Status:
UNKNOWN
Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside
Lead Sponsor:
St. Boniface Hospital
Collaborating Sponsors:
Canadian Centre for Agri-Food Research in Health and Medicine
Agriculture and Agri-Food Canada
Conditions:
Dilated Cardiomyopathy
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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 c...
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01914081
Start Date
October 9 2018
End Date
November 1 2020
Last Update
November 14 2018
Active Locations (1)
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1
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6