Hyperlipidemias, Left Ventricular Diastolic Dysfunction
Conditions
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 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.
Interventions
DRUGRosuvastatin 20
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 enrolled in a 1: 1 dose of Rosuvastatin 20mg Monotherapy.
DRUGRosuvamibe 10/10
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 enrolled in a 1: 1 dose of rosuvastatin10mg/ezetimibe 10mg combination Therapy
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Participants who have left ventricular diastolic dysfunction (relaxation abnormality, pseudonormalization, restrictive pattern) with preserved left ventricular systolic function (left ventricular ejection fraction ≥ 50%) 2. Adult participants (≥ 20 years old) who have dyslipidemia and need treatment 3. Patients who understand the information about the trial and voluntarily agree to participate in the trial
Exclusion criteria
1. Baseline fasting low-density lipoprotein cholesterol ≤ 70 mg/dL 2. Baseline fasting triglyceride ≥ 400 mg/dL 3. Baseline fasting total cholesterol ≥ 300 mg/dL 4. Participants who have structural heart disease 5. Participants who have prior acute coronary syndrome or cerebrovascular attack within 3 months. 6. Renal dysfunction (estimated glomerular filtration rate \< 30mL/min/1.73m2) 7. Creatinine phosphokinase elevations greater than three times the upper limit of normal 8. Aspartate or alanine aminotransferase elevations greater than three times the upper limit of normal 9. Previous history of rhabdomyolysis 10. Females who are pregnant or breastfeeding or have a plan for pregnancy 11. Life expectancy less than a year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum level of low-density lipoprotein cholesterol | 24 weeks | Compare the evaluation low-density lipoprotein cholesterol changes in Rosuvastatin/Ezetimibe Combination Therapy versus Rosuvastatin Monotherapy |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of ventriculoarterial coupling index | 48 weeks |
| Improvement of peak VO2 | 48 weeks |
| Improvement of diastolic dysfunction | 48 weeks |
| Clinical outcomes including death rate | 48 weeks |
| Clinical outcomes including readmission rate | 48 weeks |
| Improvement of 6 minute walking test combination therapy and monotherapy | 48 weeks |
Countries
South Korea
Contacts
Primary ContactGeu-Ru Hong
Outcome results
None listed