Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in ASCVD (ThyroHeart-Lipid Study)

• Status: Unknown status
• Trial end date: 2020-05-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China National Center for Cardiovascular Diseases; Shaochun.Li
• Collaborators: Beijing Chao Yang Hospital; Beijing Friendship Hospital; Chinese Academy of Medical Sciences, Fuwai Hospital; Peking University Third Hospital; Xuanwu Hospital, Beijing
• Treatments: Hormones; Pitavastatin

Criteria

Inclusion Criteria:

1. Male or non-pregnant female;

2. Stable or unstable angina with evidence of myocardial ischemia; coronary angiography reveals stenosis lesions;

3. Subclinical hypothyroidism defined as mild TSH elevation within 5-10mIU/L and normal serum thyroid hormone levels within reference ranges;

4. Level of LDL-C is more than 1.8mmol/L before randomization.

5. Participate in the trial voluntarily and signs the written informed consent form.

Exclusion Criteria:

1. Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit;

2. Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction < 40% (ultrasound or left ventricle ngiography);

3. Pregnant or lactating women;

4. 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.

5. Patients who are unable to withstand lipid-lowering therapy or thyroid hormone replacement due to allergy to statins or levothyroxine;

6. Serum AST/ALT is three times higher than the upper limits of normal.

7. Patient's life expectancy is less than 12 months;

8. Those waiting for heart transplantation;

9. Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.