Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia

NCT ID: NCT04433533

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-06
• Study Completion Date: 2023-12-31

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.

Conditions

Left Ventricular Diastolic Dysfunction; Hyperlipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rosuvastatin 20mg (Group 1)

Group Type: ACTIVE_COMPARATOR

Rosuvastatin 20

Intervention Type: DRUG

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.

Rosuvamibe 10/10mg (Group 2)

Group Type: EXPERIMENTAL

Rosuvamibe 10/10

Intervention Type: DRUG

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

Interventions

Rosuvastatin 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.

Intervention Type: DRUG

Rosuvamibe 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Geu-Ru Hong

Role: CONTACT

grhong@yuhs.ac

82-2-2228-8443

Facility Contacts

Geu-Ru Hong

Role: primary

grhong@yuhs.ac

82-2-2228-8443

Other Identifiers

4-2019-1125

Identifier Type: -

Identifier Source: org_study_id