Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Placebo
3 months on placebo, followed by 6 week washout period, and then 3 months on thiamine
干预措施: Placebo (Dietary Supplement)
Thiamine mononitrate 500mg po daily
3 months on thiamine, followed by 6 week washout period, and then 3 months on placebo arm
干预措施: Thiamine (Dietary Supplement)
结局指标
主要结局
Recruitment
时间窗: 11 months
Number of participants recruited during the study period. This is a feasibility outcome.
次要结局
- NT-proBNP(3 months)
- Quality of life(3 months)
- Retention rate(11 months)
- HF hospitalizations(7.5 months)
- Compliance rate(11 months)
- New York Heart Association (NYHA) class(3 months)
- Left ventricular ejection fraction (LVEF)(3 months)
- Death due to cardiovascular causes(7.5 months)
- Refusal rate(11 months)
- Peak global longitudinal strain (%)(3 months)
- HF emergency room visits(7.5 months)