Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy

NCT06896266 | Recruiting

• 1 other identifier: 24/391
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 4

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?

Conditions

Arrhythmia; Cardiomyopathy; Arrhythmia-induced Cardiomyopathy (AiCM)

Keywords

atrial fibrillation; atrial flutter; heart failure; arrhythmia-induced cardiomyopathy; cardiomyopathy; genetics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Heart Failure Admission

  Through study completion, an average of 1 year

• Arrhythmia recurrence

  Through study completion, an average of 1 year

• New unplanned rhythm control procedure

  Through study completion, an average of 1 year

• Atrial reverse remodelling

  Through study completion, an average of 1 year

Other Outcomes (2)

• Cardiovascular Hospitalization

  Through study completion, an average of 1 year

• Mortality

  Through study completion, an average of 1 year

Study Arms (2)

A

Patients with arrhytmia-induced cardiomyopathy criteria

B

Patients without arrhytmia-induced cardiomyopathy criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with clinical suspected arrhythmia-induced cardiomyopathy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead

Study Sites (4)

Ciudad Real General University Hospital

Ciudad Real, Castille-La Mancha, 15004, Spain

RECRUITING

12 de Octubre University Hospital

Madrid, Madrid, 28004, Spain

RECRUITING

Albacete University Hospital Complex

Albacete, Spain

NOT YET RECRUITING

Ramón y Cajal University Hospital

Madrid, Spain

ACTIVE NOT RECRUITING

Related Publications (2)

• 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.

  PMID: 38693772 BACKGROUND

• 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.

  PMID: 38811098 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Arrhythmias, Cardiac; Cardiomyopathies; Atrial Fibrillation; Atrial Flutter; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Central Study Contacts

Martín Negreira-Caamaño, MD, PhD

CONTACT

+34913908000; martin.negcam@gmail.com

Daniel Rodríguez-Muñoz, MD, PhD

CONTACT

+34913908000; daniel.rodriguez.mnz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 26, 2025
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

ES (4)