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

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Brief Title

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

Official Title

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

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.
    

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Quality of life

Secondary Outcome

 Oxidative Stress

Condition

Dilated Cardiomyopathy

Intervention

Resveratrol

Study Arms / Comparison Groups

 Resveratrol
Description:  500 mg (1 capsule BID) of resveratrol for 12 months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

40

Start Date

October 9, 2018

Completion Date

November 2020

Primary Completion Date

November 2019

Eligibility 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
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Shelley Zieroth, MD, 204-237-2793, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01914081

Organization ID

CTA/2012/0002

Secondary IDs

RRC/2011/1169

Responsible Party

Principal Investigator

Study Sponsor

St. Boniface General Hospital Research Centre

Collaborators

 Canadian Centre for Agri-Food Research in Health and Medicine

Study Sponsor

Shelley Zieroth, MD, Principal Investigator, St. Boniface General Hospital Research Centre


Verification Date

November 2018