Dilated CardiomyopathyPhase 3RES-HFNCT01914081
Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside
A Phase 3 study testing Resveratrol in people with Dilated Cardiomyopathy, run by St. Boniface Hospital at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 9 Oct 2018to Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Wendy Janz, RN, 204-237-2793, wjanz@hsc.mb.ca
Amrit Malik, MD
About this study
Official title: Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside (RES-HF)
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.
Read the 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.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- Resveratrol, Placebo
- Keywords
- dilated cardiomyopathy, Resveratrol
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolOther
Also called Transmax
Patients will receive one uncoated immediate-release caplets containing 500 mg resveratrol, twice daily for the 12 month intervention period
PlaceboOther
Patients will receive one uncoated caplet containing placebo, twice daily for the 12 month intervention period
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Active comparator | 500 mg (1 capsule BID) of resveratrol for 12 months Receives: Other: Resveratrol |
| Placebo | Placebo comparator | 500 mg (1 capsule BID) of placebo for 12 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured by Minnesota living with heart failure score
Measured: 12 months
Cardiac Function
Echocardiography
Measured: 12 months
Secondary outcomes (4)
Oxidative Stress
Measurement of oxidative stress using the Oxiselect TBARS Assay.
Measured: 12 Months
Total Antioxidant Status
Measurement of total antioxidant status (TAS) level.
Measured: 12 Months
Inflammatory Marker Measurements
Inflammatory markers will be measured by plasma levels of interleukin 6 (IL6) and tumor necrosis factor (TNF).
Measured: 12 Months
Nitric Oxide Determination
Total nitric oxide levels will be measured.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study start9 Oct 2018
- Primary completionNov 2019 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Centre for Agri-Food Research in Health and Medicine, Agriculture and Agri-Food Canada, Manitoba Medical Service Foundation
- Responsible party
- Principal investigator, Dr. Amrit Malik, St. Boniface Hospital
- Investigators
- Shelley Zieroth, MD, Principal investigator, St. Boniface Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914081
- Sponsor's protocol ID
- CTA/2012/0002
- Other IDs
- RRC/2011/1169
- Acronym
- RES-HF
- Status last verified
- Nov 2018
- First submitted
- 3 Jul 2013
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside (RES-HF)
- ClinicalTrials.gov ID
- NCT01914081
- Acronym / sponsor ID
- RES-HF / CTA/2012/0002
- Conditions
- Dilated Cardiomyopathy
- Keywords
- dilated cardiomyopathy, Resveratrol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- Canadian Centre for Agri-Food Research in Health and Medicine, Agriculture and Agri-Food Canada, Manitoba Medical Service Foundation
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Active comparator | Other: Resveratrol500 mg (1 capsule BID) of resveratrol for 12 months |
| Placebo | Placebo comparator | Other: Placebo500 mg (1 capsule BID) of placebo for 12 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResveratrolAlso: TransmaxPatients will receive one uncoated immediate-release caplets containing 500 mg resveratrol, twice daily for the 12 month intervention period | Other | Resveratrol |
| PlaceboPatients will receive one uncoated caplet containing placebo, twice daily for the 12 month intervention period | Other | Placebo |
Primary outcome
Quality of life
Time frame: 12 months
Measured by Minnesota living with heart failure score
Cardiac Function
Time frame: 12 months
Echocardiography
4 secondary outcomes
Oxidative Stress
Time frame: 12 Months
Total Antioxidant Status
Time frame: 12 Months
Inflammatory Marker Measurements
Time frame: 12 Months
Nitric Oxide Determination
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelley Zieroth, MD principal investigator
St. Boniface Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resveratrol in people with Dilated Cardiomyopathy, run by St. Boniface Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy Janz, RN (204-237-2793, wjanz@exchange.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.