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

NCT03228030 | Completed Phase 1 DMC

• 1 other identifier: 15-387
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Recruitment

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

  11 months

Secondary Outcomes (11)

• Refusal rate

  11 months

• Retention rate

  11 months

• Compliance rate

  11 months

• Left ventricular ejection fraction (LVEF)

  3 months

• Peak global longitudinal strain (%)

  3 months

Study Arms (2)

Thiamine mononitrate 500mg po daily

EXPERIMENTAL

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

Dietary Supplement: Thiamine

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Thiamine DIETARY_SUPPLEMENT

Capsules

Thiamine mononitrate 500mg po daily

Placebo DIETARY_SUPPLEMENT

Identical capsules

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster/St. Peter's Hospital Chair of Aging: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

Location

Related Publications (1)

• 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.

  PMID: 30258648 DERIVED

MeSH Terms

Conditions

Heart Failure; Thiamine Deficiency

Interventions

Thiamine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Eric KC Wong, MD FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 24, 2017
• Study Start: April 2, 2018
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

CA (1)