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临床试验/NCT00680706
NCT00680706已完成2 期

Targeting Myocardial Energy Metabolism for the Treatment of Acute Heart Failure: The Effect of Thiamine on Biochemical, Electrocardiographic and Respiratory Parameters in Hospitalized Patients.

Baystate Medical Center2 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
131
试验地点
2
主要终点
Effect of Thiamine Supplementation on Dyspnea

研究概览

简要总结

Heart failure remains an increasing cause of morbidity and mortality in the United States even in the face of recent advances in the treatment of cardiovascular disease. There is an urgent need to reevaluate the treatment of heart failure. Shifting substrate utilization used in energy metabolism from fatty acids to glucose is beneficial to the heart presumably by increasing the efficiency of ATP production. Several new drugs for the treatment of cardiac ischemia work by this mechanism. There is increasing evidence that patients with heart failure may also benefit by the same type of intervention. Patients with heart failure are known to have low serum thiamine levels because of poor dietary intake and increased urinary excretion. Inadequate thiamine will deleteriously shift substrate utilization from glucose to fatty acids.

We hypothesize that thiamine supplementation will be beneficial for patients with heart failure by increasing glucose and decreasing fatty acid utilization. This will be initially tested in a pilot double-blinded placebo controlled study of thiamine supplementation in diabetic and non-diabetic patients presenting to the emergency department with acute decompensated heart failure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of heart failure on a loop diuretic.
  • Worsening dyspnea over the past 24 hours.
  • Currently dyspneic sitting or supine, on or off oxygen.
  • Radiographic cephalization of vessels. This criteria is not needed if the patient has no other reason for being dyspneic after being evaluated in the emergency department.
  • Elevated NT pro-BNP (>450).
  • Able to communicate in English or Spanish.
  • Able and willing to provide informed consent.
  • Age > 18 years.
  • A primary admitting diagnosis of acute decompensated heart failure.

排除标准

  • Renal failure on dialysis.
  • Severe valvular disease.
  • EKG criteria for acute myocardial infarction (ST segment elevation > 1mm on two contiguous leads).
  • Initial troponin elevated.
  • Ventricular arrhythmia (ventricular tachycardia or fibrillation).
  • Supraventricular arrhythmia (atrial fibrillation / flutter) with a ventricular rate >120 beats per minute.
  • Taking a daily thiamine supplementation (any multivitamin or specific thiamine supplementation within the past 2 weeks. Fortified foods, such as cereals, are acceptable
  • Taking a daily fatty acid supplement.
  • Pregnancy as determined by standard serum or urine b-HCG assay.

研究组 & 干预措施

Control

Placebo Comparator

干预措施: Placebo (Drug)

Thiamine

Experimental

Receives thiamine

干预措施: Thiamine (Drug)

结局指标

主要结局

Effect of Thiamine Supplementation on Dyspnea

时间窗: 8-Hour

Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Howard Smithline

Chief, Emergency Medicine Research

Baystate Medical Center

研究点 (2)

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