Recruiting
Phase 3

Resveratrol

Sponsor:

St. Boniface Hospital

Code:

NCT01914081

Conditions

Dilated Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Resveratrol

Placebo

Study Details

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.

Conditions

Dilated Cardiomyopathy

Study ID

NCT01914081

Start date

Oct 9, 2018

Status verified date

Nov, 2018

Completion date

Nov, 2020

Anticipated

Primary completion date

Nov, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Resveratrol

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

placebo comparator: Placebo

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

Interventions

Resveratrol

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

Placebo

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

Primary outcome measure

  • Quality of life [ Time Frame: 12 months ]
  • Cardiac Function [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Wendy Janz, RN

204-237-2793wjanz@exchange.mb.ca

Locations

St. Boniface General Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Contacts

Wendy Janz, RN

204-237-2793wjanz@hsc.mb.ca

Principal Investigator:

Shelley Zieroth, MD

More Information

Sponsor

St. Boniface Hospital

Last update posted

Nov 14, 2018

Last verified

Nov, 2018

Keywords

  • dilated cardiomyopathy
  • Resveratrol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Boniface Hospital on 2018-11-14.