NCT03606824

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

Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in Patients With Atherosclerotic Cardiovascular Diseases (ThyroHeart-Lipid Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Shaochun.Li · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Dyslipidemia
• Subclinical hypothyroïdism
• Statin
• ASCVD

Interventions

Type	Name	Description
DRUG	Pitavastatin and placebo	The initial dosage of pitavastatin is 2mg, and it will be regulated according to the level of LDL-C and the upper limit is 4mg.Since the investigators are blind to the arms,the fake regulation of placebo dosage will be same as the Pitavastatin and levothyroxine group.
DRUG	Pitavastatin and levothyroxine	The initial dosage of pitavastatin is 2mg and the initial dosage of levothyroxine is 12.5ug. The dosage of levothyroxine will be regulated according to thyroid function test every 2-3 weeks. The regulation of pitavastatin dosage is same as the monotherapy group.

Timeline

• Start date: 2019-03-25
• Primary completion: 2020-02-28
• Completion: 2020-05-31
• First posted: 2018-07-31
• Last updated: 2019-03-20

Locations

1 site across 1 country: China