Clinical trial NCT01914081: Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside
Official title: Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside (RES-HF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dilated Cardiomyopathy
Keywords: dilated cardiomyopathy
Resveratrol
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Centre for Agri-Food Research in Health and Medicine
name: Agriculture and Agri-Food Canada
name: Manitoba Medical Service Foundation
First posted: 2013-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life
timeFrame: 12 months
measure: Cardiac Function
timeFrame: 12 months
Secondary outcomes:
measure: Oxidative Stress
timeFrame: 12 Months
measure: Total Antioxidant Status
timeFrame: 12 Months
measure: Inflammatory Marker Measurements
timeFrame: 12 Months
measure: Nitric Oxide Determination
timeFrame: 12 Months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
Study officials:
affiliation: St. Boniface Hospital
name: Shelley Zieroth, MD
role: PRINCIPAL_INVESTIGATOR
References: