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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Patients with arrhytmia-induced cardiomyopathy criteria | ||
| B | Patients without arrhytmia-induced cardiomyopathy criteria |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of pathogenic or likely pathogenic variants in genetic test | Presence of pathogenic/likely pathogenic genetic variant in genetic test | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure Admission | Incidence of new hospitalización or urgent visit due to heart failure requiring intravenous diuretics | Through study completion, an average of 1 year |
| Arrhythmia recurrence |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Hospitalization | Incidence of unplanned hospital admission due to a cardiovascular aethiology, including acute coronary syndrome, rhythm disorder, heart failure, valvular heart disease, cardiogenic syncope, ischaemic stroke or transient ischaemic attack, acute aortic syndrome, pulmonary or systemic embolism or unexplained sudden cardiac death. | Through study completion, an average of 1 year |
Inclusion Criteria:
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:
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Patient with clinical suspected arrhythmia-induced cardiomyopathy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martín Negreira-Caamaño, MD, PhD | Contact | +34913908000 | martin.negcam@gmail.com | |
| Daniel Rodríguez-Muñoz, MD, PhD | Contact | +34913908000 | daniel.rodriguez.mnz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Martín Negreira-Caamaño, MD, PhD | Cardiology department, 12 de Octubre University Hospital | Study Director |
| Rafael Salguero-Bodes, MD | Cardiology Department, 12 de Octubre University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ciudad Real General University Hospital | Recruiting | Ciudad Real | Castille-La Mancha | 15004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38693772 | Result | Serban T, Badertscher P, du Fay de Lavallaz J, Providencia R, Migliore F, Mugnai G, Penela D, Perrotta L, Kuhne M, Sticherling C, Chun KJ. Definition and management of arrhythmia-induced cardiomyopathy: findings from the European Heart Rhythm Association survey. Europace. 2024 May 2;26(5):euae112. doi: 10.1093/europace/euae112. | |
| 38811098 |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D009202 | Cardiomyopathies |
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Blood samples
Incidence of any atrial tachyarrhytmia (Atrial fibrillation, atrial flutter or atrial tachycardia) conditioning an atrial rate >150 beats per minute and with a duration of >5 minutes.
| Through study completion, an average of 1 year |
| New unplanned rhythm control procedure | Incidence of unplanned electrical cardioversion or catheter ablation of an atrial tachyarrhythmia (Atrial fibrillation, atrial flutter or atrial tachycardia) | Through study completion, an average of 1 year |
| Atrial reverse remodelling | Incidence of atrial reverse remodelling (ARR). ARR will be considered with a decrease in >1 degree of atrial dilatation (0=non dilated; 1= mild; 2=moderate; 3=severe) or a decrease >15% in the left atrial indexed volume | Through study completion, an average of 1 year |
| Mortality | Death of any cause. Cardiovascular death will be also asesed | Through study completion, an average of 1 year |
| 12 de Octubre University Hospital | Recruiting | Madrid | Madrid | 28004 | Spain |
|
| Albacete University Hospital Complex | Not yet recruiting | Albacete | Spain |
|
| Ramón y Cajal University Hospital | Active, not recruiting | Madrid | Spain |
| Shoureshi P, Tan AY, Koneru J, Ellenbogen KA, Kaszala K, Huizar JF. Arrhythmia-Induced Cardiomyopathy: JACC State-of-the-Art Review. J Am Coll Cardiol. 2024 Jun 4;83(22):2214-2232. doi: 10.1016/j.jacc.2024.03.416. |