Back to resultsDetection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder
Primary Purpose
Arterial Hypertension, Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Conventional Holter monitoring
Implantable loop recorder
Sponsored by
About this trial
This is an interventional prevention trial for Arterial Hypertension
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
Sites / Locations
- Haderslev Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Holter monitoring
Implantable loop recorder
Arm Description
Screening of patients with older age, arterial hypertension and diabetes for paroxysmal atrial fibrillation by using conventional Holter monitoring
Screening of patients with older age, arterial hypertension and diabetes mellitus for paroxysmal atrial fibrillation by using an implantable loop recorder
Outcomes
Primary Outcome Measures
First episode of atrial fibrillation
Secondary Outcome Measures
Correlation between echocardiographic parameters and incidence of atrial fibrillation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02041832
Brief Title
Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder
Official Title
Detection of Subclinical Atrial Fibrillation in High Risk Patients (> 65 Years, Hypertension, Diabetes Mellitus) Using Implantable Loop Recorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Axel Brandes
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension, Diabetes Mellitus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Holter monitoring
Arm Type
Other
Arm Description
Screening of patients with older age, arterial hypertension and diabetes for paroxysmal atrial fibrillation by using conventional Holter monitoring
Arm Title
Implantable loop recorder
Arm Type
Other
Arm Description
Screening of patients with older age, arterial hypertension and diabetes mellitus for paroxysmal atrial fibrillation by using an implantable loop recorder
Intervention Type
Other
Intervention Name(s)
Conventional Holter monitoring
Intervention Description
Patients undergo 72h Holter monitoring
Intervention Type
Device
Intervention Name(s)
Implantable loop recorder
Other Intervention Name(s)
REVEAL XT
Intervention Description
Implantation of loop recorder with follow-up by remote monitoring
Primary Outcome Measure Information:
Title
First episode of atrial fibrillation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Correlation between echocardiographic parameters and incidence of atrial fibrillation
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Correlation between biomarkers and incidence of atrial fibrillation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Brandes, Assoc. Prof.
Organizational Affiliation
Odense University Hospital/University of Southern Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Haderslev Hospital
City
Haderslev
ZIP/Postal Code
6100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
29759838
Citation
Philippsen TJ, Christensen LS, Hansen MG, Dahl JS, Brandes A. Detection of Subclinical Atrial Fibrillation in High-Risk Patients Using an Insertable Cardiac Monitor. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1557-1564. doi: 10.1016/j.jacep.2017.06.020. Epub 2017 Nov 6.
Results Reference
derived
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Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder
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