Status:
COMPLETED
Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
McMaster/St. Peter's Hospital Chair of Aging
Conditions:
Heart Failure
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
Heart failure (HF) is a major cardiovascular disease with increasing prevalence. Thiamine deficiency is common in HF patients. Previous small studies have shown that thiamine supplementation can impro...
Eligibility Criteria
Inclusion
- Age ≥60
- NYHA class II-IV symptoms
- Recent HF-related admission in past 12 months OR NT-proBNP \>600ng/L within 60 days of screening
- LVEF ≤45% on 2D/3D echocardiography or radionuclide angiography (RNA) in the past 12 months (on optimal therapy)
- Medically optimized prior to enrolment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker (± neprilysin inhibitor), β-blocker, and/or aldosterone antagonist at target or maximally tolerated doses.
- Patients must be stable on medications without hospitalization in the past month.
Exclusion
- Taking \>2.5mg/d of thiamine supplement. Allows standard multivitamin. B complex vitamin not allowed due to high thiamine content.
- Unable to swallow study medication. A placebo swallowing test will take place at screening.
- Clinical indication for thiamine supplementation including symptomatic thiamine deficiency (Wernicke's encephalopathy, severe malnutrition, refeeding syndrome) and heavy alcohol use, \>15 standard drinks per week in men and \>10 standard drinks per week in women.
- End-stage renal disease on dialysis
- Severe mitral valve disease because this impacts the accuracy of speckle tracking analysis on echocardiography.
- Non-English speaking (unable to complete questionnaires).
- Unable to provide written consent.
- Cognitive impairment without a caregiver administering medications.
- Expected survival \<1 year due to non-cardiac disease.
- Expected heart transplantation in \<6 months (± left ventricular assistive device).
- Allergies to the ingredients of the study medication or placebo
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03228030
Start Date
April 2 2018
End Date
April 30 2021
Last Update
August 31 2021
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada, L8N3Z5