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CompletedNCT03228030THIAMINE-HFUpdated Aug 31, 2021

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Thiamine mononitrate 500mg po daily

    3 months on thiamine, followed by 6 week washout period, and then 3 months on placebo arm

    Dietary Supplement: Thiamine

  • Placebo comparator
    Placebo

    3 months on placebo, followed by 6 week washout period, and then 3 months on thiamine

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementThiamine

    Capsules

  • Dietary supplementPlacebo

    Identical capsules

05

What researchers measure

Primary outcomes

  1. Recruitment

    Number of participants recruited during the study period. This is a feasibility outcome.

    Time frame: 11 months

Secondary outcomes

  1. Refusal rate

    Number of eligible individuals refusing to participate in the research study. This is a feasibility outcome

    Time frame: 11 months

  2. Retention rate

    Number of participants completing the study.

    Time frame: 11 months

  3. Compliance rate

    Proportion of participants with \>80% adherence to intervention.

    Time frame: 11 months

  4. Left ventricular ejection fraction (LVEF)

    Echocardiogram measurement of left ventricular ejection fraction.

    Time frame: 3 months

  5. 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

  6. NT-proBNP

    Heart failure biomarker

    Time frame: 3 months

  7. New York Heart Association (NYHA) class

    Heart function symptom grading

    Time frame: 3 months

  8. Quality of life

    Kansas City Cardiomyopathy Questionnaire

    Time frame: 3 months

  9. HF hospitalizations

    Number of hospital stays \>24h

    Time frame: 7.5 months

  10. HF emergency room visits

    Number of hospital visits \<24h

    Time frame: 7.5 months

  11. Death due to cardiovascular causes

    As adjudicated by study committee

    Time frame: 7.5 months

06

Study locations

1 site
  • McMaster University
    Hamilton, Ontario L8N3Z5, Canada
07

References and documents

Publications

  • 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. PubMed 30258648 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03228030
Lead sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster/St. Peter's Hospital Chair of Aging
Responsible party
Sponsor
First posted
Jul 24, 2017
Start date
Apr 2, 2018
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021
Last update
Aug 31, 2021

Study contacts

Eric KC Wong, MD FRCPC
principal investigator · McMaster University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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