NCT02041832
Completed
Not Applicable
Detection of Subclinical Atrial Fibrillation in High Risk Patients (> 65 Years, Hypertension, Diabetes Mellitus) Using Implantable Loop Recorder
Axel Brandes1 site in 1 country82 target enrollmentOctober 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arterial Hypertension
- Sponsor
- Axel Brandes
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- First episode of atrial fibrillation
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Using implantable loop recorder the investigators wish to detect atrial fibrillation in high risk patients and compare it to the results using conventional Holter monitoring. The hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The investigators want to detect those people so they can receive appropriate anticoagulation treatment. The patients will get a comprehensive workup including ecg, echocardiography and blood tests.
Investigators
Axel Brandes
Associate Professor
Odense University Hospital
Eligibility Criteria
Inclusion Criteria
- •age \> 65 years
- •arterial hypertension (at least dual treatment)
- •diabetes mellitus (oral antidiabetics or insulin)
Exclusion Criteria
- •known atrial fibrillation
- •ischaemic heart disease
- •Current anticoagulation treatment
- •Ejection fraction \<45 %
- •significant valvular heart disease
- •previous stroke/transient ischemic attack
- •peripheral arterial disease
- •end stage renal disease
- •thyreotoxicosis
Outcomes
Primary Outcomes
First episode of atrial fibrillation
Time Frame: 1 year
Secondary Outcomes
- Correlation between echocardiographic parameters and incidence of atrial fibrillation(1 year)
Study Sites (1)
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