Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia
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- STATUS
- Recruiting
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- End date
- Dec 3, 2023
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- participants needed
- 200
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- sponsor
- Yonsei University
Summary
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.
Details
| Condition | Dyslipidemia, Dyslipidemia, Hyperlipidemia, High Cholesterol (Hyperlipidemia), High Cholesterol (Hyperlipidemia), Left Ventricular Diastolic Dysfunction, hyperlipidaemia |
|---|---|
| Treatment | Rosuvastatin 20, Rosuvamibe 10/10 |
| Clinical Study Identifier | NCT04433533 |
| Sponsor | Yonsei University |
| Last Modified on | 3 February 2021 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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