An observational study in Arrhythmia, Cardiomyopathy and Arrhythmia-induced Cardiomyopathy (AiCM), sponsored by Hospital Universitario 12 de Octubre. Recruiting at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Hospital Universitario 12 de Octubre · Observational
The goal of this observational study is to learn about the genetic insights of arrhythmya-induced cardiomyopathy and its clinical prognosis. The main questions it aims to answer are:
I. Does patients with arrhythmia-induced cardiomyopathy have a greater proportion of genetic mutations compared with other types of cardiomyopathy or general population? II. Have the genetics any prognostic impact in patients with arrhythmia-induced cardiomyopathy?
This is a multicentric prospective observational study including patients with suspected arrhythmia-induced cardiomyopathy (AiC) and undergoing rhythm control strategy. AiC suspicion is defined by the presence of left ventricular ejection fraction \<50% with no other more plausible explanation than a new-onset arrhythmia.
Patients who met the inclusion/exclusion criteria will be followed during 1 year after the rhythm control procedure (electric cardioversion or catheter ablation) to asess rhythm control status, imaging remodeling and clinical events. A genetic test will be performed during the study time to asess the existace of genetic variants in cardiomyopathy-related genes. Follow-up visits will be scheduled at 2, 6 and 12 months after inclusion and electrocardiogram and echocardiography will be performed.
AiC will be confirmed in case of left ventricular ejection fraction recovery >10% or absolute value >54% during the follow up imaging evaluations.
Primary analysis will asess the prevalence of pathogenic /likely patogenic variants in patients fullfilling AiC criteria and compared with those who not (without AiC). Secondary analysis will be focused on the incidence of cardiovascular events (heart failure-related and rhythm control-related) during the follow up and its relationship with the genetic background and the AiC status.
Imaging test during follow up will be performed and changes in ventricular and atrial parameters will be used to asess cardiac remodeling.
Further rhythm control asessment will be performed following routinary clinical practice in each participant center.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's planned enrollment of 109 is below the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Hospital Universitario 12 de Octubre is the lead sponsor of 33 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with clinical suspected arrhythmia-induced cardiomyopathy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Presence of known factors causing systolic ventricular dysfunction:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with arrhytmia-induced cardiomyopathy criteria
Patients without arrhytmia-induced cardiomyopathy criteria
Prevalence of pathogenic or likely pathogenic variants in genetic test
Presence of pathogenic/likely pathogenic genetic variant in genetic test
Time frame: Through study completion, an average of 1 year
Heart Failure Admission
Incidence of new hospitalización or urgent visit due to heart failure requiring intravenous diuretics
Time frame: Through study completion, an average of 1 year
Arrhythmia recurrence
Incidence of any atrial tachyarrhytmia (Atrial fibrillation, atrial flutter or atrial tachycardia) conditioning an atrial rate \>150 beats per minute and with a duration of \>5 minutes.
Time frame: Through study completion, an average of 1 year
New unplanned rhythm control procedure
Incidence of unplanned electrical cardioversion or catheter ablation of an atrial tachyarrhythmia (Atrial fibrillation, atrial flutter or atrial tachycardia)
Time frame: Through study completion, an average of 1 year
Atrial reverse remodelling
Incidence of atrial reverse remodelling (ARR). ARR will be considered with a decrease in \>1 degree of atrial dilatation (0=non dilated; 1= mild; 2=moderate; 3=severe) or a decrease \>15% in the left atrial indexed volume
Time frame: Through study completion, an average of 1 year
Cardiovascular Hospitalization
Incidence of unplanned hospital admission due to a cardiovascular aethiology, including acute coronary syndrome, rhythm disorder, heart failure, valvular heart disease, cardiogenic syncope, ischaemic stroke or transient ischaemic attack, acute aortic syndrome, pulmonary or systemic embolism or unexplained sudden cardiac death.
Time frame: Through study completion, an average of 1 year
Mortality
Death of any cause. Cardiovascular death will be also asesed
Time frame: Through study completion, an average of 1 year
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Hospital Universitario 12 de Octubre