Resveratrol: a Potential Anti-remodeling Agent in Heart Failure, From Bench to Bedside
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Resveratrol: a Potential Anti-remodeling Agent in Heart Failure, From Bench to Bedside|
- Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]Measured by Minnesota living with heart failure score
- Cardiac Function [ Time Frame: 12 months ] [ Designated as safety issue: No ]Echocardiography
- Oxidative Stress [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Measurement of oxidative stress using the Oxiselect TBARS Assay.
- Total Antioxidant Status [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Measurement of total antioxidant status (TAS) level.
- Inflammatory Marker Measurements [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Inflammatory markers will be measured by plasma levels of interleukin 6 (IL6) and tumor necrosis factor (TNF).
- Nitric Oxide Determination [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Total nitric oxide levels will be measured.
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Resveratrol
500 mg (1 capsule BID) of resveratrol for 12 months
Patients will receive one uncoated immediate-release caplets containing 500 mg resveratrol, twice daily for the 12 month intervention period
Other Name: Transmax
Placebo Comparator: Placebo
500 mg (1 capsule BID) of placebo for 12 months.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01914081
|St. Boniface General Hospital||Not yet recruiting|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|Contact: Amrit Malik, MD 204-237-2744 email@example.com|
|Principal Investigator: Amrit Malik, MD|
|Sub-Investigator: Shelley Zieroth, MD|
|Sub-Investigator: Francisco Cordova, MD|
|Sub-Investigator: Thomas Netticadan, Ph. D.|
|Principal Investigator:||Amrit Malik, MD||St. Boniface General Hospital Research Centre|