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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04433533
- Acronym / sponsor ID
- 4-2019-1125
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 20mg (Group 1) | Active comparator | Drug: Rosuvastatin 20 |
| Rosuvamibe 10/10mg (Group 2) | Experimental | Drug: Rosuvamibe 10/10 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin 20Patients 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. | Drug | Rosuvastatin 20mg (Group 1) |
| Rosuvamibe 10/10Patients 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 | Drug | Rosuvamibe 10/10mg (Group 2) |
Primary outcome
Change in serum level of low-density lipoprotein cholesterol
Time frame: 24 weeks
Compare the evaluation low-density lipoprotein cholesterol changes in Rosuvastatin/Ezetimibe Combination Therapy versus Rosuvastatin Monotherapy
Change in serum level of low-density lipoprotein cholesterol
Time frame: 48 weeks
Compare the evaluation low-density lipoprotein cholesterol changes in Rosuvastatin/Ezetimibe Combination Therapy versus Rosuvastatin Monotherapy
6 secondary outcomes
Improvement of diastolic dysfunction
Time frame: 48 weeks
Improvement of ventriculoarterial coupling index
Time frame: 48 weeks
Improvement of peak VO2
Time frame: 48 weeks
Improvement of 6 minute walking test combination therapy and monotherapy
Time frame: 48 weeks
Clinical outcomes including death rate
Time frame: 48 weeks
Clinical outcomes including readmission rate
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geu-Ru Hong (82-2-2228-8443, grhong@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum level of low-density lipoprotein cholesterol (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.