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 Hospital
Collaborators
Canadian Centre for Agri-Food Research in Health and Medicine
Study Sponsor
Shelley Zieroth, MD, Principal Investigator, St. Boniface Hospital
Verification Date
November 2018