Status:
UNKNOWN
Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia
Lead Sponsor:
Yonsei University
Conditions:
Left Ventricular Diastolic Dysfunction
Hyperlipidemias
Eligibility:
All Genders
20-85 years
Phase:
PHASE4
Brief 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 enro...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04433533
Start Date
January 6 2021
End Date
December 1 2023
Last Update
January 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yonsei Severance Hospital
Seoul, South Korea