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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01914081

Acronym

RES-HF

Enrollment

Registered

2013-08-01

Start date

2018-10-09

Completion date

2020-11-30

Last updated

2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated Cardiomyopathy

Keywords

dilated cardiomyopathy, Resveratrol

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.

Interventions

OTHERResveratrol

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

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Quality of life	12 months	Measured by Minnesota living with heart failure score
Cardiac Function	12 months	Echocardiography

Secondary

Measure	Time frame	Description
Oxidative Stress	12 Months	Measurement of oxidative stress using the Oxiselect TBARS Assay.
Total Antioxidant Status	12 Months	Measurement of total antioxidant status (TAS) level.
Inflammatory Marker Measurements	12 Months	Inflammatory markers will be measured by plasma levels of interleukin 6 (IL6) and tumor necrosis factor (TNF).
Nitric Oxide Determination	12 Months	Total nitric oxide levels will be measured.

Countries

Canada

Contacts

Primary ContactWendy Janz, RN

wjanz@exchange.mb.ca204-237-2793

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026