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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
McMaster University
Hamilton, Ontario, Canada
Recruitment
Number of participants recruited during the study period. This is a feasibility outcome.
Time frame: 11 months
Refusal rate
Number of eligible individuals refusing to participate in the research study. This is a feasibility outcome
Time frame: 11 months
Retention rate
Number of participants completing the study.
Time frame: 11 months
Compliance rate
Proportion of participants with \>80% adherence to intervention.
Time frame: 11 months
Left ventricular ejection fraction (LVEF)
Echocardiogram measurement of left ventricular ejection fraction.
Time frame: 3 months
Peak global longitudinal strain (%)
Speckle tracking echocardiogram measurement of heart contractility. This is a more sensitive measurement of heart function than LVEF.
Time frame: 3 months
NT-proBNP
Heart failure biomarker
Time frame: 3 months
New York Heart Association (NYHA) class
Heart function symptom grading
Time frame: 3 months
Quality of life
Kansas City Cardiomyopathy Questionnaire
Time frame: 3 months
HF hospitalizations
Number of hospital stays \>24h
Time frame: 7.5 months
HF emergency room visits
Number of hospital visits \<24h
Time frame: 7.5 months
Death due to cardiovascular causes
As adjudicated by study committee
Time frame: 7.5 months
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