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

Diabetes Mellitus Clinical Trial

Official title:

Detection of Subclinical Atrial Fibrillation in High Risk Patients (> 65 Years, Hypertension, Diabetes Mellitus) Using Implantable Loop Recorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041832
• Other study ID #: ILR-Afib-study
• Secondary ID: S-20130062
• Status: Completed
• Phase: N/A
• First received: November 28, 2013
• Last updated: September 27, 2016
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arterial Hypertension
• Atrial Fibrillation
• Diabetes Mellitus
• Hypertension

Intervention

Other:
• Conventional Holter monitoring
Patients undergo 72h Holter monitoring

Device:
• Implantable loop recorder
Implantation of loop recorder with follow-up by remote monitoring

Locations

Country	Name	City	State
Denmark	Haderslev Hospital	Haderslev

Sponsors (1)

Lead Sponsor	Collaborator
Axel Brandes

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between biomarkers and incidence of atrial fibrillation		1 year	No
Primary	First episode of atrial fibrillation		1 year	No
Secondary	Correlation between echocardiographic parameters and incidence of atrial fibrillation		1 year	No