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Myocarditis AcuteNCT05933902

Multicenter Retrospective Observational Study of Acute Myocarditis in Korea

An observational study of Myocarditis Acute, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, the investigators analyze the clinical characteristics and prognosis of patients with acute myocarditis in South Korea Read more about this study

Who is it for?
Any age
Conditions the study is for
Myocarditis Acute
How many people
841 participants
Where
1 siteSouth Korea
Study dates
12 Apr 2022to 25 Jan 2023
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients diagnosed with acute myocarditis at 6 domestic hospitals in South Korea from January 2004 to December 2021

Who may be able to join

  • Typical myocarditis symptom and sign, such as fever, chest pain, chest discomfort or shortness of breath, accompanied by elevated myocardial enzymes
  • The above condition is satisfied and additional information is obtained through imaging such as cardiac MRI or cardiac biopsy

Who cannot join

  • ● Coronary artery disease

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official title: Multicenter Retrospective Observational Study to Investigate the Characteristics and Prognosis of Patients With Acute Myocarditis in Korea

In this study, the investigators analyze the clinical characteristics and prognosis of patients with acute myocarditis in South Korea

Read the detailed description

Acute myocarditis refers to a condition in which inflammatory cells infiltrate the heart muscle due to various causes. Until now, there is no clear treatment method for myocarditis itself, and when myocardial function deteriorates or arrhythmia occurs due to myocarditis, it is common to wait for natural recovery while performing general supportive treatment for heart failure.

Through this study, the investigators analyze the factors contributing to the long-term prognosis, myocardial recovery rate, and clinical course of myocarditis. And, the investigators plan to establish an appropriate treatment strategy necessary to increase the survival rate of patients with myocarditis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of In hospital mortality

    In hospital death by any cause

    Measured: through study completion, an average of 1 year

Secondary outcomes (3)

  1. Rate of all-cause mortality

    Death by any cause during follow-up

    Measured: through study completion, an average of 1 year

  2. Requirement of cardiac replacement therapy

    Left ventricular assist device insertion or heart transplantation during follow-up

    Measured: through study completion, an average of 1 year

  3. Rates of Re-hospitalization due to any cause

    Re-hospitalization due to any cause during follow-up

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2023
  2. Study start12 Apr 2022
  3. Primary completion25 Jan 2023
  4. Study completion25 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
841 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05933902
Sponsor's protocol ID
2022-01-003-003
Status last verified
Jul 2023
First submitted
12 May 2023
Last updated
6 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Son J, Kim J, Hong D, Hyun J, Park H, Kim IC, Kim MN, Kim KH, Lee SY, Yang JH. Prognostic value of QRS duration in acute myocarditis: insights from a multicentre cohort study. Eur Heart J Acute Cardiovasc Care. 2026 Aug 29;15(8):608-617. doi: 10.1093/ehjacc/zuag050.

    PubMed 41949022

  • Hong D, Bak M, Park H, Kim HY, Lee S, Kim IC, Hyun J, Kim SR, Kim MN, Kim KH, Yang JH. Association Between Vasoactive Inotropic Score and Clinical Outcomes in Patients With Fulminant Myocarditis. Korean Circ J. 2025 Oct;55(10):938-951. doi: 10.4070/kcj.2024.0445. Epub 2025 May 28.

    PubMed 40628676

  • Hyun J, Pack D, Bak M, Park H, Kim HY, Lee S, Kim IC, Kim SR, Kim MN, Kim KH, Lee SE, Yang JH. Clinical Characteristics and Outcomes of Acute Myocarditis: An Analysis of Korean Multicenter Registry. Korean Circ J. 2025 May;55(5):410-422. doi: 10.4070/kcj.2024.0229. Epub 2024 Dec 10.

    PubMed 39805629

  • Bak M, Hyun J, Park H, Kim HY, Lee S, Kim IC, Kim SR, Kim MN, Kim KH, Yang JH. Early unloading and clinical outcomes in patients with fulminant myocarditis undergoing VA-ECMO: results of a multicenter retrospective study. Rev Esp Cardiol (Engl Ed). 2025 Mar;78(3):176-184. doi: 10.1016/j.rec.2024.06.004. Epub 2024 Jun 25. English, Spanish.

    PubMed 38936469

Questions about this trial

What is this clinical trial studying?

An observational study of Myocarditis Acute, run by Samsung Medical Center 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jul 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of In hospital mortality (time frame: through study completion, an average of 1 year). 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 NCT05933902, which also lists 4 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 6 Jul 2023.

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