Understanding Arrhythmia-induced Cardiomyopathy
Arrhythmia-induced Cardiomyopathy - a Prospective Observational Cohort Study
This study is trying to learn more about how common arrhythmia-induced heart problems are in patients with weakened heart function and what factors might lead to worse outcomes or hospital visits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT05662293 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather clinical data on patients suspected of having arrhythmia-induced cardiomyopathy (AiCM) at the University Hospital Basel. It includes a retrospective analysis of 1200 patients to determine the incidence of AiCM in those with reduced left ventricular ejection fraction and a prospective cohort of 1500 patients to evaluate predictors of adverse events and re-hospitalizations. Diagnosis will be confirmed by two independent cardiologists using comprehensive clinical data. The study seeks to optimize patient care by establishing the prevalence of AiCM and improving diagnostic criteria.
Who should consider this trial
Good fit: Ideal candidates include adults with a diagnosis or suspicion of arrhythmia-induced cardiomyopathy and reduced left ventricular ejection fraction.
Not a fit: Patients with acute health conditions, terminal illnesses, or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of arrhythmia-induced cardiomyopathy, improving patient outcomes.
How similar studies have performed: While the specific approach of this study is novel, previous studies have highlighted the importance of recognizing and diagnosing arrhythmia-induced cardiomyopathy.
Eligibility criteria
Show full inclusion / exclusion criteria
Prospective part 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 this trial is running
Basel
- University Hospital Basel, Department of Cardiology — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Patrick Badertscher, MD — University Hospital Basel, Department of Cardiology
- Study coordinator: Patrick Badertscher, MD
- Email: patrick.badertscher@usb.ch
- Phone: +41 61 556 58 23
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.