Heart Failure Clinical Trial
— THIAMINE-HFOfficial title:
Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial
NCT number | NCT03228030 |
Other study ID # | 15-387 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | April 2, 2018 |
Est. completion date | April 30, 2021 |
Verified date | August 2021 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 improve left ventricular systolic function in HF, but larger clinical studies are lacking. Given the ease of supplementation and the potential benefits in HF, we aim to conduct a pilot randomized controlled trial (RCT) using high dose thiamine supplementation in HF patients. The main goal of this pilot study is to determine the feasibility of recruitment for an RCT of thiamine supplementation.
Status | Completed |
Enrollment | 24 |
Est. completion date | April 30, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - 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), ß-blocker, and/or aldosterone antagonist at target or maximally tolerated doses. - Patients must be stable on medications without hospitalization in the past month. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation | McMaster/St. Peter's Hospital Chair of Aging |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment | Number of participants recruited during the study period. This is a feasibility outcome. | 11 months | |
Secondary | Refusal rate | Number of eligible individuals refusing to participate in the research study. This is a feasibility outcome | 11 months | |
Secondary | Retention rate | Number of participants completing the study. | 11 months | |
Secondary | Compliance rate | Proportion of participants with >80% adherence to intervention. | 11 months | |
Secondary | Left ventricular ejection fraction (LVEF) | Echocardiogram measurement of left ventricular ejection fraction. | 3 months | |
Secondary | Peak global longitudinal strain (%) | Speckle tracking echocardiogram measurement of heart contractility. This is a more sensitive measurement of heart function than LVEF. | 3 months | |
Secondary | NT-proBNP | Heart failure biomarker | 3 months | |
Secondary | New York Heart Association (NYHA) class | Heart function symptom grading | 3 months | |
Secondary | Quality of life | Kansas City Cardiomyopathy Questionnaire | 3 months | |
Secondary | HF hospitalizations | Number of hospital stays >24h | 7.5 months | |
Secondary | HF emergency room visits | Number of hospital visits <24h | 7.5 months | |
Secondary | Death due to cardiovascular causes | As adjudicated by study committee | 7.5 months |
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