Clinical trial NCT02401854: Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly
Hypertension
Risk Factors for Atrial Fibrillation
Keywords: atrial fibrillation
hypertension
risk factors
primary care
elderly
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
name: M-Health Solutions
name: Bristol-Myers Squibb
First posted: 2015-03-30
Enrollment: 129
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly patients attending primary care clinic or ambulatory resident of a chronic care facility, with hypertension and at least one addional risk factor for developing AF.

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.


Eligibility criteria: 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 -

Primary outcomes:
measure: Occurance of atrial fibrillation episode
timeFrame: within 30 - 60 days of follow-up
Secondary outcomes:
measure: Tolerability and feasibility of long term monitoring in elderly patients
timeFrame: 30 - 60 days of follow-up
measure: Proportion of patients eligible to receive anticoagulation
timeFrame: 30 - 60 days of follow-up
measure: AF Burden
timeFrame: 30 - 60 days of follow-up
Other outcomes:
Locations:
city: Burlington
country: Canada
facility: AVIVA Medical Diagnostics and Specialist Clinic Inc.
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group
state: Ontario
city: Hamilton
country: Canada
facility: Family Practice - Drs. Cameron, Crombie & Croft
state: Ontario
city: Oakville
country: Canada
facility: OakMed Family Health Team
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Jeff Healey, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: Stuart Connolly, M.D.
role: PRINCIPAL_INVESTIGATOR
References: