Hypertension Clinical Trial
Official title:
Randomized Controlled Trial to Evaluate Implanted Event Recorders for the First Diagnosis of Atrial Fibrillation in High-risk Patients
Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with
increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient
characteristics increase the likelyhood of AF and at the same time the risk of stroke when
AF has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in
patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease).
However, occasional (paroxysmal) AF may occur without symptoms and remain undetected,
leaving patients at risk.
Aim of the prospective randomized study is to compare two management strategies for patients
at increased risk for AF but without a known history of AF. Patients are seen regularly
(monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of
patients additionally receives a subcutaneous implantation of a loop recorder for continuous
rhythm monitoring, while the control group remains on standard follow-up. Observation period
is one year (optional extension for 3 years). The time to first diagnosis of AF is compared
between groups, blood samples are analyzed for potential biomarkers of AF.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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