Clinical CharacteristicsNCT04304118
Rajaie Cardiomyopathy and Myocarditis Registry
An observational study of Clinical Characteristics and Natural History, run by Rajaie Cardiovascular Medical and Research Center at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Clinical Characteristics, Natural History, Long-term Outcomes
- How many people
- 6,000 participants
- Where
- 1 siteIran
- Study dates
- 11 Nov 2019to 11 Nov 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria based on the ESC guideline for cardiomyopathy/ myocarditis
Who may be able to join
- 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
Who cannot join
- Patients who have not consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Behshid Ghadrdoost
Tehran
Behshid Ghadrdoost, PhD, +982123923017, behshid.ghadrdoost@yahoo.com
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Admissions to hospital
Number of hospitalizations for cardiovascular reasons
Measured: 1 year
Development of chronic heart failure
significant decrease in left ventricular ejection fraction
Measured: 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
Measured: 1 year
Incidence of sudden death
unexpected death from a cardiovascular cause in a person with or without preexisting heart disease
Measured: 1 year
Incidence of heart trasplantation
Cardiac transplantation in patients with end-stage HF who remain symptomatic despite optimal medical therapy
Measured: 1 year
Secondary outcomes (1)
response to current therapeutic approaches
Implantable cardioverter defibrillator implantation, Cardiac resynchronisation therapy, septal myectomy, ablation, cardiac transplantation and medications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start11 Nov 2019
- Primary completion11 Nov 2020 (estimated)
- Study completion11 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical CharacteristicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Rajaie Cardiovascular Medical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304118
- Sponsor's protocol ID
- registry_98118
- Status last verified
- Mar 2020
- First submitted
- 15 Jan 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rajaie Cardiomyopathy and Myocarditis Registry
- ClinicalTrials.gov ID
- NCT04304118
- Acronym / sponsor ID
- registry_98118
- Conditions
- Clinical Characteristics, Natural History, Long-term Outcomes, Current Therapeutic Approaches
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Rajaie Cardiovascular Medical and Research CenterUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 11 Nov 2020 (estimated)
- Study completion
- 11 Nov 2025 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria based on the ESC guideline for cardiomyopathy/ myocarditis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have not consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Admissions to hospital
Time frame: 1 year
Number of hospitalizations for cardiovascular reasons
Development of chronic heart failure
Time frame: 1 year
significant decrease in left ventricular ejection fraction
Prevalence of Stroke/Transient ischemic attack
Time frame: 1 year
At least 80% CT/MRI verification of the diagnosis of ischemic stroke/Transient ischemic attack, within the first week of stroke onset
Incidence of sudden death
Time frame: 1 year
unexpected death from a cardiovascular cause in a person with or without preexisting heart disease
Incidence of heart trasplantation
Time frame: 1 year
Cardiac transplantation in patients with end-stage HF who remain symptomatic despite optimal medical therapy
1 secondary outcome
response to current therapeutic approaches
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Characteristics and Natural History, run by Rajaie Cardiovascular Medical and Research Center at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Behshid Ghadrdoost, PhD (+982123923017, behshid.ghadrdoost@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admissions to hospital (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.