Hypertrophic Cardiomyopathy Clinical Trial
Official title:
Efficacy of Risk Assessment for Sudden Cardiac Death in Patients With Hypertrophic Cardiomyopathy
NCT number | NCT04402268 |
Other study ID # | PoznanUMP |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2014 |
Est. completion date | February 28, 2019 |
Verified date | May 2020 |
Source | Poznan University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left ventricular myocardium and is most often caused by mutations in sarcomere genes. The structural and functional abnormalities cannot be explained by flow-limiting coronary artery disease or loading conditions. The disease affects at least 0,2% of the population worldwide and is the most common cause of sudden cardiac death (SCD) in young people and competitive athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign course. Therefore, it is of utmost importance to properly evaluate patients and identify those who would benefit from a cardioverter-defibrillator (ICD) implantation.
Status | Completed |
Enrollment | 252 |
Est. completion date | February 28, 2019 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Hypertrophic cardiomyopathy, 2. Minimum 18 years, 3. Questionnaire, 4. Assessment of HCM SCD-Risk Calculator at the beginning of the observation, 5. Regular visits in Cardiology Outpatient Clinic, 6. Agreement to participate in the study Exclusion Criteria: 1. Poorly controlled hypertension (systolic pressure on the next two visits in the Cardiology Outpatient Clinic >180 mmHg), 2. Haemodynamically significant valvular heart disease or valve replacement condition, 3. Past myocardial infarction (haemodynamically significant changes found in coronarography), 4. Heart transplant, 5. Insufficient amount of data from the subject and additional tests allowing for further analysis, 6. Lack of consent to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Poland | Poznan Univeristy of Medical Sciences | Poznan | Wielkopolska |
Lead Sponsor | Collaborator |
---|---|
Poznan University of Medical Sciences |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sudden cardiac death (SCD) in risk groups | Number of SCD cases in each of risk groups according to HCM Risk-SCD Calculator | 2005-2018 | |
Secondary | New risk factors of sudden cardiac death (SCD) | New echocardiographic features, such as glibal longitudinal strain, average strain, left atrial volume index, which allow to better estimate the risk of SCD | 2005-2018 |
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