NCT03268642

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

4.8 years

First QC Date

August 17, 2017

Last Update Submit

March 10, 2020

Conditions

Fulminant Myocarditis

Keywords

Fulminant MyocarditisRetrospective cohort study

Outcome Measures

Primary Outcomes (1)

  • 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.

    through hospital discharge, an average of 10 days

Study Arms (2)

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.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

150 hospitalized patients with fulminant myocarditis will be enrolled in this study.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (3)

  • 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. 2025 Jun 18:S2090-1232(25)00449-7. doi: 10.1016/j.jare.2025.06.040. Online ahead of print.

    PMID: 40541779DERIVED

  • He 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. 2025 Jun 4:S2090-1232(25)00391-1. doi: 10.1016/j.jare.2025.06.005. Online ahead of print.

    PMID: 40480626DERIVED

  • Wang 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.

    PMID: 35377184DERIVED

Study Officials

  • Dao Wen Wang, Doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Sun, MD candidate

CONTACT

86-27-83663280d201578301@hust.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 31, 2017

Study Start

February 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

CN(1)