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

Dilated Cardiomyopathy Clinical Trial

— RES-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01914081
• Other study ID #: CTA/2012/0002
• Secondary ID: RRC/2011/1169
• Status: Recruiting
• Phase: Phase 3
• Start date: October 9, 2018
• Est. completion date: November 2020

Study information

• Verified date: November 2018
• Source: St. Boniface General Hospital Research Centre
• Contact: Wendy Janz, RN
• Phone: 204-237-2793
• Email: wjanz[@]exchange.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Heart Failure

Intervention

Other:
• Resveratrol
Patients will receive one uncoated immediate-release caplets containing 500 mg resveratrol, twice daily for the 12 month intervention period
• Placebo
Patients will receive one uncoated caplet containing placebo, twice daily for the 12 month intervention period

Locations

Country	Name	City	State
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
St. Boniface General Hospital Research Centre	Agriculture and Agri-Food Canada, Canadian Centre for Agri-Food Research in Health and Medicine, Manitoba Medical Service Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Measured by Minnesota living with heart failure score	12 months
Primary	Cardiac Function	Echocardiography	12 months
Secondary	Oxidative Stress	Measurement of oxidative stress using the Oxiselect TBARS Assay.	12 Months
Secondary	Total Antioxidant Status	Measurement of total antioxidant status (TAS) level.	12 Months
Secondary	Inflammatory Marker Measurements	Inflammatory markers will be measured by plasma levels of interleukin 6 (IL6) and tumor necrosis factor (TNF).	12 Months
Secondary	Nitric Oxide Determination	Total nitric oxide levels will be measured.	12 Months