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Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial (THIAMINE-HF)

Primary Purpose

Heart Failure, Heart Failure With Reduced Ejection Fraction, Thiamine Deficiency

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Thiamine

Placebo

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring thiamine, heart failure, heart failure with reduced ejection fraction, geriatric, thiamin, vitamin b1, congestive heart failure

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Thiamine mononitrate 500mg po daily

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recruitment

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

Secondary Outcome Measures

Refusal rate

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

Retention rate

Number of participants completing the study.

Compliance rate

Proportion of participants with >80% adherence to intervention.

Left ventricular ejection fraction (LVEF)

Echocardiogram measurement of left ventricular ejection fraction.

Peak global longitudinal strain (%)

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

NT-proBNP

Heart failure biomarker

New York Heart Association (NYHA) class

Heart function symptom grading

Quality of life

Kansas City Cardiomyopathy Questionnaire

HF hospitalizations

Number of hospital stays >24h

HF emergency room visits

Number of hospital visits <24h

Death due to cardiovascular causes

As adjudicated by study committee

Full Information

NCT ID

NCT03228030

First Posted

July 20, 2017

Last Updated

August 30, 2021

Sponsor

Hamilton Health Sciences Corporation

Collaborators

McMaster/St. Peter's Hospital Chair of Aging

1. Study Identification

Unique Protocol Identification Number

NCT03228030

Brief Title

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

Acronym

THIAMINE-HF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

April 2, 2018 (Actual)

Primary Completion Date

April 30, 2021 (Actual)

Study Completion Date

April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hamilton Health Sciences Corporation

Collaborators

McMaster/St. Peter's Hospital Chair of Aging

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thiamine mononitrate 500mg po daily

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Thiamine

Intervention Description

Capsules

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Identical capsules

Primary Outcome Measure Information:

Title

Recruitment

Description

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

Time Frame

11 months

Secondary Outcome Measure Information:

Title

Refusal rate

Description

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

Time Frame

11 months

Title

Retention rate

Description

Number of participants completing the study.

Time Frame

11 months

Title

Compliance rate

Description

Proportion of participants with >80% adherence to intervention.

Time Frame

11 months

Title

Left ventricular ejection fraction (LVEF)

Description

Echocardiogram measurement of left ventricular ejection fraction.

Time Frame

3 months

Title

Peak global longitudinal strain (%)

Description

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

Time Frame

3 months

Title

NT-proBNP

Description

Heart failure biomarker

Time Frame

3 months

Title

New York Heart Association (NYHA) class

Description

Heart function symptom grading

Time Frame

3 months

Title

Quality of life

Description

Kansas City Cardiomyopathy Questionnaire

Time Frame

3 months

Title

HF hospitalizations

Description

Number of hospital stays >24h

Time Frame

7.5 months

Title

HF emergency room visits

Description

Number of hospital visits <24h

Time Frame

7.5 months

Title

Death due to cardiovascular causes

Description

As adjudicated by study committee

Time Frame

7.5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric KC Wong, MD FRCPC

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

McMaster University

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N3Z5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

30258648

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.

Results Reference

derived

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

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