Arterial Hypertension, Diabetes Mellitus
Conditions
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.
Interventions
OTHERConventional Holter monitoring
Patients undergo 72h Holter monitoring
DEVICEImplantable loop recorder
Implantation of loop recorder with follow-up by remote monitoring
Sponsors
Axel Brandes
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First episode of atrial fibrillation | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between echocardiographic parameters and incidence of atrial fibrillation | 1 year |
Other
| Measure | Time frame |
|---|---|
| Correlation between biomarkers and incidence of atrial fibrillation | 1 year |
Countries
Denmark
Outcome results
None listed