Clinical trial NCT04433533: Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Left Ventricular Diastolic Dysfunction
Hyperlipidemias
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in serum level of low-density lipoprotein cholesterol
timeFrame: 24 weeks
measure: Change in serum level of low-density lipoprotein cholesterol
timeFrame: 48 weeks
Secondary outcomes:
measure: Improvement of diastolic dysfunction
timeFrame: 48 weeks
measure: Improvement of ventriculoarterial coupling index
timeFrame: 48 weeks
measure: Improvement of peak VO2
timeFrame: 48 weeks
measure: Improvement of 6 minute walking test combination therapy and monotherapy
timeFrame: 48 weeks
measure: Clinical outcomes including death rate
timeFrame: 48 weeks
measure: Clinical outcomes including readmission rate
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Severance Hospital
Study officials:
References: