Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside

Phase 3

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	500 mg (1 capsule BID) of placebo for 12 months.
Resveratrol	Resveratrol	500 mg (1 capsule BID) of resveratrol for 12 months

Primary Outcome Measures

Name	Time	Method
Cardiac Function	12 months	Echocardiography
Quality of life	12 months	Measured by Minnesota living with heart failure score

Secondary Outcome Measures

Name	Time	Method
Oxidative Stress	12 Months	Measurement of oxidative stress using the Oxiselect TBARS Assay.
Total Antioxidant Status	12 Months	Measurement of total antioxidant status (TAS) level.
Inflammatory Marker Measurements	12 Months	Inflammatory markers will be measured by plasma levels of interleukin 6 (IL6) and tumor necrosis factor (TNF).
Nitric Oxide Determination	12 Months	Total nitric oxide levels will be measured.

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