Understanding the genetics of arrhythmia-induced cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the genetic characteristics of patients diagnosed with arrhythmia-induced cardiomyopathy (AiC) and assess its clinical prognosis. It will include patients with suspected AiC who are undergoing rhythm control strategies, such as electric cardioversion or catheter ablation. Participants will be monitored for one year post-procedure, with genetic testing and follow-up imaging to evaluate heart function and any cardiovascular events. The study seeks to determine the prevalence of genetic mutations in AiC patients compared to other cardiomyopathy types and their prognostic significance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Ciudad Real General University Hospital
  Ciudad Real, Castille-La Mancha, Spain Recruiting
• 12 de Octubre University Hospital
  Madrid, Madrid, Spain Recruiting
• Albacete University Hospital Complex
  Albacete, Spain Not yet recruiting
• Ramón y Cajal University Hospital
  Madrid, Spain Active not recruiting

Study contacts

• Study coordinator: Martín Negreira-Caamaño, MD, PhD
• Email: martin.negcam@gmail.com
• Phone: +34913908000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.