Dilated CardiomyopathyNCT04174456
Combination of Olmesartan Effect on Myocardial Viability of Patients With Dilated Cardiomyopathy
A study testing FDG PET in people with Dilated Cardiomyopathy, run by Dong-A University at 1 site in South Korea.
Trial summary
The study proceeds with prospective, randomized, open and controlled clinical trials. The subject of the investigator's study was the first patient diagnosed with dilated cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- FDG PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2019to 31 Dec 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dilated cardiomyopathy
Who cannot join
- contraindication to angiotensin receptor blocker
- cardiogenic shock
- sensitive to rosuvastatin
- liver cirrhosis more than Child class B
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Internal Medicine,Dong-A University College of Medicine
Busan
Kyungil Park, MD, 82-51-240-2733, sotier@dau.ac.kr
Sua Jo, MD, 82-10-3900-9713, flysofina@gmail.com
About this study
Official title: Olmesartan Effect on Myocardial Viability of Patients With Dilated Cardiomyopathy
The study proceeds with prospective, randomized, open and controlled clinical trials. The subject of the investigator's study was the first patient diagnosed with dilated cardiomyopathy. Subjects who agreed to participate in the study and were determined to meet the selection / exclusion criteria were randomly assigned to each group, and the experimental group was treated with 20 mg of olmesartan and 5 mg of rosuvastatin for 6 months, and the control group is treated with 40 mg of valsartan and 5 mg of rosuvastatin.
Read the detailed description
Myocardial viability plays an important role in improving the function of the heart. To date, the most reproducible and objective method has been established as a method or tool for assessing myocardial viability.
Olmesartan is known to have the strongest inhibitory ability of angiotensin receptors compared with other angiotensin receptor binding inhibitors. Research has been reported that statin drugs may help improve vascular endothelial function, and several researchers have suggested that these mechanisms may affect the improvement of myocardial survival. In addition, studies have shown that angiotensin receptor binding inhibitors and statins may improve left ventricular function in patients with left ventricular function. However, since the studies did not assess myocardial survival, the mechanisms could not be clearly identified.
The purpose of this study is to investigate the effect of olmesartan on myocardial survival in patients with dilated cardiomyopathy who have left ventricular dysfunction.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- FDG PET
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PETDiagnostic test
baseline and 6-month follow-up FDG PET
| Study group | Role | What they receive |
|---|---|---|
| Olmesartan group | Experimental | olmesartan 20mg once daily with rosuvastatin 5mg once a day for 6-month Receives: Diagnostic Test: FDG PET |
| Valsartan group | Active comparator | valsartan 40mg twice daily with rosuvastatin 5mg once a day for 6-month Receives: Diagnostic Test: FDG PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of glucose metabolism
data from fludeoxyglucose positron emission tomography
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Dec 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyungil Park, Dong-A University
- Investigators
- Kyungil PARK, Study director, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174456
- Sponsor's protocol ID
- 18-215
- Status last verified
- Aug 2020
- First submitted
- 18 Nov 2019
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't have any plan to make individual participant data (IPD) available to other researchers
Publications
Jo S, Park K, Choi JH, Sohn CB, Kim J, Kwon YS, Kim SH, Park TH. A Comparison Study of Olmesartan and Valsartan Effects on Myocardial Metabolism in Patients With Dilated Cardiomyopathy: the OVOID Trial. J Am Heart Assoc. 2025 Jul;14(13):e041406. doi: 10.1161/JAHA.125.041406. Epub 2025 Jun 27.
PubMed 40576039Jo S, Moon H, Park K, Sohn CB, Kim J, Kwon YS, Kim SH. Design and rationale for a comparison study of Olmesartan and Valsartan On myocardial metabolism In patients with Dilated cardiomyopathy (OVOID) trial: study protocol for a randomized controlled trial. Trials. 2022 Jan 15;23(1):36. doi: 10.1186/s13063-021-05970-7.
PubMed 35033178
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olmesartan Effect on Myocardial Viability of Patients With Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04174456
- Acronym / sponsor ID
- 18-215
- Conditions
- Dilated Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Nov 2019 (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.
The study proceeds with prospective, randomized, open and controlled clinical trials. The subject of the investigator's study was the first patient diagnosed with dilated cardiomyopathy. Subjects who agreed to participate in the study and were determined to meet the selection / exclusion criteria were randomly assigned to each group, and the experimental group was treated with 20 mg of olmesartan and 5 mg of rosuvastatin for 6 months, and the control group is treated with 40 mg of valsartan and 5 mg of rosuvastatin.
Detailed description
Myocardial viability plays an important role in improving the function of the heart. To date, the most reproducible and objective method has been established as a method or tool for assessing myocardial viability.
Olmesartan is known to have the strongest inhibitory ability of angiotensin receptors compared with other angiotensin receptor binding inhibitors. Research has been reported that statin drugs may help improve vascular endothelial function, and several researchers have suggested that these mechanisms may affect the improvement of myocardial survival. In addition, studies have shown that angiotensin receptor binding inhibitors and statins may improve left ventricular function in patients with left ventricular function. However, since the studies did not assess myocardial survival, the mechanisms could not be clearly identified.
The purpose of this study is to investigate the effect of olmesartan on myocardial survival in patients with dilated cardiomyopathy who have left ventricular dysfunction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olmesartan group | Experimental | Diagnostic Test: FDG PETolmesartan 20mg once daily with rosuvastatin 5mg once a day for 6-month |
| Valsartan group | Active comparator | Diagnostic Test: FDG PETvalsartan 40mg twice daily with rosuvastatin 5mg once a day for 6-month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- dilated cardiomyopathy
Key exclusion criteria (4 listed)
- contraindication to angiotensin receptor blocker
- cardiogenic shock
- sensitive to rosuvastatin
- liver cirrhosis more than Child class B
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 |
|---|---|---|
| FDG PETbaseline and 6-month follow-up FDG PET | Diagnostic test | Olmesartan group, Valsartan group |
Primary outcome
Rate of glucose metabolism
Time frame: 6 month
data from fludeoxyglucose positron emission tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Derived from this study: PubMed 40576039Jo S, Park K, Choi JH, Sohn CB, Kim J, Kwon YS, Kim SH, Park TH. A Comparison Study of Olmesartan and Valsartan Effects on Myocardial Metabolism in Patients With Dilated Cardiomyopathy: the OVOID Trial. J Am Heart Assoc. 2025 Jul;14(13):e041406. doi: 10.1161/JAHA.125.041406. Epub 2025 Jun 27.
- Derived from this study: PubMed 35033178Jo S, Moon H, Park K, Sohn CB, Kim J, Kwon YS, Kim SH. Design and rationale for a comparison study of Olmesartan and Valsartan On myocardial metabolism In patients with Dilated cardiomyopathy (OVOID) trial: study protocol for a randomized controlled trial. Trials. 2022 Jan 15;23(1):36. doi: 10.1186/s13063-021-05970-7.
- Individual participant dataSharing planned: No. We don't have any plan to make individual participant data (IPD) available to other researchers
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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.
Kyungil PARK study director
Dong-A University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG PET in people with Dilated Cardiomyopathy, run by Dong-A 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 1 inclusion and 4 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 26 Aug 2020. 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.
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 Kyung-Mi Ko (82-51-240-5740, kkmcrc@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of glucose metabolism (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04174456, which also lists 2 linked publications.
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 26 Aug 2020.