Resveratrol: a Potential Anti-remodeling Agent in Heart Failure, From Bench to Bedside

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by St. Boniface General Hospital Research Centre
Sponsor:
Collaborators:
Canadian Centre for Agri-food Research in Health and Medicine
Agriculture and Agri-Food Canada
Manitoba Medical Service Foundation
Information provided by (Responsible Party):
Dr. Amrit Malik, St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier:
NCT01914081
First received: July 3, 2013
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Non-ischemic Cardiomyopathy
Other: Resveratrol
Other: Placebo
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by St. Boniface General Hospital Research Centre:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: June 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Resveratrol
500 mg (1 capsule BID) of resveratrol for 12 months
Other: Resveratrol
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.
Other: Placebo

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects (between 18-90 years of age) with non-ischemic cardiomyopathy, systolic dysfunction (defined as Left Ventricular Ejection Fraction (LVEF) <40%)
  • 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
  • Normal sinus rhythm

Exclusion Criteria:

  • Ischemic cardiomyopathy
  • Severe valvular cardiomyopathy
  • No surgical intervention planned or in past 6 months
  • Subjects on amiodarone, statins or 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), immunosuppressants (cyclosporine, tacrolimus)
  • Subjects on antihistamine (terfenadine), benzodiazepines (midazolam, triazolam)
  • Subjects on sildenafil or any other drugs used to treat erectile dysfunction
  • Cardiac resynchronization therapy
  • Chronic renal insufficiency
  • Known liver cirrhosis
  • Wide QRS complex width > 120 ms
  • Other significant comorbidity e.g. cancer affecting ability to complete study
  • Pregnant or lactating women
  • Subjects on estrogen containing birth control
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914081

Locations
Canada, Manitoba
St. Boniface General Hospital Not yet recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Amrit Malik, MD    204-237-2744    amalik@sbgh.mb.ca   
Principal Investigator: Amrit Malik, MD         
Sub-Investigator: Shelley Zieroth, MD         
Sub-Investigator: Francisco Cordova, MD         
Sub-Investigator: Thomas Netticadan, Ph. D.         
Sponsors and Collaborators
St. Boniface General Hospital Research Centre
Canadian Centre for Agri-food Research in Health and Medicine
Agriculture and Agri-Food Canada
Manitoba Medical Service Foundation
Investigators
Principal Investigator: Amrit Malik, MD St. Boniface General Hospital Research Centre
  More Information

No publications provided

Responsible Party: Dr. Amrit Malik, Cardiologist, St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier: NCT01914081     History of Changes
Other Study ID Numbers: CTA/2012/0002, RRC/2011/1169
Study First Received: July 3, 2013
Last Updated: April 23, 2014
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by St. Boniface General Hospital Research Centre:
Non-ischemic cardiomyopathy
Resveratrol

Additional relevant MeSH terms:
Resveratrol
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014