Status:
RECRUITING
Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy
Lead Sponsor:
Hospital Universitario 12 de Octubre
Conditions:
Arrhythmia
Cardiomyopathy
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT06896266
Start Date
December 1 2024
End Date
December 1 2026
Last Update
May 14 2025
Active Locations (4)
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1
Ciudad Real General University Hospital
Ciudad Real, Castille-La Mancha, Spain, 15004
2
12 de Octubre University Hospital
Madrid, Madrid, Spain, 28004
3
Albacete University Hospital Complex
Albacete, Spain
4
Ramón y Cajal University Hospital
Madrid, Spain