A Randomized, Single-center, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in serum level of low-density lipoprotein cholesterol
研究概览
简要总结
preserved left ventricular ejection fraction (LVEF ≥ 50%) and are accompanied by dyslipidemia (LDL ≥ 100 mg / dl) will be enrolled.
Only patients who do not meet the exclusion criteria should be enrolled in the study.
Once the patient is selected, the patient is informed of the study and receives the consent form.
Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly assigned in a 1: 1 dose of rosuvastatin/ezetimibe 10/10mg once daily or rosuvastatin 20 mg once daily. Patients who previously used statins have a wash-out period of 4 weeks or more.
Patients will visit outpatient clinic at 12 weeks and 24 weeks after initiation of treatment. Physical examination, blood test, and 6 minute working test will be performed. For fasting blood tests, patients visit on an empty stomach. Drug adverse events and changes in vital signs or body weight will be checked.
After 48 weeks of treatment, the patients will visit outpatient clinic for efficacy evaluation; physical examination, blood test, transthoracic echocardiography, cardiopulmonary exercise test, central blood pressure, and pulse wave velocity. Drug adverse events and medication compliance will be checked.
The primary endpoint is change of low-density lipoprotein cholesterol and secondary endpoint is improvement of diastolic dysfunction, VAC index, peak VO2, distance of 6 minute working test, and clinical outcomes including death, readmission rate.
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
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have left ventricular diastolic dysfunction (relaxation abnormality, pseudonormalization, restrictive pattern) with preserved left ventricular systolic function (left ventricular ejection fraction ≥ 50%)
- •Adult participants (≥ 20 years old) who have dyslipidemia and need treatment
- •Patients who understand the information about the trial and voluntarily agree to participate in the trial
排除标准
- •Baseline fasting low-density lipoprotein cholesterol ≤ 70 mg/dL
- •Baseline fasting triglyceride ≥ 400 mg/dL
- •Baseline fasting total cholesterol ≥ 300 mg/dL
- •Participants who have structural heart disease
- •Participants who have prior acute coronary syndrome or cerebrovascular attack within 3 months.
- •Renal dysfunction (estimated glomerular filtration rate < 30mL/min/1.73m2)
- •Creatinine phosphokinase elevations greater than three times the upper limit of normal
- •Aspartate or alanine aminotransferase elevations greater than three times the upper limit of normal
- •Previous history of rhabdomyolysis
- •Females who are pregnant or breastfeeding or have a plan for pregnancy
- •Life expectancy less than a year.
研究组 & 干预措施
Rosuvastatin 20mg (Group 1)
干预措施: Rosuvastatin 20 (Drug)
Rosuvamibe 10/10mg (Group 2)
干预措施: Rosuvamibe 10/10 (Drug)
结局指标
主要结局
Change in serum level of low-density lipoprotein cholesterol
时间窗: 48 weeks
Compare the evaluation low-density lipoprotein cholesterol changes in Rosuvastatin/Ezetimibe Combination Therapy versus Rosuvastatin Monotherapy
次要结局
- Improvement of peak VO2(48 weeks)
- Improvement of ventriculoarterial coupling index(48 weeks)
- Clinical outcomes including death rate(48 weeks)
- Improvement of 6 minute walking test combination therapy and monotherapy(48 weeks)
- Improvement of diastolic dysfunction(48 weeks)
- Clinical outcomes including readmission rate(48 weeks)