Multi-modal effects of Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism; a randomised placebo-controlled Trial (TRUST) - Thyroid hormone replacement for subclinical hypothyroidism

HS Greater Glasgow and Clyde0 个研究点目标入组 737 人开始时间: 2012年9月7日最近更新: 2019年4月30日

适应症

试验速览

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•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: 0
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3000

•Subjects currently on Levothyroxine, antithyroid medication (eg. Carbimazole, methimazole, propylthiouracil, potassium percholate), amiodarone or lithium. • Recent thyroid surgery or radio-iodine (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). • Terminal illness. • Subjects who are participating in ongoing RCTs of therapeutic interventions (including 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 thyroxine treatment. In addition atrial fibrillation is a common finding in the studied age groups and exclusion of subjects with it would potentially compromise the generalisability of our results.

发起方

HS Greater Glasgow and Clyde