Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT04433533
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT04433533
Study Brief:
Protocol Section:
NCT04433533