Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial

Phase 1

Completed

• Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Thiamine Deficiency; Congestive Heart Failure
• Interventions: Dietary Supplement: Thiamine; Dietary Supplement: Placebo

• Registration Number: NCT03228030
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-24
• Study Start: 2018-04-02
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Thiamine mononitrate 500mg po daily	Thiamine	3 months on thiamine, followed by 6 week washout period, and then 3 months on placebo arm
Placebo	Placebo	3 months on placebo, followed by 6 week washout period, and then 3 months on thiamine

Primary Outcome Measures

Name	Time	Method
Recruitment	11 months	Number of participants recruited during the study period. This is a feasibility outcome.

Secondary Outcome Measures

Name	Time	Method
Quality of life	3 months	Kansas City Cardiomyopathy Questionnaire
Retention rate	11 months	Number of participants completing the study.
HF hospitalizations	7.5 months	Number of hospital stays \>24h
Death due to cardiovascular causes	7.5 months	As adjudicated by study committee
Compliance rate	11 months	Proportion of participants with \>80% adherence to intervention.
New York Heart Association (NYHA) class	3 months	Heart function symptom grading
Left ventricular ejection fraction (LVEF)	3 months	Echocardiogram measurement of left ventricular ejection fraction.
Refusal rate	11 months	Number of eligible individuals refusing to participate in the research study. This is a feasibility outcome
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
HF emergency room visits	7.5 months	Number of hospital visits \<24h

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada