We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
Trial record 4 of 32 for:    "Myocarditis"

Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03268642
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : September 1, 2017
Information provided by (Responsible Party):
Dao Wen Wang, Tongji Hospital

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.

Condition or disease
Fulminant Myocarditis

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assesment of Clinical Therapeutic Efficacy of "Life-support Based Comprehensive Treatment Regimen" for Adult Fulminant Myocarditis
Study Start Date : February 1, 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
150 hospitalized patients with fulminant myocarditis will be enrolled in this study.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268642

Contact: Yang Sun, MD candidate 86-27-83663280 d201578301@hust.edu.cn

China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Yang Sun, MD candidate    86-27-83663280    d201578301@hust.edu.cn   
Sponsors and Collaborators
Tongji Hospital
Principal Investigator: Dao Wen Wang, Doctor Tongji Hospital

Responsible Party: Dao Wen Wang, Principal Investigator, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03268642     History of Changes
Other Study ID Numbers: TJH-C20160202
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017

Keywords provided by Dao Wen Wang, Tongji Hospital:
Fulminant Myocarditis
Retrospective cohort study

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs