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Completed

NCT Number: NCT03228030

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thiamine

Dietary Supplement

Capsules

Placebo

Dietary Supplement

Identical capsules

Primary outcomes

  1. Recruitment

    Time frame: 11 months

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

Secondary outcomes

  1. Refusal rate

    Time frame: 11 months

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

  2. Retention rate

    Time frame: 11 months

    Number of participants completing the study.

  3. Compliance rate

    Time frame: 11 months

    Proportion of participants with >80% adherence to intervention.

  4. Left ventricular ejection fraction (LVEF)

    Time frame: 3 months

    Echocardiogram measurement of left ventricular ejection fraction.

  5. Peak global longitudinal strain (%)

    Time frame: 3 months

    Speckle tracking echocardiogram measurement of heart contractility. This is a more sensitive measurement of heart function than LVEF.

  6. NT-proBNP

    Time frame: 3 months

    Heart failure biomarker

  7. New York Heart Association (NYHA) class

    Time frame: 3 months

    Heart function symptom grading

  8. Quality of life

    Time frame: 3 months

    Kansas City Cardiomyopathy Questionnaire

  9. HF hospitalizations

    Time frame: 7.5 months

    Number of hospital stays >24h

  10. HF emergency room visits

    Time frame: 7.5 months

    Number of hospital visits <24h

  11. Death due to cardiovascular causes

    Time frame: 7.5 months

    As adjudicated by study committee

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • McMaster/St. Peter's Hospital Chair of Aging

Registry information

Acronym: THIAMINE-HF

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2017
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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