Clinical trial NCT03228030: Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial
Official title: Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Thiamine Deficiency
Congestive Heart Failure
Keywords: thiamine
heart failure
heart failure with reduced ejection fraction
geriatric
thiamin
vitamin b1
congestive heart failure
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster/St. Peter's Hospital Chair of Aging
First posted: 2017-07-24
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment
timeFrame: 11 months
Secondary outcomes:
measure: Refusal rate
timeFrame: 11 months
measure: Retention rate
timeFrame: 11 months
measure: Compliance rate
timeFrame: 11 months
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 3 months
measure: Peak global longitudinal strain (%)
timeFrame: 3 months
measure: NT-proBNP
timeFrame: 3 months
measure: New York Heart Association (NYHA) class
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: HF hospitalizations
timeFrame: 7.5 months
measure: HF emergency room visits
timeFrame: 7.5 months
measure: Death due to cardiovascular causes
timeFrame: 7.5 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Eric KC Wong, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong EKC, Lee JY, Leong DP, Mbuagbaw L, Yousuf H, Keen S, Straus SE, Patterson CJ, Demers C. Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled crossover feasibility trial (THIAMINE-HF). Pilot Feasibility Stud. 2018 Sep 20;4:149. doi: 10.1186/s40814-018-0342-0. eCollection 2018.