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

Hyperlipidemias Clinical Trial

Official title:

A Randomized, Single-center, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04433533
• Other study ID #: 4-2019-1125
• Status: Recruiting
• Phase: Phase 4
• Start date: January 6, 2021
• Est. completion date: December 2023

Study information

• Verified date: January 2021
• Source: Yonsei University
• Contact: Geu-Ru Hong
• Phone: 82-2-2228-8443
• Email: grhong[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• Left Ventricular Diastolic Dysfunction
• Ventricular Dysfunction, Left

Intervention

Drug:
• 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.
• 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

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum level of low-density lipoprotein cholesterol	Compare the evaluation low-density lipoprotein cholesterol changes in Rosuvastatin/Ezetimibe Combination Therapy versus Rosuvastatin Monotherapy	24 weeks
Primary	Change in serum level of low-density lipoprotein cholesterol	Compare the evaluation low-density lipoprotein cholesterol changes in Rosuvastatin/Ezetimibe Combination Therapy versus Rosuvastatin Monotherapy	48 weeks
Secondary	Improvement of diastolic dysfunction		48 weeks
Secondary	Improvement of ventriculoarterial coupling index		48 weeks
Secondary	Improvement of peak VO2		48 weeks
Secondary	Improvement of 6 minute walking test combination therapy and monotherapy		48 weeks
Secondary	Clinical outcomes including death rate		48 weeks
Secondary	Clinical outcomes including readmission rate		48 weeks