Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled crossover feasibility trial (THIAMINE-HF)
Abstract Background Heart failure (HF) is a major cardiovascular disease with increasing prevalence. Thiamine deficiency occurs in 33% of patients with HF. However, the effectiveness of thiamine supplementation in HF is not known. Methods In a placebo-controlled randomized two-period crossover feasi...
Main Authors: | , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2018-09-01
|
Series: | Pilot and Feasibility Studies |
Subjects: | |
Online Access: | http://link.springer.com/article/10.1186/s40814-018-0342-0 |
id |
doaj-562f977ead334118a8355167634095e7 |
---|---|
record_format |
Article |
spelling |
doaj-562f977ead334118a8355167634095e72020-11-25T01:09:32ZengBMCPilot and Feasibility Studies2055-57842018-09-01411710.1186/s40814-018-0342-0Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled crossover feasibility trial (THIAMINE-HF)Eric Kai Chung Wong0Justin Yusen Lee1Darryl P. Leong2Lawrence Mbuagbaw3Haroon Yousuf4Sabina Keen5Sharon E. Straus6Christopher J. Patterson7Catherine Demers8Division of Geriatric Medicine, Faculty of Medicine, University of Toronto, St. Michael’s HospitalDivision of Geriatric Medicine, Department of Medicine, McMaster UniversityDivision of Cardiology, Department of Medicine, McMaster UniversityDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityDivision of General Internal Medicine, Department of Medicine, McMaster UniversityDivision of Geriatric Medicine, Department of Medicine, McMaster UniversityDivision of Geriatric Medicine, Faculty of Medicine, University of TorontoDivision of Geriatric Medicine, Department of Medicine, McMaster UniversityDivision of Cardiology, Department of Medicine, McMaster UniversityAbstract Background Heart failure (HF) is a major cardiovascular disease with increasing prevalence. Thiamine deficiency occurs in 33% of patients with HF. However, the effectiveness of thiamine supplementation in HF is not known. Methods In a placebo-controlled randomized two-period crossover feasibility trial, patients age ≥ 60 years with HF and reduced ejection fraction (HFrEF, EF ≤ 45%) will be randomized to thiamine 500 mg oral capsule once daily or placebo for 3 months, then crossed over to the other intervention after a 6-week washout period. The primary outcome is recruitment rate. Secondary outcomes include feasibility and clinical measures. Feasibility outcomes include refusal rate, retention rate, and compliance rate. Secondary clinical outcomes include left ventricular ejection fraction, peak global longitudinal strain measured by echocardiography, N-terminal prohormone of brain natriuretic peptide (NT-proBNP), New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) quality of life score, and clinical outcomes (all-cause mortality, HF hospitalizations, and HF emergency room visits). Discussion Thiamine is potentially a safe and low-cost treatment for older patients with HFrEF. Results from this study will inform the feasibility of a large clinical trial with clinical endpoints. The findings will be published in a peer review journal and presented at a relevant conference. This study has received full approval from the Hamilton Integrated Research Ethics Board (18-4537) and Health Canada (210603). This trial is funded by the Hamilton Health Sciences New Investigator Grant (15-387) and the McMaster/St. Peter’s Hospital Chair of Aging. Trial registration NCT03228030 (ClinicalTrials.gov), registered July 24, 2017.http://link.springer.com/article/10.1186/s40814-018-0342-0Heart failureThiaminePlaceboCrossoverRandomized controlled trialElderly |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Eric Kai Chung Wong Justin Yusen Lee Darryl P. Leong Lawrence Mbuagbaw Haroon Yousuf Sabina Keen Sharon E. Straus Christopher J. Patterson Catherine Demers |
spellingShingle |
Eric Kai Chung Wong Justin Yusen Lee Darryl P. Leong Lawrence Mbuagbaw Haroon Yousuf Sabina Keen Sharon E. Straus Christopher J. Patterson Catherine Demers Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled crossover feasibility trial (THIAMINE-HF) Pilot and Feasibility Studies Heart failure Thiamine Placebo Crossover Randomized controlled trial Elderly |
author_facet |
Eric Kai Chung Wong Justin Yusen Lee Darryl P. Leong Lawrence Mbuagbaw Haroon Yousuf Sabina Keen Sharon E. Straus Christopher J. Patterson Catherine Demers |
author_sort |
Eric Kai Chung Wong |
title |
Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled crossover feasibility trial (THIAMINE-HF) |
title_short |
Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled crossover feasibility trial (THIAMINE-HF) |
title_full |
Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled crossover feasibility trial (THIAMINE-HF) |
title_fullStr |
Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled crossover feasibility trial (THIAMINE-HF) |
title_full_unstemmed |
Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled crossover feasibility trial (THIAMINE-HF) |
title_sort |
thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled crossover feasibility trial (thiamine-hf) |
publisher |
BMC |
series |
Pilot and Feasibility Studies |
issn |
2055-5784 |
publishDate |
2018-09-01 |
description |
Abstract Background Heart failure (HF) is a major cardiovascular disease with increasing prevalence. Thiamine deficiency occurs in 33% of patients with HF. However, the effectiveness of thiamine supplementation in HF is not known. Methods In a placebo-controlled randomized two-period crossover feasibility trial, patients age ≥ 60 years with HF and reduced ejection fraction (HFrEF, EF ≤ 45%) will be randomized to thiamine 500 mg oral capsule once daily or placebo for 3 months, then crossed over to the other intervention after a 6-week washout period. The primary outcome is recruitment rate. Secondary outcomes include feasibility and clinical measures. Feasibility outcomes include refusal rate, retention rate, and compliance rate. Secondary clinical outcomes include left ventricular ejection fraction, peak global longitudinal strain measured by echocardiography, N-terminal prohormone of brain natriuretic peptide (NT-proBNP), New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) quality of life score, and clinical outcomes (all-cause mortality, HF hospitalizations, and HF emergency room visits). Discussion Thiamine is potentially a safe and low-cost treatment for older patients with HFrEF. Results from this study will inform the feasibility of a large clinical trial with clinical endpoints. The findings will be published in a peer review journal and presented at a relevant conference. This study has received full approval from the Hamilton Integrated Research Ethics Board (18-4537) and Health Canada (210603). This trial is funded by the Hamilton Health Sciences New Investigator Grant (15-387) and the McMaster/St. Peter’s Hospital Chair of Aging. Trial registration NCT03228030 (ClinicalTrials.gov), registered July 24, 2017. |
topic |
Heart failure Thiamine Placebo Crossover Randomized controlled trial Elderly |
url |
http://link.springer.com/article/10.1186/s40814-018-0342-0 |
work_keys_str_mv |
AT erickaichungwong thiamineversusplaceboinolderheartfailurepatientsstudyprotocolforarandomizedcontrolledcrossoverfeasibilitytrialthiaminehf AT justinyusenlee thiamineversusplaceboinolderheartfailurepatientsstudyprotocolforarandomizedcontrolledcrossoverfeasibilitytrialthiaminehf AT darrylpleong thiamineversusplaceboinolderheartfailurepatientsstudyprotocolforarandomizedcontrolledcrossoverfeasibilitytrialthiaminehf AT lawrencembuagbaw thiamineversusplaceboinolderheartfailurepatientsstudyprotocolforarandomizedcontrolledcrossoverfeasibilitytrialthiaminehf AT haroonyousuf thiamineversusplaceboinolderheartfailurepatientsstudyprotocolforarandomizedcontrolledcrossoverfeasibilitytrialthiaminehf AT sabinakeen thiamineversusplaceboinolderheartfailurepatientsstudyprotocolforarandomizedcontrolledcrossoverfeasibilitytrialthiaminehf AT sharonestraus thiamineversusplaceboinolderheartfailurepatientsstudyprotocolforarandomizedcontrolledcrossoverfeasibilitytrialthiaminehf AT christopherjpatterson thiamineversusplaceboinolderheartfailurepatientsstudyprotocolforarandomizedcontrolledcrossoverfeasibilitytrialthiaminehf AT catherinedemers thiamineversusplaceboinolderheartfailurepatientsstudyprotocolforarandomizedcontrolledcrossoverfeasibilitytrialthiaminehf |
_version_ |
1725178222581121024 |