Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy

Recruiting now

Conditions studied: Arrhythmia, Cardiomyopathy, Arrhythmia-induced Cardiomyopathy (AiCM)

In brief

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?

Key facts

Study ID

NCT06896266

Run by

Hospital Universitario 12 de Octubre

People needed

109

Starts

2024-12-01

Expected to finish

2026-12-01

Last updated by the study team

2025-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Refusal of informed consent.
• Legal or juridical incapacity.
• Age <18 years.
• Life expectancy less than 1 year.
• Impossibility of a follow-up of at least 6 months.
• Presence of a ventricular rate >140 beats per minute, limiting the validity of imaging measurements.
• Presence of known factors causing systolic ventricular dysfunction:
• Prior cardiomyopathy diagnosis.
• Severe mitral or aortic valve disease.
• Non-revascularizable ischemic heart disease.
• Context of peri-resuscitation cardiopulmonary care.
• Abusive alcohol consumption, defined as >80 grams of ethanol or >7 standard alcoholic beverages per day.
• Active treatment with chemotherapeutic agents or radiation therapy to the thorax.
• Known infection with Trypanosoma cruzi, Borrellia burgdorferi or other infectious agent causing cardiomyopathy.

Where it is running

• Ciudad Real General University Hospital — Ciudad Real, Castille-La Mancha, Spain (enrolling)
• 12 de Octubre University Hospital — Madrid, Madrid, Spain (enrolling)
• Albacete University Hospital Complex — Albacete, Spain
• Ramón y Cajal University Hospital — Madrid, Spain

Full record on ClinicalTrials.gov

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