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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2021
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Thiamine
Capsules
Placebo
Identical capsules

Locations

Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (2)

Lead Sponsor Collaborator
Hamilton Health Sciences Corporation McMaster/St. Peter's Hospital Chair of Aging

Country where clinical trial is conducted

Canada, 

Outcome

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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