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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside (RES-HF)

Conditions
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Dilated Cardiomyopathy

Intervention / Treatment
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* Other: Resveratrol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resveratrol<br>500 mg (1 capsule BID) of resveratrol for 12 months | Other: Resveratrol<br>* Patients will receive one uncoated immediate-release caplets containing 500 mg resveratrol, twice daily for the 12 month intervention period<br>* Other names: Transmax;|
| Placebo Comparator: Placebo<br>500 mg (1 capsule BID) of placebo for 12 months. | Other: Placebo<br>* Patients will receive one uncoated caplet containing placebo, twice daily for the 12 month intervention period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Measured by Minnesota living with heart failure score | 12 months | 
| Cardiac Function | Echocardiography | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dilated cardiomyopathy, Resveratrol