Congestive Heart Failure, Heart Failure, Heart Failure With Reduced Ejection Fraction, Thiamine Deficiency
Conditions
Keywords
thiamine, heart failure, heart failure with reduced ejection fraction, geriatric, thiamin, vitamin b1, congestive heart failure
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 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.
Interventions
DIETARY_SUPPLEMENTThiamine
Capsules
DIETARY_SUPPLEMENTPlacebo
Identical capsules
Sponsors
McMaster/St. Peter's Hospital Chair of Aging
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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), 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 11 months | Number of participants recruited during the study period. This is a feasibility outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HF emergency room visits | 7.5 months | Number of hospital visits \<24h |
| Death due to cardiovascular causes | 7.5 months | As adjudicated by study committee |
| Refusal rate | 11 months | Number of eligible individuals refusing to participate in the research study. This is a feasibility outcome |
| Retention rate | 11 months | Number of participants completing the study. |
| Compliance rate | 11 months | Proportion of participants with \>80% adherence to intervention. |
| HF hospitalizations | 7.5 months | Number of hospital stays \>24h |
| Peak global longitudinal strain (%) | 3 months | Speckle tracking echocardiogram measurement of heart contractility. This is a more sensitive measurement of heart function than LVEF. |
| NT-proBNP | 3 months | Heart failure biomarker |
| New York Heart Association (NYHA) class | 3 months | Heart function symptom grading |
| Quality of life | 3 months | Kansas City Cardiomyopathy Questionnaire |
| Left ventricular ejection fraction (LVEF) | 3 months | Echocardiogram measurement of left ventricular ejection fraction. |
Countries
Canada
Outcome results
None listed