Fulminant MyocarditisNCT03268642
Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis
An observational study of Fulminant Myocarditis, run by Tongji Hospital at 1 site in China.
Trial summary
This is a retrospective cohort study to assess the clinical outcome of patients with fulminant myocarditis using "Life-support Based Comprehensive Treatment Regimen" and conventional therapy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Fulminant Myocarditis
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2016to Dec 2021
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 150 hospitalized patients with fulminant myocarditis will be enrolled in this study.
Who may be able to join
- 16 years of age or older;
- Diagnosed as fulminant myocarditis:
- Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (TNI and CK-MB and BNP or NT-pro-BNP);
- Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/or syncope;
- Image for cardiac injury: marked diffused reduction in left ventricle wall movement, with dramatically decreased left ventricle ejection fraction (LVEF) < 45%;
- Cardiogenic shock, e.g., systolic blood pressure ≤90 mmHg or mean arterial pressure < 70mm Hg or a systolic blood pressure decrease > 40 mm Hg, which is associated with the signs of hypofusion: cyanosis, cold extremities, oliguria, and/or changes in mental status.
Who cannot join
- Also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from fulminant myocarditis;
- Myocardial injury caused by sepsis, chemotherapeutical agents, or poisons;
- Unstable hemodynamics or shock caused by hypovolemia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Yang Sun, MD candidate, 86-27-83663280, d201578301@hust.edu.cn
About this study
Official title: Assesment of Clinical Therapeutic Efficacy of "Life-support Based Comprehensive Treatment Regimen" for Adult Fulminant Myocarditis
This is a retrospective cohort study to assess the clinical outcome of patients with fulminant myocarditis using "Life-support Based Comprehensive Treatment Regimen" and conventional therapy. In the present study, participants receive various treatment as part of routine medical care without any assignment of specific interventions to them. The process of treatment during hospitalization were recorded in medical chart and was reviewed by independent research personnel.
- Conditions
- Fulminant Myocarditis
- Keywords
- Fulminant Myocarditis, Retrospective cohort study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Life-support Based Comprehensive Treatment Regimen group | meet all the following conditions: 1. intravenous immune globulin; 2. large dose of glucocorticoids; 3. mechanical ventilation; 4. hemodynamic support: intra-aortic balloon pump (IABP) or/and extracorporeal membrane oxygenation (ECMO); 5. continuous renal replacement therapy. | |
| conventional therapy group | meet one of the following conditions: 1. without/insufficient intravenous immune globulin; 2. without/with various doses of glucocorticoid ; 3. vasoactive drug; 4. without/delayed mechanical ventilation; 5. without/delayed hemodynamic support; 6. without/delayed continuous renal replacement therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
death or cardiac transplantation
The occurrence of death or cardiac transplantation was determined through direct contact with the patient or the family of the patient or review of the patient's medical record.
Measured: through hospital discharge, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Feb 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fulminant MyocarditisStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dao Wen Wang, Tongji Hospital
- Investigators
- Dao Wen Wang, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268642
- Sponsor's protocol ID
- TJH-C20160202
- Status last verified
- Mar 2020
- First submitted
- 17 Aug 2017
- Last updated
- 12 Mar 2020
- Results posted
- No
Publications
Cui G, Nie J, Li H, Wang L, Miao K, Zhao C, Jiang J, Wang DW. The clinicopathologic features of fulminant myocarditis. J Adv Res. 2026 Mar;81:945-953. doi: 10.1016/j.jare.2025.06.040. Epub 2025 Jun 18.
PubMed 40541779He W, Wu J, Wang D, Chen W, Yan Y, He Q, Li C, Yang Q, Huang C, Wen Z, Chen C, He F, Tang L, Wang DW. Plasma proteomics identifies S100A8/A9 as a novel biomarker and therapeutic target for fulminant myocarditis. J Adv Res. 2026 Mar;81:717-730. doi: 10.1016/j.jare.2025.06.005. Epub 2025 Jun 4.
PubMed 40480626Wang J, He M, Li H, Chen Y, Nie X, Cai Y, Xie R, Li L, Chen P, Sun Y, Li C, Yu T, Zuo H, Cui G, Miao K, Zhao C, Jiang J, Heidecker B, Barnett O, Maisel A, Chen C, Wang DW. Soluble ST2 Is a Sensitive and Specific Biomarker for Fulminant Myocarditis. J Am Heart Assoc. 2022 Apr 5;11(7):e024417. doi: 10.1161/JAHA.121.024417. Epub 2022 Apr 4.
PubMed 35377184
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Clinical Therapeutic Efficacy of "Life-support Based Comprehensive Treatment Regimen" for Adult Fulminant Myocarditis
- ClinicalTrials.gov ID
- NCT03268642
- Acronym / sponsor ID
- TJH-C20160202
- Conditions
- Fulminant Myocarditis
- Keywords
- Fulminant Myocarditis, Retrospective cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Feb 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 31 Aug 2017 (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.
This is a retrospective cohort study to assess the clinical outcome of patients with fulminant myocarditis using "Life-support Based Comprehensive Treatment Regimen" and conventional therapy. In the present study, participants receive various treatment as part of routine medical care without any assignment of specific interventions to them. The process of treatment during hospitalization were recorded in medical chart and was reviewed by independent research personnel.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Life-support Based Comprehensive Treatment Regimen group | – | –meet all the following conditions: 1. intravenous immune globulin; 2. large dose of glucocorticoids; 3. mechanical ventilation; 4. hemodynamic support: intra-aortic balloon pump (IABP) or/and extracorporeal membrane oxygenation (ECMO); 5. continuous renal replacement therapy. |
| conventional therapy group | – | –meet one of the following conditions: 1. without/insufficient intravenous immune globulin; 2. without/with various doses of glucocorticoid ; 3. vasoactive drug; 4. without/delayed mechanical ventilation; 5. without/delayed hemodynamic support; 6. without/delayed continuous renal replacement therapy. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 150 hospitalized patients with fulminant myocarditis will be enrolled in this study.
Key inclusion criteria (6 listed)
- 16 years of age or older;
- Diagnosed as fulminant myocarditis:
Key exclusion criteria (3 listed)
- Also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from fulminant myocarditis;
- Myocardial injury caused by sepsis, chemotherapeutical agents, or poisons;
- Unstable hemodynamics or shock caused by hypovolemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
death or cardiac transplantation
Time frame: through hospital discharge, an average of 10 days
The occurrence of death or cardiac transplantation was determined through direct contact with the patient or the family of the patient or review of the patient's medical record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Derived from this study: PubMed 40541779Cui G, Nie J, Li H, Wang L, Miao K, Zhao C, Jiang J, Wang DW. The clinicopathologic features of fulminant myocarditis. J Adv Res. 2026 Mar;81:945-953. doi: 10.1016/j.jare.2025.06.040. Epub 2025 Jun 18.
- Derived from this study: PubMed 40480626He W, Wu J, Wang D, Chen W, Yan Y, He Q, Li C, Yang Q, Huang C, Wen Z, Chen C, He F, Tang L, Wang DW. Plasma proteomics identifies S100A8/A9 as a novel biomarker and therapeutic target for fulminant myocarditis. J Adv Res. 2026 Mar;81:717-730. doi: 10.1016/j.jare.2025.06.005. Epub 2025 Jun 4.
- Derived from this study: PubMed 35377184Wang J, He M, Li H, Chen Y, Nie X, Cai Y, Xie R, Li L, Chen P, Sun Y, Li C, Yu T, Zuo H, Cui G, Miao K, Zhao C, Jiang J, Heidecker B, Barnett O, Maisel A, Chen C, Wang DW. Soluble ST2 Is a Sensitive and Specific Biomarker for Fulminant Myocarditis. J Am Heart Assoc. 2022 Apr 5;11(7):e024417. doi: 10.1161/JAHA.121.024417. Epub 2022 Apr 4.
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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.
Dao Wen Wang, Doctor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fulminant Myocarditis, run by Tongji Hospital at 1 site in China.
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 6 inclusion and 3 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 12 Mar 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 China. 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 Yang Sun, MD candidate (86-27-83663280, d201578301@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death or cardiac transplantation (time frame: through hospital discharge, an average of 10 days). 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 NCT03268642, which also lists 3 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 12 Mar 2020.