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

Shaochun.Li

Status: Unknown

Conditions: Statin; Subclinical hypothyroïdism; Dyslipidemia; ASCVD

Treatments: Drug: Pitavastatin and placebo; Drug: Pitavastatin and levothyroxine

Study type: Interventional

Funder types: Other

Identifiers

NCT03606824

2018-zx7

Details and patient eligibility

About

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).

Enrollment: 248 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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248 participants in 2 patient groups, including a placebo group

Pivastatin and placebo

Placebo Comparator group

Description:

After randomization, patients in Pivastatin + placebo group will receive pitavastatin and placebo.

Treatment:

Drug: Pitavastatin and placebo

Pivastatin and LT-4

Experimental group

Description:

After randomization, patients in combination group will receive pitavastatin as the lipid-lowering therapy and take levothyroxine as the thyroid hormone supplement.

Treatment:

Drug: Pitavastatin and levothyroxine