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

Hypertension Clinical Trial

— ASSERT-III  

Official title:

Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder Using Automatic Algorithms for AF Detection: A Pilot Study (ASSERT-III)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401854
• Other study ID #: ASSERT-III
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: April 27, 2015
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 80 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Elderly
• Hypertension
• Risk Factors for Atrial Fibrillation

Locations

Country	Name	City	State
Canada	AVIVA Medical Diagnostics and Specialist Clinic Inc.	Burlington	Ontario
Canada	Family Practice - Drs. Cameron, Crombie & Croft	Hamilton	Ontario
Canada	Hamilton Medical Research Group	Hamilton	Ontario
Canada	OakMed Family Health Team	Oakville	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Population Health Research Institute	Bristol-Myers Squibb, M-Health Solutions, Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurance of atrial fibrillation episode	Detection rate of sub-clinical atrial fibrillation episodes, at least 6 minutes in duration	within 30 - 60 days of follow-up	No
Secondary	Tolerability and feasibility of long term monitoring in elderly patients	The tolerability of long-term monitoring in elderly patients and the ability of these patients to manually transmit data to the cardiac analyses centre.	30 - 60 days of follow-up	No
Secondary	Proportion of patients eligible to receive anticoagulation		30 - 60 days of follow-up	No
Secondary	AF Burden	An estimate of the burden of atrial arrhythmias (from device logs) in patients with AF.	30 - 60 days of follow-up	No