Understanding the genetics of arrhythmia-induced cardiomyopathy
Understanding and Characterizing the Genetics of Patients With Arrhythmia-Induced Cardiomyopathy
This study is trying to see if certain genetic traits in people with arrhythmia-induced cardiomyopathy can help predict their heart health and outcomes after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 109 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Drugs / interventions | radiation |
| Locations | 4 sites (Ciudad Real, Castille-La Mancha and 3 other locations) |
| Trial ID | NCT06896266 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with atrial fibrillation or flutter and a left ventricular ejection fraction below 50%.
Not a fit: Patients with a life expectancy of less than one year or those unable to commit to follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of arrhythmia-induced cardiomyopathy through genetic insights.
How similar studies have performed: While genetic studies in cardiomyopathy are ongoing, this specific focus on arrhythmia-induced cardiomyopathy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ciudad Real, Castille-La Mancha and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.