Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in ASCVD (ThyroHeart-… (NCT03606824) | Clinical Trial Compass
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Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in ASCVD (ThyroHeart-Lipid Study)
China248 participantsStarted 2019-03-25
Plain-language summary
In ASCVD patients complicated with subclinical hypothyroidism, the percentage of those who did not reach the target of lipid-lowering therapy (LDL-C\>1.8mmol/L) is usually higher than that in population with normal thyroid function. The present study aims to randomly compare two lipid-lowering therapeutic strategies (statins only vs. statins combined with thyroid hormone supplement).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or non-pregnant female;
✓. Stable or unstable angina with evidence of myocardial ischemia; coronary angiography reveals stenosis lesions;
✓. Subclinical hypothyroidism defined as mild TSH elevation within 5-10mIU/L and normal serum thyroid hormone levels within reference ranges;
✓. Level of LDL-C is more than 1.8mmol/L before randomization.
✓. Participate in the trial voluntarily and signs the written informed consent form.
Exclusion criteria
✕. Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit;
✕. Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction \< 40% (ultrasound or left ventricle ngiography);
✕. Pregnant or lactating women;
✕. Complicated with severe organ dysfunction: large number of pericardial effusion; acute myocardial infarction; acute myocarditis; acute left heart failure; cardiogenic shock; severe arrhythmia, such as ventricular tachycardia, ventricular fibrillation, frequent atrial / ventricular premature beat, poor control of fast ventricular fibrillation, and bradycardia requiring pacemaker therapy, etc.
✕. Patients who are unable to withstand lipid-lowering therapy or thyroid hormone replacement due to allergy to statins or levothyroxine;