RecruitingNCT05662293

Characterization of Arrhythmia-induced Cardiomyopathy

Arrhythmia-induced Cardiomyopathy - a Prospective Observational Cohort Study

Sponsor

University Hospital, Basel, Switzerland

Enrollment

2,700 participants

Start Date

Jun 10, 2021

Study Type

OBSERVATIONAL

Conditions

Cardiomyopathy Arrhythmia-induced Cardiomyopathy (AiCM)

Summary

The goal of the this observational study is to gather clinically available data on patients presenting with a suspicion for arrhythmia-induced cardiomyopathy (AiCM) at the University Hospital Basel.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Prospective part
Diagnostic or suspicion of AiCM as presence of specified keyword in patient's file or as screened by colleagues of the internal medicine or cardiology clinics
Signed study consent
Patients with a reduced left-ventricular ejection fraction (LVEF ≤50%) or a reduction of 15% in the ejection fraction (EF) between two echocardiographies and a concomitant diagnosis of any arrhythmia likely to lead to AiCM within one year before or after diagnosis of the reduced LVEF from 2010-2021

Exclusion Criteria8

Patient's active refusal of the general consent of the University Hospital Basel
Age \<18 years old
Life expectancy \<1 year (palliative, terminal cancer)
Retrospective part
Age \< 18 years old
Patient's active refusal of the general consent of the University Hospital Basel
Acute event clearly leading to an acutely reduced LVEF (massive type I myocardial infarction, cardiogenic shock from a coronary or myocardial etiology, septic shock leading to toxic myopathy, hypovolemic shock with reduced EF, cardiac arrest and/or need for resuscitation).
Patients with life expectancy \<1 year (palliative, terminal cancer)

Interventions

OTHERData collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part)

Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part). The assessment will be done via mail, letter or phone

OTHERData collection: Quality of Life (QoL) Questionnaire (prospective part)

Data collection: Quality of Life (QoL) Questionnaire (prospective part). The questionnaire "EQ-5D-5L questionnaire" will be used to assess quality of life.

OTHERData collection (retrospective study)

Anonymized search and review of patients electronic health records of the University Hospital of Basel for patients with a reduced LVEF and a concomitant (±1year or after any observation of a reduced LVEF in imaging) diagnosis of arrhythmia known to be causing AiCM.

OTHERData collection (prospective study database)

Data collection on alcohol consumption, family history, rhythm disorder, hospitalizations, cardiac assessments, adverse events at baseline, 6 months, 1 year, 2 years and 5 years.