Rajaie Cardiomyopathy and Myocarditis Registry

Natural History Clinical Trial

Official title:

Rajaie Cardiomyopathy and Myocarditis Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04304118
• Other study ID #: registry_98118
• Status: Recruiting
• Start date: November 11, 2019
• Est. completion date: November 11, 2025

Study information

• Verified date: March 2020
• Source: Rajaie Cardiovascular Medical and Research Center
• Contact: Behshid Ghadrdoost, PhD
• Phone: +982123923017
• Email: behshid.ghadrdoost[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The prevalence of patients with cardiomyopathies who referred to Rajaei Cardiovascular medical and research center is remarkable, and also the mission of this center is to achieve center of excellence in the field of cardiomyopathy. Rajaie Cardiomyopathy and myocarditis Registry study is an observational registry of consecutive patients with four cardiomyopathy subtypes: hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), and restrictive cardiomyopathy (RCM) as well as myocarditis designed to determine clinical characteristics, natural history, current therapeutic approaches, response to treatment and long-term outcomes of patients with cardiomyopathy and myocarditis and to address limitations in extant evidence to improve prognostication in cardiomyopathies and myocarditis. Prediction of mortality and response to different treatments in these patients using artificial intelligence is another aim of this registry

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: November 11, 2025
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

1. age greater than one year

2. documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria

3. able to give informed consent or in the case of child consent from a parent

Exclusion Criteria:

Patients who have not consent to participate in the study.

Related Conditions & MeSH terms

• Cardiomyopathies
• Clinical Characteristics
• Current Therapeutic Approaches
• Long-term Outcomes
• Myocarditis
• Natural History

Locations

Country	Name	City	State
Iran, Islamic Republic of	Behshid Ghadrdoost	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Rajaie Cardiovascular Medical and Research Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Admissions to hospital	Number of hospitalizations for cardiovascular reasons	1 year
Primary	Development of chronic heart failure	significant decrease in left ventricular ejection fraction	1 year
Primary	Prevalence of Stroke/Transient ischemic attack	At least 80% CT/MRI verification of the diagnosis of ischemic stroke/Transient ischemic attack, within the first week of stroke onset	1 year
Primary	Incidence of sudden death	unexpected death from a cardiovascular cause in a person with or without preexisting heart disease	1 year
Primary	Incidence of heart trasplantation	Cardiac transplantation in patients with end-stage HF who remain symptomatic despite optimal medical therapy	1 year
Secondary	response to current therapeutic approaches	Implantable cardioverter defibrillator implantation, Cardiac resynchronisation therapy, septal myectomy, ablation, cardiac transplantation and medications	1 year