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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-09

Study Completion Date

2020-11-30

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.

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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.

Conditions

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Dilated Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Resveratrol

500 mg (1 capsule BID) of resveratrol for 12 months

Group Type ACTIVE_COMPARATOR

Resveratrol

Intervention Type OTHER

Patients will receive one uncoated immediate-release caplets containing 500 mg resveratrol, twice daily for the 12 month intervention period

Placebo

500 mg (1 capsule BID) of placebo for 12 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Patients will receive one uncoated caplet containing placebo, twice daily for the 12 month intervention period

Interventions

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Resveratrol

Patients will receive one uncoated immediate-release caplets containing 500 mg resveratrol, twice daily for the 12 month intervention period

Intervention Type OTHER

Placebo

Patients will receive one uncoated caplet containing placebo, twice daily for the 12 month intervention period

Intervention Type OTHER

Other Intervention Names

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Transmax

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No