Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis

March 10, 2020 updated by: Dao Wen Wang, Tongji Hospital

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through hospital discharge, an average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Principal Investigator: Dao Wen Wang, Doctor, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJH-C20160202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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