Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitario 12 de Octubre
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presence of atrial fibrillation or atrial flutter not self-limited.
Performance of a cardiac imaging test with systolic function analysis (echocardiogram, magnetic resonance, CT scan) during the clinical course of the arrhythmia, exhibiting a left ventricular ejection fraction (LVEF) <50%. In order for the test to be representative, the maximum time between the performance of the imaging test and the rhythm control procedure will be 3 months, in the absence of intervening cardiovascular events that may have caused a variation in LVEF. In the event that the patient had a previously known LVEF <50%, the change with respect to this attributable to tachyarrhythmia has to be ≥10%.
Signature of informed consent.
Ability to understand and accept participation in the study.
Disqualifiers
Refusal of informed consent.
Legal or juridical incapacity.
Age <18 years.
Life expectancy less than 1 year.
Trial population
Patient with clinical suspected arrhythmia-induced cardiomyopathy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
109 Participants
are grouped into 2 trial groupsGroup A: A
Group B: B
Trial outcomes
Primary outcomes
1
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 yearSecondary outcomes
1
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 year2
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 year3
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 year4
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 yearOther outcomes
1
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 year2
Mortality
Death of any cause. Cardiovascular death will be also asesed
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov