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Clinical Trials/NCT02041832
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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Axel Brandes
Responsible Party
Sponsor Investigator
Principal Investigator

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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