EUCTR2011-004554-26-NL进行中（未招募）1 期
Multimodal effects of Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism; a randomised placebo controlled Trial (TRUST) - Thyroid hormone replacement for subclinical hypothyroidism
eiden University Medical Center, division 30 个研究点目标入组 750 人开始时间: 2012年10月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Community-dwelling patients aged >=65 years with SCH.
- •SCH is defined as persistently elevated TSH levels (>=4.6 and =19.9 mU/L) and free thyroxine (fT4) in reference range measured on a minimum of two occasions at least 3 months apart.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 750
排除标准
- •Subjects currently on Levothyroxine, antithyroid drugs , amiodarone or lithium.
- •Recent thyroid surgery or radio-iodine therapy (within 12 months).
- •Grade IV NYHA heart failure.
- •Prior clinical diagnosis of dementia.
- •Recent hospitalisation for major illness or elective surgery (within 4 weeks).
- •Recent acute coronary syndrome, including myocardial infarction or unstable angina (within 4 weeks).
- •Acute myocarditis or acute pancarditis
- •Untreated adrenal insufficiency
- •Terminal illness.
- •Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •Subjects who are participating in ongoing RCTs of therapeutic interventions (including clinical trials of investigational medicinal products [CTIMPs])
- •Plan to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period).
- •Atrial fibrillation (sustained or paroxysmal) will not be an exclusion, as in itself this cardiac arrhythmia is not a contra-indication to Levothyroxine treatment. In addition, AF is a common finding in the studied age groups and exclusion of subjects with it would potentially compromise the generalisability of our results.
- •Adherence to treatment allocation: drop-ins (where subjects allocated to placebo are prescribed Levothyroxine) and drop outs (where subjects allocated to Levothyroxine stop this treatment) are each estimated at less than 5% at 1 year and less than 10% at the end of the study (mean 3 years follow-up).
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