Left Ventricular Diastolic DysfunctionPhase 4NCT04433533
Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia
A Phase 4 study testing Rosuvastatin 20 and Rosuvamibe 10/10 in people with Left Ventricular Diastolic Dysfunction and Hyperlipidemias, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Left Ventricular Diastolic Dysfunction, Hyperlipidemias
- What is being tested?
- Rosuvastatin 20 and Rosuvamibe 10/10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jan 2021to Dec 2023
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Severance Hospital
Seoul
Geu-Ru Hong, 82-2-2228-8443, grhong@yuhs.ac
About this study
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
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.
Read more
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.
- Being tested
- Rosuvastatin 20, Rosuvamibe 10/10
- Medical subject headings
- Ventricular Dysfunction, Left, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 20Drug
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 10/10Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 20mg (Group 1) | Active comparator | Not described Receives: Drug: Rosuvastatin 20 |
| Rosuvamibe 10/10mg (Group 2) | Experimental | Not described Receives: Drug: Rosuvamibe 10/10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 48 weeks
Secondary outcomes (6)
Improvement of diastolic dysfunction
Measured: 48 weeks
Improvement of ventriculoarterial coupling index
Measured: 48 weeks
Improvement of peak VO2
Measured: 48 weeks
Improvement of 6 minute walking test combination therapy and monotherapy
Measured: 48 weeks
Clinical outcomes including death rate
Measured: 48 weeks
Clinical outcomes including readmission rate
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start6 Jan 2021
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433533
- Sponsor's protocol ID
- 4-2019-1125
- Status last verified
- Jan 2021
- First submitted
- 12 Jun 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No