PMID- 30258648
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220321
IS  - 2055-5784 (Print)
IS  - 2055-5784 (Electronic)
IS  - 2055-5784 (Linking)
VI  - 4
DP  - 2018
TI  - Thiamine versus placebo in older heart failure patients: study protocol for a 
      randomized controlled crossover feasibility trial (THIAMINE-HF).
PG  - 149
LID - 10.1186/s40814-018-0342-0 [doi]
LID - 149
AB  - 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.
FAU - Wong, Eric Kai Chung
AU  - Wong EKC
AUID- ORCID: 0000-0003-1759-8603
AD  - 1Division of Geriatric Medicine, Faculty of Medicine, University of Toronto, St. 
      Michael's Hospital, 30 Bond Street, Toronto, Ontario M5B 1W8 Canada. ISNI: 0000 
      0001 2157 2938. GRID: grid.17063.33
AD  - 2GERAS Centre, Hamilton Health Sciences, McMaster University, 88 Maplewood Ave, 
      Hamilton, Ontario L8M 1W9 Canada. ISNI: 0000 0004 1936 8227. GRID: grid.25073.33
FAU - Lee, Justin Yusen
AU  - Lee JY
AD  - 3Division of Geriatric Medicine, Department of Medicine, McMaster University, 88 
      Maplewood Ave, Hamilton, Ontario L8M 1W9 Canada. ISNI: 0000 0004 1936 8227. GRID: 
      grid.25073.33
FAU - Leong, Darryl P
AU  - Leong DP
AD  - 4Division of Cardiology, Department of Medicine, McMaster University, 237 Barton 
      Street E, Hamilton, Ontario L8L 2X2 Canada. ISNI: 0000 0004 1936 8227. GRID: 
      grid.25073.33
FAU - Mbuagbaw, Lawrence
AU  - Mbuagbaw L
AD  - 5Department of Health Research Methods, Evidence, and Impact, McMaster 
      University, 50 Charlton Ave. E, Hamilton, Ontario L8N 4A6 Canada. ISNI: 0000 0004 
      1936 8227. GRID: grid.25073.33
FAU - Yousuf, Haroon
AU  - Yousuf H
AD  - 6Division of General Internal Medicine, Department of Medicine, McMaster 
      University, 50 Charlton Ave. E, Hamilton, Ontario L8N 4A6 Canada. ISNI: 0000 0004 
      1936 8227. GRID: grid.25073.33
FAU - Keen, Sabina
AU  - Keen S
AD  - 7Division of Geriatric Medicine, Department of Medicine, McMaster University, 
      2757 King St. E, Hamilton, Ontario L8G 5E4 Canada. ISNI: 0000 0004 1936 8227. 
      GRID: grid.25073.33
FAU - Straus, Sharon E
AU  - Straus SE
AD  - 8Division of Geriatric Medicine, Faculty of Medicine, University of Toronto, St. 
      Michael's Hospital, 30 Bond Street, Toronto, Ontario M5B 1W8 Canada. ISNI: 0000 
      0001 2157 2938. GRID: grid.17063.33
FAU - Patterson, Christopher J
AU  - Patterson CJ
AD  - 3Division of Geriatric Medicine, Department of Medicine, McMaster University, 88 
      Maplewood Ave, Hamilton, Ontario L8M 1W9 Canada. ISNI: 0000 0004 1936 8227. GRID: 
      grid.25073.33
FAU - Demers, Catherine
AU  - Demers C
AD  - 4Division of Cardiology, Department of Medicine, McMaster University, 237 Barton 
      Street E, Hamilton, Ontario L8L 2X2 Canada. ISNI: 0000 0004 1936 8227. GRID: 
      grid.25073.33
LA  - eng
SI  - ClinicalTrials.gov/NCT03228030
PT  - Journal Article
DEP - 20180920
PL  - England
TA  - Pilot Feasibility Stud
JT  - Pilot and feasibility studies
JID - 101676536
PMC - PMC6149004
OTO - NOTNLM
OT  - Crossover
OT  - Elderly
OT  - Heart failure
OT  - Placebo
OT  - Randomized controlled trial
OT  - Thiamine
COIS- The authors declare that they have no competing interests.Springer Nature remains 
      neutral with regard to jurisdictional claims in published maps and institutional 
      affiliations.
EDAT- 2018/09/28 06:00
MHDA- 2018/09/28 06:01
PMCR- 2018/09/20
CRDT- 2018/09/28 06:00
PHST- 2018/05/22 00:00 [received]
PHST- 2018/09/12 00:00 [accepted]
PHST- 2018/09/28 06:00 [entrez]
PHST- 2018/09/28 06:00 [pubmed]
PHST- 2018/09/28 06:01 [medline]
PHST- 2018/09/20 00:00 [pmc-release]
AID - 342 [pii]
AID - 10.1186/s40814-018-0342-0 [doi]
PST - epublish
SO  - Pilot Feasibility Stud. 2018 Sep 20;4:149. doi: 10.1186/s40814-018-0342-0. 
      eCollection 2018.