NCT02041832CompletedNot Applicable
Detection of Subclinical Atrial Fibrillation in High Risk Patients (> 65 Years, Hypertension, Diabetes Mellitus) Using Implantable Loop Recorder
Axel Brandes2 sites in 1 country82 target enrollmentStarted: October 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 82
- Locations
- 2
- Primary Endpoint
- First episode of atrial fibrillation
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to 90 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Axel Brandes
Associate Professor
Odense University Hospital
Study Sites (2)
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