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| Name | Class |
|---|---|
| McMaster/St. Peter's Hospital Chair of Aging | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thiamine mononitrate 500mg po daily | Experimental | 3 months on thiamine, followed by 6 week washout period, and then 3 months on placebo arm |
|
| Placebo | Placebo Comparator | 3 months on placebo, followed by 6 week washout period, and then 3 months on thiamine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thiamine | Dietary Supplement | Capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Number of participants recruited during the study period. This is a feasibility outcome. | 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Refusal rate | Number of eligible individuals refusing to participate in the research study. This is a feasibility outcome | 11 months |
| Retention rate | Number of participants completing the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric KC Wong, MD FRCPC | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8N3Z5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30258648 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D013832 | Thiamine Deficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
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| ID | Term |
|---|---|
| D013831 | Thiamine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Placebo |
| Dietary Supplement |
Identical capsules |
|
| 11 months |
| Compliance rate | Proportion of participants with >80% adherence to intervention. | 11 months |
| Left ventricular ejection fraction (LVEF) | Echocardiogram measurement of left ventricular ejection fraction. | 3 months |
| Peak global longitudinal strain (%) | Speckle tracking echocardiogram measurement of heart contractility. This is a more sensitive measurement of heart function than LVEF. | 3 months |
| NT-proBNP | Heart failure biomarker | 3 months |
| New York Heart Association (NYHA) class | Heart function symptom grading | 3 months |
| Quality of life | Kansas City Cardiomyopathy Questionnaire | 3 months |
| HF hospitalizations | Number of hospital stays >24h | 7.5 months |
| HF emergency room visits | Number of hospital visits <24h | 7.5 months |
| Death due to cardiovascular causes | As adjudicated by study committee | 7.5 months |
| D003677 |
| Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |