NCT06896266 Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy
| NCT ID | NCT06896266 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario 12 de Octubre |
| Condition | Arrhythmia |
| Study Type | OBSERVATIONAL |
| Enrollment | 109 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 109 participants in total. It began in 2024-12-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Martín Negreira-Caamaño, MD, PhD
STUDY DIRECTOR
Cardiology department, 12 de Octubre University Hospital
Frequently Asked Questions
Who can join the NCT06896266 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arrhythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06896266 currently recruiting?
Yes, NCT06896266 is actively recruiting participants. Contact the research team at martin.negcam@gmail.com for enrollment information.
Where is the NCT06896266 trial being conducted?
This trial is being conducted at Ciudad Real, Spain, Madrid, Spain, Albacete, Spain, Madrid, Spain.
Who is sponsoring the NCT06896266 clinical trial?
NCT06896266 is sponsored by Hospital Universitario 12 de Octubre. The principal investigator is Martín Negreira-Caamaño, MD, PhD at Cardiology department, 12 de Octubre University Hospital. The trial plans to enroll 109 participants.