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

NCT04433533 | Unknown Phase 4

• 1 other identifier: 4-2019-1125
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Improvement of diastolic dysfunction

  48 weeks

• Improvement of ventriculoarterial coupling index

  48 weeks

• Improvement of peak VO2

  48 weeks

• Improvement of 6 minute walking test combination therapy and monotherapy

  48 weeks

• Clinical outcomes including death rate

  48 weeks

Study Arms (2)

Rosuvastatin 20mg (Group 1)

ACTIVE COMPARATOR

Drug: Rosuvastatin 20

Rosuvamibe 10/10mg (Group 2)

EXPERIMENTAL

Drug: Rosuvamibe 10/10

Interventions

Rosuvastatin 20 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.

Rosuvastatin 20mg (Group 1)

Rosuvamibe 10/10 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

Rosuvamibe 10/10mg (Group 2)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Hyperlipidemias

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Geu-Ru Hong

CONTACT

82-2-2228-8443; grhong@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: January 6, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)