NCT06896266

Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy

Understanding and Characterizing the Genetics of Patients With Arrhythmia-Induced Cardiomyopathy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 109 (estimated)
• Sponsor: Hospital Universitario 12 de Octubre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Detailed description

This is a multicentric prospective observational study including patients with suspected arrhythmia-induced cardiomyopathy (AiC) and undergoing rhythm control strategy. AiC suspicion is defined by the presence of left ventricular ejection fraction \<50% with no other more plausible explanation than a new-onset arrhythmia. Patients who met the inclusion/exclusion criteria will be followed during 1 year after the rhythm control procedure (electric cardioversion or catheter ablation) to asess rhythm control status, imaging remodeling and clinical events. A genetic test will be performed during the study time to asess the existace of genetic variants in cardiomyopathy-related genes. Follow-up visits will be scheduled at 2, 6 and 12 months after inclusion and electrocardiogram and echocardiography will be performed. AiC will be confirmed in case of left ventricular ejection fraction recovery \>10% or absolute value \>54% during the follow up imaging evaluations. Primary analysis will asess the prevalence of pathogenic /likely patogenic variants in patients fullfilling AiC criteria and compared with those who not (without AiC). Secondary analysis will be focused on the incidence of cardiovascular events (heart failure-related and rhythm control-related) during the follow up and its relationship with the genetic background and the AiC status. Imaging test during follow up will be performed and changes in ventricular and atrial parameters will be used to asess cardiac remodeling. Further rhythm control asessment will be performed following routinary clinical practice in each participant center.

Conditions

• Arrhythmia
• Cardiomyopathy
• Arrhythmia-induced Cardiomyopathy (AiCM)

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2025-03-26
• Last updated: 2025-05-14

Locations

4 sites across 1 country: Spain