NCT01914081

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
5.2 years until next milestone

Study Start

First participant enrolled

October 9, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

1.1 years

First QC Date

July 3, 2013

Last Update Submit

November 9, 2018

Conditions

Dilated Cardiomyopathy

Keywords

dilated cardiomyopathyResveratrol

Outcome Measures

Primary Outcomes (2)

  • Quality of life

    Measured by Minnesota living with heart failure score

    12 months

  • Cardiac Function

    Echocardiography

    12 months

Secondary Outcomes (4)

  • Oxidative Stress

    12 Months

  • Total Antioxidant Status

    12 Months

  • Inflammatory Marker Measurements

    12 Months

  • Nitric Oxide Determination

    12 Months

Study Arms (2)

Resveratrol

ACTIVE COMPARATOR

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

Other: Resveratrol

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

ResveratrolOTHER

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

Also known as: Transmax
Resveratrol
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Shelley Zieroth, MD

    St. Boniface Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Janz, RN

CONTACT

204-237-2793wjanz@exchange.mb.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

July 3, 2013

First Posted

August 1, 2013

Study Start

October 9, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2020

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)