Actively Recruiting
Arrhythmia-induced Cardiomyopathy - a Prospective Observational Cohort Study
Led by University Hospital, Basel, Switzerland · Updated on 2025-03-04
2700
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying arrhythmia-induced cardiomyopathy (AiCM), a heart condition linked to irregular heart rhythms that may cause reduced heart function. This observational study aims to better understand how common AiCM is, improve early diagnosis, and evaluate the current treatments and outcomes for patients suspected of having AiCM. The study includes a retrospective review of past patient data and a prospective follow-up of patients over time. The study involves two parts: a retrospective cohort examining 1200 patients who had reduced heart function and arrhythmias between 2010 and 2021, and a prospective cohort enrolling 1500 patients with suspected AiCM. Diagnosis is confirmed by two cardiologists reviewing clinical data, heart tests, and other assessments. Data collected includes medical history, hospitalizations, heart tests, and patient questionnaires on major heart events and quality of life, with follow-ups up to five years. Participants will provide data through medical record review and questionnaires assessing major cardiovascular events and quality of life at multiple timepoints, including 6 months, 1 year, 2 years, and 5 years. The study tracks incidence of AiCM, adverse heart events, rehospitalizations, and quality of life changes. Monitoring includes ECGs, lab tests, echocardiography, and other cardiac diagnostics. This long-term observation aims to improve understanding of AiCM and its management.
CONDITIONS
Brief Title
Characterization of Arrhythmia-induced Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnostic or suspicion of arrhythmia-induced cardiomyopathy (AiCM) as noted in medical records or identified by cardiology/internal medicine colleagues
- Signed study consent
- Adults aged 18 years or older
- For retrospective part: patients with reduced left-ventricular ejection fraction (LVEF ≤50%) or at least 15% reduction between two echocardiographies and an arrhythmia diagnosis likely leading to AiCM within one year before or after LVEF reduction between 2010-2021
You will not qualify if you...
- Active refusal of general consent for medical data use at University Hospital Basel
- Age under 18 years
- Acute severe health conditions such as recent myocardial infarction, major trauma, sepsis, recent cardiac surgery, or shock
- Life expectancy less than one year due to terminal illness or palliative cancer
- For retrospective part: acute events clearly causing reduced LVEF such as massive myocardial infarction, cardiogenic or septic shock, hypovolemic shock, cardiac arrest requiring resuscitation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial hospital stay and follow-up assessments over several years
Participants undergo diagnostic procedures including ECG, laboratory measurements, vital signs, echocardiography, coronary angiography, stress testing, and other cardiovascular assessments to establish a diagnosis based on expert adjudication.
Visits at baseline, 6 months, 1 year, 2 years, and 5 years
Duration - Up to 5 years
Participants are monitored for adverse cardiovascular events and quality of life through questionnaires and clinical data collection over time.
Questionnaires and assessments at 6 months, 1 year, 2 years, and 5 years via mail, letter, or phone
Trial Site Locations
Total: 1 location
1
University Hospital Basel, Department of Cardiology
Basel, Switzerland, 4031
Actively Recruiting
Research Team
P
Patrick Badertscher, MD
J
Jeanne du Fay de Lavallaz, MD-PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here