Resveratrol: a Potential Anti-remodeling Agent in Heart Failure, From Bench to Bedside
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01914081|
Recruitment Status : Recruiting
First Posted : August 1, 2013
Last Update Posted : April 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-ischemic Cardiomyopathy||Other: Resveratrol Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Resveratrol: a Potential Anti-remodeling Agent in Heart Failure, From Bench to Bedside|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||November 2018|
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.
- Quality of life [ Time Frame: 12 months ]Measured by Minnesota living with heart failure score
- Cardiac Function [ Time Frame: 12 months ]Echocardiography
- Oxidative Stress [ Time Frame: 12 Months ]Measurement of oxidative stress using the Oxiselect TBARS Assay.
- Total Antioxidant Status [ Time Frame: 12 Months ]Measurement of total antioxidant status (TAS) level.
- Inflammatory Marker Measurements [ Time Frame: 12 Months ]Inflammatory markers will be measured by plasma levels of interleukin 6 (IL6) and tumor necrosis factor (TNF).
- Nitric Oxide Determination [ Time Frame: 12 Months ]Total nitric oxide levels will be measured.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914081
|St. Boniface General Hospital||Recruiting|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|Contact: Amrit Malik, MD 204-237-2744 firstname.lastname@example.org|
|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|