Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder

Axel Brandes

Status: Completed

Conditions: Diabetes Mellitus; Arterial Hypertension

Treatments: Device: Implantable loop recorder; Other: Conventional Holter monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02041832

S-20130062 (Other Identifier)

ILR-Afib-study

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Holter monitoring

Other group

Description:

Screening of patients with older age, arterial hypertension and diabetes for paroxysmal atrial fibrillation by using conventional Holter monitoring

Treatment:

Other: Conventional Holter monitoring

Implantable loop recorder

Other group

Description:

Screening of patients with older age, arterial hypertension and diabetes mellitus for paroxysmal atrial fibrillation by using an implantable loop recorder

Treatment:

Device: Implantable loop recorder