Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy
Launched by HOSPITAL UNIVERSITARIO 12 DE OCTUBRE · Mar 19, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a condition called arrhythmia-induced cardiomyopathy (AiCM), which occurs when abnormal heart rhythms lead to heart muscle weakness. The researchers want to understand if people with AiCM have more genetic mutations compared to those with other heart conditions or the general population. They are also interested in whether these genetic factors can help predict how the condition will progress in patients.
To participate in this study, individuals should be between the ages of 65 and 74 and have a diagnosis of atrial fibrillation or atrial flutter, which are types of irregular heartbeats. They must have undergone a heart imaging test that shows their heart's pumping ability is below a certain level. Participants will be asked to sign a consent form and have regular follow-ups. It’s important to note that some people may not be eligible, such as those under 18, those with other serious heart conditions, or those who cannot commit to follow-up visits. If you or a loved one is interested, this study could offer valuable insights into the genetic aspects of AiCM and its future treatment options.
Gender
ALL
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.
About Hospital Universitario 12 De Octubre
Hospital Universitario 12 de Octubre is a leading academic medical center located in Madrid, Spain, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical research, the hospital integrates cutting-edge medical practices with a robust educational environment, fostering collaboration among healthcare professionals, researchers, and patients. With a focus on improving patient outcomes and contributing to medical knowledge, the hospital actively participates in a diverse range of clinical trials across various therapeutic areas, ensuring adherence to the highest ethical standards and regulatory guidelines. Its dedication to excellence in clinical research positions Hospital Universitario 12 de Octubre as a pivotal institution in the advancement of medical science and patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
Madrid, , Spain
Ciudad Ream, Madrid, Spain
Albacete, , Spain
Ciudad Real, Castilla La Mancha, Spain
Patients applied
Trial Officials
Martín Negreira-Caamaño, MD, PhD
Study Director
Cardiology department, 12 de Octubre University Hospital
Rafael Salguero-Bodes, MD
Study Director
Cardiology Department, 12 de Octubre University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported