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

Phase 3UnknownNCT01914081

St. Boniface Hospital40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dilated Cardiomyopathy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Quality of life

Measured by Minnesota living with heart failure score

Time frame: 12 months

Cardiac Function

Echocardiography

Time frame: 12 months

Secondary Outcomes

Oxidative Stress

Measurement of oxidative stress using the Oxiselect TBARS Assay.

Time frame: 12 Months

Total Antioxidant Status

Measurement of total antioxidant status (TAS) level.

Time frame: 12 Months

Inflammatory Marker Measurements

Inflammatory markers will be measured by plasma levels of interleukin 6 (IL6) and tumor necrosis factor (TNF).

Time frame: 12 Months

Nitric Oxide Determination

Total nitric oxide levels will be measured.

Time frame: 12 Months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts