MEdical Treatment in Idiopathic Ventricular Fibrillation Patients (NCT07405229) | Clinical Trial Compass
RecruitingPhase 4
MEdical Treatment in Idiopathic Ventricular Fibrillation Patients
Denmark218 participantsStarted 2018-05-01
Plain-language summary
A person who has experienced a cardiac arrest with no apparent cause is at risk of having recurrent cardiac arrest. Hence an implantable cardioverter-defibrillator (ICD) is recommended on empirical grounds. Today, there is no uniform way of approaching prevention of recurrence in idiopathic ventricular fibrillation (IVF) patients, beside ICD implantation. Better reatment and risk stratification tools are needed Medical treatment in these patients has never been assessed systematically, but at least some patients with no apparent diagnosis are on betablocker treatment. It is not known if low-doselow dose betablocker treatment is beneficial in these patients.
This study investigates the effect of betablocker treatment to reduce arrhythmic burden in IVF patients.
No predictors for appropriate ICD therapy have been identified in patients with IVF. It is also explored if toxicological and/or genetic profiles, together with in depth machine learning simulation data on repolarization patterns from IVF-ECGs compared to controls, can be used as risk stratification tools.
Lastly, QOL in IVF patients and the impact of beta blocker treatment will be investigated.
Who can participate
Age range
18 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
. Age ≥18 years
. Suspected cardiac cause of cardiac arrest
Exclusion criteria
. With Ischemic heart disease.
. Obvious non-cardiac cause of cardiac arrest
. Congenital heart disease
. Do not speak or understand Danish
. Foreigners -
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.
1This trial is specifically for people with idiopathic ventricular fibrillation — meaning no known underlying heart condition — so how would my doctor confirm that my diagnosis fits that definition before we even consider this study?
2Since the trial is measuring whether patients receive an appropriate shock from their ICD within 3 years, can my doctor explain what 'appropriate therapy' means in practice and what that would feel like or involve for me day-to-day?
3This is a Phase 4 trial, which means the treatments involved have already been approved — so can my doctor walk me through what medical treatments are being tested here and how they compare to what I'd receive outside of a trial?
4Given that I've already survived an out-of-hospital cardiac arrest, how does my doctor weigh the benefits of joining this study against simply continuing with standard ICD management and follow-up care on its own?
5This trial requires up to 3 years of follow-up — what kind of visits, monitoring, or lifestyle commitments would that realistically involve, and is that feasible given my current situation?
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.
What they're measuring
1
First appropriate therapy by ICD or 3 years after discharge