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Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside (RES-HF)

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ClinicalTrials.gov Identifier: NCT01914081
Recruitment Status : Recruiting
First Posted : August 1, 2013
Last Update Posted : November 14, 2018
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

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.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Other: Resveratrol Other: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside (RES-HF)
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
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
Patients will receive one uncoated caplet containing placebo, twice daily for the 12 month intervention period




Primary Outcome Measures :
  1. Quality of life [ Time Frame: 12 months ]
    Measured by Minnesota living with heart failure score

  2. Cardiac Function [ Time Frame: 12 months ]
    Echocardiography


Secondary Outcome Measures :
  1. Oxidative Stress [ Time Frame: 12 Months ]
    Measurement of oxidative stress using the Oxiselect TBARS Assay.

  2. Total Antioxidant Status [ Time Frame: 12 Months ]
    Measurement of total antioxidant status (TAS) level.

  3. Inflammatory Marker Measurements [ Time Frame: 12 Months ]
    Inflammatory markers will be measured by plasma levels of interleukin 6 (IL6) and tumor necrosis factor (TNF).

  4. Nitric Oxide Determination [ Time Frame: 12 Months ]
    Total nitric oxide levels will be measured.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914081


Contacts
Contact: Wendy Janz, RN 204-237-2793 wjanz@exchange.mb.ca

Locations
Canada, Manitoba
St. Boniface General Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Wendy Janz, RN    204-237-2793    wjanz@hsc.mb.ca   
Sub-Investigator: Amrit Malik, MD         
Principal Investigator: Shelley Zieroth, 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: Shelley Zieroth, MD St. Boniface General Hospital Research Centre

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 ( Other Identifier: St. Boniface Hospital )
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Dr. Amrit Malik, St. Boniface General Hospital Research Centre:
dilated cardiomyopathy
Resveratrol

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