A Phase 1 interventional study of Thiamine and Placebo in Heart Failure, Heart Failure With Reduced Ejection Fraction and Thiamine Deficiency, sponsored by Hamilton Health Sciences Corporation. Completed at 1 site in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-08-31.
Sponsored by Hamilton Health Sciences Corporation · Phase 1, Interventional, and Treatment
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 24 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Hamilton Health Sciences Corporation is the lead sponsor of 242 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 months on thiamine, followed by 6 week washout period, and then 3 months on placebo arm
Dietary Supplement: Thiamine
3 months on placebo, followed by 6 week washout period, and then 3 months on thiamine
Dietary Supplement: Placebo
Capsules
Identical capsules
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
Plan to share: Undecided
Ran from Apr 2018 to primary completion in Apr 2021, 36 months.
Of 54 non-industry phase 1 interventional studies under Heart Failure, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 58. This study's 36 months is close to that.
Counting every sponsor, half of 130 studies reached it within 14 months; a quarter within 4 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thiamine
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