NCT04304118

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2025

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

January 15, 2020

Last Update Submit

March 7, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • Admissions to hospital

    Number of hospitalizations for cardiovascular reasons

    1 year

  • Development of chronic heart failure

    significant decrease in left ventricular ejection fraction

    1 year

  • 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

  • Incidence of sudden death

    unexpected death from a cardiovascular cause in a person with or without preexisting heart disease

    1 year

  • Incidence of heart trasplantation

    Cardiac transplantation in patients with end-stage HF who remain symptomatic despite optimal medical therapy

    1 year

Secondary Outcomes (1)

  • response to current therapeutic approaches

    1 year

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria based on the ESC guideline for cardiomyopathy/ myocarditis

You may qualify if:

  • age greater than one year
  • documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria
  • able to give informed consent or in the case of child consent from a parent

You may not qualify if:

  • Patients who have not consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behshid Ghadrdoost

Tehran, Iran

RECRUITING

Central Study Contacts

Behshid Ghadrdoost, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

March 11, 2020

Study Start

November 11, 2019

Primary Completion

November 11, 2020

Study Completion

November 11, 2025

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations