Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT04157205
Eligibility Criteria:
Inclusion criteria
* Does the patient have maximum wall thickness \>13mm by any imaging technique? i) If so, does the patient have a first degree relative (sibling, parent, child) with a formal diagnosis of HCM -AND- ii) Does the patient have any of the following: Does the patient have any of the following: abnormal Doppler myocardial imaging or strain, incomplete systolic anterior motion, elongation of mitral valve leaflets and abnormal papillary muscles, abnormal ECG? -OR-
* Does the patient have maximum wall thickness 15mm or more by any imaging technique?
* Is the patient male or female 18-100years of age?
* High or intermediate risk for sudden cardiac death from HCM based on the ESC risk calculator predicting \>4% risk over 5 years by specialist inherited cardiac disease clinic. This would use the online SCD-risk calculator
Exclusion criteria
* Patients with previous cardiac arrest
* Patients with haemodynamically unstable VT needing medical attention.
* Evidence of one of the following conditions causing secondary hypertrophy:
a. Hypertension \>200/100; Severe aortic stenosis; Anderson-Fabry disease; Myocarditis; Congenital heart disease; TTR-related amyloidosis; Myotonic dystrophy; Mitochondrial disease, Noonan syndrome, LEOPARD syndrome, Costello syndrome, Danon disease, Friedreich's ataxia, Glycogen storage disease, FHLI mutation, PRKAG2 mutations
* Patients with previous appropriate therapy from an ICD.
* Patients under the age of 18 years
* Patients who are not safe to discontinue Beta blockers
* Patients unable to exercise due to musculoskeletal problems
* Patients with skin allergies to ECG gel/electrodes.
* Life expectancy shorter than the duration of the trial.
* Pregnant or planning pregnancy at the time of CT scan.
* Patients unable to consent to the study protocol or provide contact details for follow up.
* Patients currently participating in an interventional medical or device trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04157205
Study Brief:
Protocol Section:
NCT04157205