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

  • STATUS
    Recruiting
  • End date
    Dec 3, 2023
  • participants needed
    200
  • sponsor
    Yonsei University
Updated on 3 February 2021

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.

Details
Condition Dyslipidemia, Dyslipidemia, Hyperlipidemia, High Cholesterol (Hyperlipidemia), High Cholesterol (Hyperlipidemia), Left Ventricular Diastolic Dysfunction, hyperlipidaemia
Treatment Rosuvastatin 20, Rosuvamibe 10/10
Clinical Study IdentifierNCT04433533
SponsorYonsei University
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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