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

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

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.

Study Overview

• Status: Unknown
• Conditions: Dilated Cardiomyopathy
• Intervention / Treatment: Other: Resveratrol; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • Recruiting
      • St. Boniface General Hospital
      • Contact: Wendy Janz, RN; Phone Number: 204-237-2793; Email: wjanz@hsc.mb.ca
      • Sub-Investigator: Amrit Malik, MD
      • Principal Investigator: Shelley Zieroth, MD
      • Sub-Investigator: Thomas Netticadan, Ph. D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Boniface Hospital
• Collaborators: Agriculture and Agri-Food Canada; Manitoba Medical Service Foundation; Canadian Centre for Agri-Food Research in Health and Medicine
• Investigators: Principal Investigator: Shelley Zieroth, MD, St. Boniface Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: July 31, 2013
• First Posted (Estimate): August 1, 2013

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: dilated cardiomyopathy; Resveratrol
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: CTA/2012/0002; RRC/2011/1169 (Other Identifier: St. Boniface Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes