Marker Measurements(12 Months)
- Nitric Oxide Determination(12 Months)
Investigators
Dr. Amrit Malik
Cardiologist
St. Boniface Hospital