Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy
Sweden30 participantsStarted 2017-08-16
Plain-language summary
Hypertrophic cardiomyopathy (HCM) is associated with sudden cardiac death and an increased risk of atrial fibrillation and subsequent embolic event. An insertable cardiac monitor will provide data on cardiac rhythm over a period of 18 months. This will provide an extended monitoring far longer than 24-48 hours of Holter monitoring as is currently usual care. Therefore, detection of arrhythmias could be used in risk stratification and decision-making with regard to offer an implantable defibrillator and anticoagulants.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* hypertrophic cardiomyopathy
Exclusion Criteria:
* aortic stenosis (moderate, severe)
* hypertrophic cardiomyopathy associated with metabolic disease (e.g. Fabry) and syndromes (e.g. Noonan)
* systolic heart failure
* cardiac device (previous pacemaker, implantable defibrillator )
* history of myocardial infarction
* percutaneous coronary intervention and/or coronary artery by-pass grafting
* pulmonary vein isolation, Maze surgery, ventricular tachycardia ablation, ectopic atrial tachycardia ablation
* renal clearance below 40
* malignancy or other comorbidity with less than five years life expectancy
* pregnancy of planned within 18 months
* drug addiction, severe mental disease
* not able to participate in 18 months follow-up
* 5 years risk more than 6% according HCM risk calculator of European Society of Cardiology guidelines.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.