Heart FailurePhase 1THIAMINE-HFNCT03228030
Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial
A Phase 1 study testing Thiamine in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Thiamine Deficiency
- What is being tested?
- Thiamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 2 Apr 2018to 30 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Thiamine, Placebo
- Keywords
- thiamine, heart failure, heart failure with reduced ejection fraction, geriatric, thiamin, vitamin b1, congestive heart failure
- Medical subject headings
- Heart Failure, Thiamine Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiamineDietary supplement
Capsules
PlaceboDietary supplement
Identical capsules
| Study group | Role | What they receive |
|---|---|---|
| Thiamine mononitrate 500mg po daily | Experimental | 3 months on thiamine, followed by 6 week washout period, and then 3 months on placebo arm Receives: Dietary Supplement: Thiamine |
| Placebo | Placebo comparator | 3 months on placebo, followed by 6 week washout period, and then 3 months on thiamine Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of participants recruited during the study period. This is a feasibility outcome.
Measured: 11 months
Secondary outcomes (11)
Refusal rate
Number of eligible individuals refusing to participate in the research study. This is a feasibility outcome
Measured: 11 months
Retention rate
Number of participants completing the study.
Measured: 11 months
Compliance rate
Proportion of participants with >80% adherence to intervention.
Measured: 11 months
Left ventricular ejection fraction (LVEF)
Echocardiogram measurement of left ventricular ejection fraction.
Measured: 3 months
Peak global longitudinal strain (%)
Speckle tracking echocardiogram measurement of heart contractility. This is a more sensitive measurement of heart function than LVEF.
Measured: 3 months
NT-proBNP
Heart failure biomarker
Measured: 3 months
New York Heart Association (NYHA) class
Heart function symptom grading
Measured: 3 months
Quality of life
Kansas City Cardiomyopathy Questionnaire
Measured: 3 months
HF hospitalizations
Number of hospital stays >24h
Measured: 7.5 months
HF emergency room visits
Number of hospital visits <24h
Measured: 7.5 months
Death due to cardiovascular causes
As adjudicated by study committee
Measured: 7.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start2 Apr 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster/St. Peter's Hospital Chair of Aging
- Responsible party
- Sponsor
- Investigators
- Eric KC Wong, MD FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228030
- Sponsor's protocol ID
- 15-387
- Acronym
- THIAMINE-HF
- Status last verified
- Aug 2021
- First submitted
- 20 Jul 2017
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT03228030
- Acronym / sponsor ID
- THIAMINE-HF / 15-387
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster/St. Peter's Hospital Chair of Aging
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thiamine mononitrate 500mg po daily | Experimental | Dietary Supplement: Thiamine3 months on thiamine, followed by 6 week washout period, and then 3 months on placebo arm |
| Placebo | Placebo comparator | Dietary Supplement: Placebo3 months on placebo, followed by 6 week washout period, and then 3 months on thiamine |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThiamineCapsules | Dietary supplement | Thiamine mononitrate 500mg po daily |
| PlaceboIdentical capsules | Dietary supplement | Placebo |
Primary outcome
Recruitment
Time frame: 11 months
Number of participants recruited during the study period. This is a feasibility outcome.
11 secondary outcomes
Refusal rate
Time frame: 11 months
Retention rate
Time frame: 11 months
Compliance rate
Time frame: 11 months
Left ventricular ejection fraction (LVEF)
Time frame: 3 months
Peak global longitudinal strain (%)
Time frame: 3 months
NT-proBNP
Time frame: 3 months
New York Heart Association (NYHA) class
Time frame: 3 months
Quality of life
Time frame: 3 months
HF hospitalizations
Time frame: 7.5 months
HF emergency room visits
Time frame: 7.5 months
Death due to cardiovascular causes
Time frame: 7.5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Derived from this study: PubMed 30258648Wong 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric KC Wong, MD FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thiamine in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03228030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.