Evaluating the Clinical Efficacy of Resveratrol in Improving Metabolic and Skeletal Muscle Function in Patients With Heart Failure

NCT03525379 | Completed Phase 2 DMC

• 1 other identifier: REV-HF-2015-1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled trial evaluating the effect of resveratrol on metabolic and skeletal muscle function. Patients will be randomized and allocated to either resveratrol or placebo, for 8 weeks with a 2-week run-in period before the intervention period (to ensure they are not on any nutritional supplement that contains resveratrol).

Conditions

Congestive Heart Failure Chronic

Keywords

Skeletal Muscle Blood Flow; (calf muscle) targeted exercise

Outcome Measures

Primary Outcomes (2)

• Change in Isolated Skeletal Muscle Blood Flow

  In order to evaluate potential changes in skeletal muscle vascular function and oxygen extraction with resveratrol therapy, the investigators will use a lower limb (calf muscle) targeted exercise protocol in conjunction with magnetic resonance imaging (MRI). MRI will be used to measure, simultaneously, the peak rate of blood flow in the calf muscle along with the whole calf muscle extraction of oxygen, which together is used to determine oxygen consumption. This method allows the determinants of oxygen consumption (blood flow and oxygen extraction) to be evaluated, which is necessary to understand the mechanisms of therapy action.

  10 weeks

• Change in Oxygen extraction and consumption

  In order to evaluate potential changes in oxygen extraction with resveratrol therapy, the investigators will use a lower limb (calf muscle) targeted exercise protocol in conjunction with magnetic resonance imaging (MRI). MRI will be used to measure, simultaneously, the peak rate of blood flow in the calf muscle along with the whole calf muscle extraction of oxygen, which together is used to determine oxygen consumption. This method allows the determinants of oxygen consumption (blood flow and oxygen extraction) to be evaluated, which is necessary to understand the mechanisms of therapy action.

  10 weeks

Secondary Outcomes (1)

• Vascular Function by CMR

  10 weeks

Study Arms (2)

Resveratrol

EXPERIMENTAL

1\) Resveratrol- (Transmax) trans- resveratrol (Biotivia Longevity Bioceuticals, LLC, New York, USA) in cellulose capsules. One capsule will be taken orally 2 times per day (BID) for 8 weeks.

Drug: Resveratrol; Drug: Placebo

Placebo

PLACEBO COMPARATOR

2\) Placebo- 500mg (Biotivia Longevity Bioceuticals, LLC, New York, USA) in cellulose capsules. One capsule will be taken orally 2 times per day (BID) for 8 weeks.

Drug: Resveratrol; Drug: Placebo

Interventions

Resveratrol DRUG

Subject participation will be approximately 10 weeks in duration. Participants will be randomized to receive one treatment: either resveratrol for 8 weeks OR placebo for 8 weeks. There will be a 2-week run-in period prior to the treatment period. The schedule for the study is: Week 0 Screening and randomization Weeks 1-2 Run-in; no treatment Weeks 3-10 Treatment Phase (resveratrol or placebo)

Also known as: (Transmax) trans- resveratrol

Placebo; Resveratrol

Placebo DRUG

Participants will be randomized to receive one treatment: either resveratrol for 8 weeks OR placebo for 8 weeks. There will be a 2-week run-in period prior to the treatment period.

Also known as: Subject participation will be approximately 10 weeks in duration. Participants will be randomized to receive one treatment: either resveratrol for 8 weeks OR placebo for 8 weeks

Placebo; Resveratrol

Eligibility Criteria

• Age: 50 Years - 75 Years
• Gender Eligibility Details: Male: Given the nature of the project and the need to have normative data for variables that may vary by sex, male patients only will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male: Given the nature of the project and the need to have normative data for variables that may vary by sex, male patients only will be included.
• Age: Patients should be 50 to 75 years of age. Patients who are younger or older may have variations in skeletal muscle or activity levels that would increase the variation in functional testing.
• Clinically diagnosed heart failure with reduced ejection fraction (HFrEF; left ventricular ejection fraction \<45%) or heart failure with preserved ejection fraction (HFpEF; left ventricular ejection fraction \>45%) as defined by the Alberta HEART study.

You may not qualify if:

• Unable to undergo CMR imaging.
• General medical conditions: uncontrolled thyroid disorders, hepatic failure, or myocardial revascularization procedures \[coronary angioplasty and/or surgical revascularization in the previous 3 months\], cancer/malignancy, or with moderate-severe dementia).
• Patients taking any of the following: oral anticoagulants, insulin, dihydropyridine calcium channel blockers, sildenafil or midazolam.
• Patients with allergies to the study products.
• Patients with hormonal disorders.
• Unwilling to stop regular use of natural health products or dietary supplements containing resveratrol for 14 days prior to study entry and for the duration of the study.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Alberta Cardiovascular and Stroke Research Centre

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The randomization codes will be maintained in REDCap. The principal investigator will have authority to unblind patients if safety concerns arise.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After providing written informed consent, patients who qualify will be randomized via the web-based system coordinated by Research Electronic Data Capture (REDCap) at the University of Alberta. A patient's eligibility will be confirmed and a unique identifier will be assigned. Blinding of the patients and study personnel is preserved by using matching placebo capsules. Clinical outcomes will be adjudicated by a Clinical Events Committee, and core laboratories will assess the CMR measures and biomarkers independently and blinded to treatment assignment.

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: May 15, 2018
• Study Start: October 26, 2017
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: September 19, 2024

Record last verified: 2022-05

Locations

CA (1)