NCT03606824Unknown不适用
Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in Patients With Atherosclerotic Cardiovascular Diseases (ThyroHeart-Lipid Study)
Shaochun.Li1 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2019年3月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Change of LDL-C levels
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Serum AST/ALT is three times higher than the upper limits of normal.
- •Patient's life expectancy is less than 12 months;
- •Those waiting for heart transplantation;
- •Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.
研究组 & 干预措施
Pivastatin and placebo
Placebo Comparator
After randomization, patients in Pivastatin + placebo group will receive pitavastatin and placebo.
干预措施: Pitavastatin and placebo (Drug)
Pivastatin and LT-4
Experimental
After randomization, patients in combination group will receive pitavastatin as the lipid-lowering therapy and take levothyroxine as the thyroid hormone supplement.
干预措施: Pitavastatin and levothyroxine (Drug)
结局指标
主要结局
Change of LDL-C levels
时间窗: Baseline and 6-month.
Absolute change value of serum LDL-C levels between the baseline and 6-month assessment.
次要结局
- Dosage of treatment drugs (pitavastatin and levothyroxine)(At 6-month assessment.)
- Levels of thyroid hormones at 6-month assessment(At 6-month assessment.)
- Rates of major adverse cardiac and cerebrovascular events at 6-month assessment(During 6-month follow-up.)
- Levels of glutamic-pyruvic transaminase (ALT) at 1-, 2-, 3- and 6-month assessment(Baseline and 1-, 2-, 3- and 6-month assessment.)
- Changes of non-LDL lipid levels (TC, TG, HDL-C, non-HDL-C)(Baseline and 6-month)
- LDL-C control rate(Baseline and 1-, 2-, 3- and 6-month assessment.)
- Levels of glutamic-oxaloacetic transaminase (AST) at 1-, 2-, 3- and 6-month assessment(Baseline and 1-, 2-, 3- and 6-month assessment.)
- Levels of serum creatine kinase (CK) at 1-, 2-, 3- and 6-month assessment(Baseline and 1-, 2-, 3- and 6-month assessment.)
研究者
Shaochun.Li
Consultant physician
China National Center for Cardiovascular Diseases
研究点 (1)
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