Characterization of Arrhythmia-induced Cardiomyopathy
Recruiting · NCT05662293 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital, Basel, Switzerland
View the official record on ClinicalTrials.gov →Interventions studied
Data collection (prospective study database)Data collection (retrospective study)Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part)Data collection: Quality of Life (QoL) Questionnaire (prospective part)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- Patient's active refusal of the general consent of the University Hospital Basel
- Age \<18 years old
- Temporary exclusion criteria: Acute health condition such as myocardial infarction, patients presenting with a major trauma, a sepsis, patients shortly after cardiac surgery, and patients in shock (\>100 bpm, \<90 systolic BP, evidence of organ dysfunction).
- Life expectancy \<1 year (palliative, terminal cancer)
- Retrospective part
- Inclusion Criteria:
- 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 Criteria:
- 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)
Where it is running
1 location listed.
- University Hospital Basel, Department of Cardiology - Basel, Switzerland