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

Primary Purpose

Dilated Cardiomyopathy

Status

Unknown status

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Resveratrol

Placebo

About this trial

This is an interventional treatment trial for Dilated Cardiomyopathy focused on measuring dilated cardiomyopathy, Resveratrol

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Boniface General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Resveratrol

Placebo

Arm Description

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

500 mg (1 capsule BID) of placebo for 12 months.

Outcomes

Primary Outcome Measures

Quality of life

Measured by Minnesota living with heart failure score

Cardiac Function

Echocardiography

Secondary Outcome Measures

Oxidative Stress

Measurement of oxidative stress using the Oxiselect TBARS Assay.

Total Antioxidant Status

Measurement of total antioxidant status (TAS) level.

Inflammatory Marker Measurements

Inflammatory markers will be measured by plasma levels of interleukin 6 (IL6) and tumor necrosis factor (TNF).

Nitric Oxide Determination

Total nitric oxide levels will be measured.

Full Information

NCT ID

NCT01914081

First Posted

July 3, 2013

Last Updated

November 9, 2018

Sponsor

St. Boniface Hospital

Collaborators

Canadian Centre for Agri-Food Research in Health and Medicine, Agriculture and Agri-Food Canada, Manitoba Medical Service Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01914081

Brief Title

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

Acronym

RES-HF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 9, 2018 (Actual)

Primary Completion Date

November 2019 (Anticipated)

Study Completion Date

November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. Boniface Hospital

Collaborators

Canadian Centre for Agri-Food Research in Health and Medicine, Agriculture and Agri-Food Canada, Manitoba Medical Service Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dilated Cardiomyopathy

Keywords

dilated cardiomyopathy, Resveratrol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Resveratrol

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

500 mg (1 capsule BID) of placebo for 12 months.

Intervention Type

Other

Intervention Name(s)

Resveratrol

Other Intervention Name(s)

Transmax

Intervention Description

Patients will receive one uncoated immediate-release caplets containing 500 mg resveratrol, twice daily for the 12 month intervention period

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Quality of life

Description

Measured by Minnesota living with heart failure score

Time Frame

12 months

Title

Cardiac Function

Description

Echocardiography

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Oxidative Stress

Description

Measurement of oxidative stress using the Oxiselect TBARS Assay.

Time Frame

12 Months

Title

Total Antioxidant Status

Description

Measurement of total antioxidant status (TAS) level.

Time Frame

12 Months

Title

Inflammatory Marker Measurements

Description

Inflammatory markers will be measured by plasma levels of interleukin 6 (IL6) and tumor necrosis factor (TNF).

Time Frame

12 Months

Title

Nitric Oxide Determination

Description

Total nitric oxide levels will be measured.

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wendy Janz, RN

Phone

204-237-2793

wjanz@exchange.mb.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shelley Zieroth, MD

Organizational Affiliation

St. Boniface Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Boniface General Hospital

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2H 2A6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wendy Janz, RN

Phone

204-237-2793

wjanz@hsc.mb.ca

First Name & Middle Initial & Last Name & Degree

Amrit Malik, MD

First Name & Middle Initial & Last Name & Degree

Shelley Zieroth, MD

First Name & Middle Initial & Last Name & Degree

Thomas Netticadan, Ph. D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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