Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder

Completed

• Conditions: Hypertension; Risk Factors for Atrial Fibrillation; Elderly

• Registration Number: NCT02401854
• Lead Sponsor: Population Health Research Institute

Brief Summary

The ASSERT-III study aims to determine the incidence of sub-clinical (silent) atrial fibrillation (AF) among elderly patients with hypertension and at least one other risk factor for AF. This will be accomplished by monitoring with a wireless external loop monitor for 30 to 60 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-11-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-30
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

Patients will be eligible for inclusion if they meet all of the following:

1. Age ≥ 80 years

2. History of hypertension OR a blood pressure of ≥ 140/90 mmHg

3. Attending a primary care clinic, OR ambulatory resident of a chronic care facility

4. At least one of the following additional risk factors for developing AF:

   1. Diabetes
   2. Body mass index ≥ 30
   3. History of smoking
   4. Documented Obstructive sleep apnea
   5. Cardiovascular disease
   6. Heart Failure
   7. Left ventricular hypertrophy (on ECG or echocardiography)

5. Provide written informed consent

Exclusion Criteria

1. ECG documented history of AF or atrial flutter, with an episode duration ≥ 6 minutes

2. Existing implanted pacemaker or defibrillator

3. Patients considered by the investigator to be unsuitable for study follow-up because the patient:

   1. is unreliable concerning the requirements for follow-up during the study and/or compliance with the use of the external loop recorder
   2. has a life expectancy less that the expected study duration due to concomitant disease
   3. has a condition which in the opinion of the investigator, would not allow current chronic treatment with anticoagultion -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurance of atrial fibrillation episode	within 30 - 60 days of follow-up	Detection rate of sub-clinical atrial fibrillation episodes, at least 6 minutes in duration

Secondary Outcome Measures

Name	Time	Method
Proportion of patients eligible to receive anticoagulation	30 - 60 days of follow-up
AF Burden	30 - 60 days of follow-up	An estimate of the burden of atrial arrhythmias (from device logs) in patients with AF.
Tolerability and feasibility of long term monitoring in elderly patients	30 - 60 days of follow-up	The tolerability of long-term monitoring in elderly patients and the ability of these patients to manually transmit data to the cardiac analyses centre.

Trial Locations

Locations (4)

Hamilton Medical Research Group; 🇨🇦 Hamilton, Ontario, Canada

AVIVA Medical Diagnostics and Specialist Clinic Inc.; 🇨🇦 Burlington, Ontario, Canada

Family Practice - Drs. Cameron, Crombie & Croft; 🇨🇦 Hamilton, Ontario, Canada

OakMed Family Health Team; 🇨🇦 Oakville, Ontario, Canada