Efficacy and safety of once weekly thyroxine versus daily thyroxine as maintenance therapy of hypothyroidism; a randomized controlled exploratory clinical trial

Dr. D.U.S Bulugahapitiya0 个研究点开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•1. Age >18 years and <70 years
•2. Primary hypothyroidism due to autoimmune hypothyroidism, thyroidectomy or radioiodine treatment
•3. Serum Thyroid-Stimulating Hormone (TSH) and free thyroxine (T4) are within normal range
•4. No change in thyroxine dose in the past 3 months
•5. Baseline blood pressure <140/90 mmHg
•6. Baseline pulse rate <90 bpm
•7. Adequate contraceptive measures for women of childbearing age
•8. Meaningful consent is available

•1. Ischaemic heart disease (previous acute coronary syndrome, stable angina, coronary artery revascularization or evidence of cardiac ischaemia on ECG, exercise ECG or echocardiography)
•2. Pre-existing heart failure or ejection fraction <50% on echocardiography
•3. History of cardiac arrhythmia
•4. Uncontrolled hypertension (BP >140/90 mmHg)
•5. Renal failure with eGFR <45 ml/min/1.73m2
•6. Pre-existing chronic liver disease or liver transaminases >5 times upper limit of normal reference range
•7. Bone fracture in past 3 months
•8. Paget’s disease of bone
•9. Malabsorption
•10. Pregnancy
•11. History of thyroid malignancy
•12. Any terminal disease (eg. advanced heart failure, advanced respiratory disease, malignancy)
•13. Not available for follow-up (e.g. no fixed address, unable to come for regular clinic follow-ups)
•14. Participation in another clinical trial within 3 months

发起方

Dr. D.U.S Bulugahapitiya