Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis

Fulminant Myocarditis Clinical Trial

Official title:

Assesment of Clinical Therapeutic Efficacy of "Life-support Based Comprehensive Treatment Regimen" for Adult Fulminant Myocarditis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03268642
• Other study ID #: TJH-C20160202
• Status: Recruiting
• Start date: February 1, 2016
• Est. completion date: December 2021

Study information

• Verified date: March 2020
• Source: Tongji Hospital
• Contact: Yang Sun, MD candidate
• Phone: 86-27-83663280
• Email: d201578301[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fulminant Myocarditis
• Myocarditis

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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