NCT01481402已完成不适用
Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Heart Function, Body Composition and Metabolic Status
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Jens Faber
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- left ventricle ejection fraction
研究概览
简要总结
Purpose: The purpose of the study is to examine if treatment with liothyronine increases left ventricular ejection fraction (LVEF) in patients with stable, chronic heart failure.
详细描述
The patients are examined 3 times. At baseline, after 3 months and after 6 months.After the examination is performed, they begin the study medication while admitted at Dept. of Cardiology, Herlev Hospital, for cardiac monitoring.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable, chronic systolic heart failure
- •T3 ≤1.4 nmol/l in two blood samples, TSH is to be normal
- •LVEF ≤ 45 % on prior echocardiography
排除标准
- •Established thyroid illness
- •Atrial fibrillation/flutter
- •More than 20% ventricular extrasystoles
- •Severe chronic obstructive lung disorder
- •Pregnancy. Pregnancy testing will be done for fertile women
- •Age < 18 years
研究组 & 干预措施
Placebo-liothyronine
Placebo Comparator
3 months of placebo followed by 3 months of Liothyronine treatment.
干预措施: Liothyronine (Drug)
Liothyronine-Placebo
Other
3 months of Liothyronine treatment followed by 3 months of Placebo treatment.
干预措施: Liothyronine (Drug)
结局指标
主要结局
left ventricle ejection fraction
时间窗: 3 months
The effect of liothyronine treatment in low dose in 3 months on LVEF.
次要结局
- GDF 8, SHBG, CK and PINP(3 months)
- Body composition(3 months)
- Quality of Life, questionaire(3 months)
- YKL-40, YNF-alpha, hsCRP and IL-6(3 months)
- RBP 4, HBA1C, adiponectin (high and low weight), glucose and HOMA-1(3 months)
- NT-proBNP, EDV and ESV(3 months)
研究者
研究点 (1)
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