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

niversity College Cork0 个研究点目标入组 3,000 人开始时间: 2012年9月12日最近更新: 2017年2月6日

适应症

试验速览

暂无简介。

•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 3000

•Subjects currently on Levothyroxine, antithyroid drugs, 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.
•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 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.

发起方

niversity College Cork