Definition and management of arrhythmia-induced cardiomyopathy: findings from the European Heart Rhythm Association survey.
Teodor Serban, Patrick Badertscher, Jeanne du Fay de Lavallaz...
https://pubmed.ncbi.nlm.nih.gov/38693772Actively Recruiting
Age: 18Years +
All Genders
ID06896266
Understanding and Characterizing the Genetics of Patients With Arrhythmia-Induced Cardiomyopathy
Led by Hospital Universitario 12 de Octubre · Updated on 2025-05-14
109
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the genetic aspects of arrhythmia-induced cardiomyopathy (AiC), a condition where a new arrhythmia causes reduced heart pumping function. This observational study aims to understand whether patients with AiC have more genetic mutations compared to other cardiomyopathy types or the general population, and whether genetics affect the outlook for these patients. The study includes patients suspected of AiC undergoing rhythm control procedures like electric cardioversion or catheter ablation. Participants will be followed for one year after these procedures, with genetic testing conducted to identify variants in genes related to cardiomyopathy. Follow-up visits occur at 2, 6, and 12 months, including electrocardiograms and heart imaging to monitor heart function and remodeling. Participants will have their heart rhythm and left ventricular function evaluated over time to confirm AiC and assess recovery. The study measures the presence of harmful genetic variants, heart failure admissions, arrhythmia recurrence, additional rhythm control procedures, and heart remodeling changes. The research team will observe clinical events and genetic links to the condition during the one-year follow-up period.
CONDITIONS
Brief Title
Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Presence of atrial fibrillation or atrial flutter not self-limited
- Cardiac imaging test showing left ventricular ejection fraction (LVEF) below 50% within 3 months before rhythm control procedure
- If previously known LVEF below 50%, must have at least 10% change due to tachyarrhythmia
- Signed informed consent
- Ability to understand and accept participation in the study
You will not qualify if you...
- Refusal to provide informed consent
- Legal or juridical incapacity
- Age under 18 years
- Life expectancy less than 1 year
- Inability to have at least 6 months follow-up
- Ventricular rate above 140 beats per minute affecting imaging validity
- Known causes of systolic ventricular dysfunction such as prior cardiomyopathy diagnosis
- Severe mitral or aortic valve disease
- Non-revascularizable ischemic heart disease
- Cardiopulmonary resuscitation context
- Abusive alcohol consumption over 80 grams ethanol or 7 standard drinks daily
- Active chemotherapy or thorax radiation therapy
- Known infection with agents causing cardiomyopathy like Trypanosoma cruzi or Borrellia burgdorferi
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 3 months before rhythm control procedure
Participants undergo genetic testing and cardiac imaging to assess genetic variants and heart function related to arrhythmia-induced cardiomyopathy.
1 genetic test and imaging session
Monitoring
Duration - 1 year
Participants are followed for 1 year after the rhythm control procedure to monitor rhythm control status, cardiac remodeling, and clinical events.
Follow-up visits at 2, 6, and 12 months including electrocardiogram and echocardiography
Trial Site Locations
Total: 4 locations
1
Ciudad Real General University Hospital
Ciudad Real, Castille-La Mancha, Spain, 15004
Actively Recruiting
2
12 de Octubre University Hospital
Madrid, Madrid, Spain, 28004
Actively Recruiting
3
Albacete University Hospital Complex
Albacete, Spain
Not Yet Recruiting
4
Ramón y Cajal University Hospital
Madrid, Spain
Active, Not Recruiting
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Research Team
M
Martín Negreira-Caamaño, MD, PhD
D
Daniel Rodríguez-Muñoz, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Arrhythmia-Induced Cardiomyopathy: JACC State-of-the-Art Review.
Pouria Shoureshi, Alex Y Tan, Jayanthi Koneru...
https://pubmed.ncbi.nlm.nih.gov/38811098