Status:
COMPLETED
A Trial of Thiamin Supplementation in Patients With Heart Failure
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Heart and Stroke Foundation of Ontario
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Background: Patients with heart failure (HF) are at increased risk of developing thiamin deficiency (TD). Thiamin (vitamin B1) is required for the production of energy and therefore TD may contribute ...
Detailed Description
Background: There is now accumulating evidence that patients with heart failure (HF) have a high prevalence of thiamin deficiency (TD). Since thiamin is a key cofactor in the enzyme systems that produ...
Eligibility Criteria
Inclusion
- primary diagnosis of ischemic, dilated, idiopathic or valvular heart failure characterized by an ejection fraction of \< 45% (echocardiography or radionuclide scan)
- have an optimized medication regimen (ACE inhibitor or angiotensin receptor blocker, and beta blocker at target doses, or up-titrated to the maximum doses as tolerated)
- been stable (on current medication regimen with no hospitalizations for acute decompensated heart failure \> 2 months) prior to entry into the study
Exclusion
- Participants will be excluded if they are:
- unable or unwilling to provide informed consent
- have any concurrent condition which would result in thiamin deficiency, namely gastrointestinal disorders, magnesium deficiency, liver disease, thyrotoxicosis, B12 deficiency, folate deficiency, prolonged diarrhoeal disease, dialysis, prolonged fever or infection, recent myocardial infarction, coronary revascularization (percutaneous coronary intervention or coronary artery bypass surgery within 3 months), or renal failure
- are rapidly deteriorating, who are not on a stable medication regimen (2 months or more) or who have been hospitalized for acute decompensated heart failure in the last 2 months
- are on experimental medications
- are taking vitamin supplements containing thiamin \>10mg/day
- consume excessive alcohol (\> 3 drinks per day), have a documented history of alcoholism or have documented alcoholic cardiomyopathy
- have permanent atrial fibrillation
- are pregnant or would like to become pregnant
- have a right-to-left, bidirectional, or transient right to left cardiac shunts
- have clinically suspected wet Beri Beri in the opinion of the treating physician
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00959075
Start Date
September 1 2009
End Date
November 1 2015
Last Update
February 27 2018
Active Locations (1)
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1
Niagara North Family Health Team
St. Catharines, Ontario, Canada, L2R 1R5