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| ID | Type | Description | Link |
|---|---|---|---|
| RRC/2011/1169 | Other Identifier | St. Boniface Hospital |
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| Name | Class |
|---|---|
| Canadian Centre for Agri-Food Research in Health and Medicine | OTHER |
| Agriculture and Agri-Food Canada | OTHER_GOV |
| Manitoba Medical Service Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol | Active Comparator | 500 mg (1 capsule BID) of resveratrol for 12 months |
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| Placebo | Placebo Comparator | 500 mg (1 capsule BID) of placebo for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Other | Patients will receive one uncoated immediate-release caplets containing 500 mg resveratrol, twice daily for the 12 month intervention period |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Measured by Minnesota living with heart failure score | 12 months |
| Cardiac Function | Echocardiography | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative Stress | Measurement of oxidative stress using the Oxiselect TBARS Assay. | 12 Months |
| Total Antioxidant Status | Measurement of total antioxidant status (TAS) level. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy Janz, RN | Contact | 204-237-2793 | wjanz@exchange.mb.ca |
| Name | Affiliation | Role |
|---|---|---|
| Shelley Zieroth, MD | St. Boniface Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Boniface General Hospital | Recruiting | Winnipeg | Manitoba | R2H 2A6 | Canada |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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|
| Placebo | Other | Patients will receive one uncoated caplet containing placebo, twice daily for the 12 month intervention period |
|
| 12 Months |
| Inflammatory Marker Measurements | Inflammatory markers will be measured by plasma levels of interleukin 6 (IL6) and tumor necrosis factor (TNF). | 12 Months |
| Nitric Oxide Determination | Total nitric oxide levels will be measured. | 12 Months |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |