Rajaie Cardiomyopathy and Myocarditis Registry

Recruiting

• Conditions: Natural History; Long-term Outcomes; Clinical Characteristics; Current Therapeutic Approaches

• Registration Number: NCT04304118
• Lead Sponsor: Rajaie Cardiovascular Medical and Research Center

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-11
• Study First Submitted: 2020-01-15
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-07
• Last Update Submitted: 2020-03-07
• Study First Posted: 2020-03-11
• Last Update Posted: 2020-03-11
• Primary Completion: 2020-11-11
• Study Completion: 2025-11-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of sudden death	1 year	unexpected death from a cardiovascular cause in a person with or without preexisting heart disease
Admissions to hospital	1 year	Number of hospitalizations for cardiovascular reasons
Development of chronic heart failure	1 year	significant decrease in left ventricular ejection fraction
Incidence of heart trasplantation	1 year	Cardiac transplantation in patients with end-stage HF who remain symptomatic despite optimal medical therapy
Prevalence of Stroke/Transient ischemic attack	1 year	At least 80% CT/MRI verification of the diagnosis of ischemic stroke/Transient ischemic attack, within the first week of stroke onset

Secondary Outcome Measures

Name	Time	Method
response to current therapeutic approaches	1 year	Implantable cardioverter defibrillator implantation, Cardiac resynchronisation therapy, septal myectomy, ablation, cardiac transplantation and medications

Trial Locations

Locations (1)

Behshid Ghadrdoost; 🇮🇷 Tehran, Iran, Islamic Republic of