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

Heart Failure Clinical Trial

— THIAMINE-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228030
• Other study ID #: 15-387
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Beriberi
• Congestive Heart Failure
• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Thiamine Deficiency

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