Atrial Fibrillation, Heart Failure
Conditions
Brief summary
Multicentre, prospective cohort study in patients with a history of HF with preserved or reduced ejection fraction admitted to hospital with acutely decompensated HF. Eligible and consenting patients will be enrolled at 3 Hamilton, Ontario area hospitals and receive 28-day ECG monitoring implemented at the time of hospital discharge. Patients will be followed for a total of 1 year from hospital discharge.
Detailed description
In patients discharged from hospital after an admission for acute heart failure (HF) decompensation, subclinical atrial fibrillation (AF) of 30 minutes or greater in duration is common (at least 15% of patients without prior AF) and is associated with increased risk of re-hospitalization within 30-days. Study Objectives: 1. To evaluate the prevalence of subclinical AF ≥30 minutes in duration in patients discharged from hospital following an admission for acute HF exacerbation and who have no known history of clinical AF. 2. To examine the temporal association between subclinical AF ≥30 minutes in duration and 30-day hospital readmission for HF.
Interventions
DEVICEECG Patch, pocket ECG monitor
Two consecutive 14-day ECG monitor patches or one single 28-day pocket ECG monitor (28-days total monitoring) implemented at the time of hospital discharge .
Sponsors
Heart and Stroke Foundation of Canada
Canadian Cardiovascular Society
Population Health Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hospitalized with a most responsible diagnosis of acute decompensated heart failure. 2. Clinical signs and symptoms of heart failure as per the Boston criteria (i.e. score ≥8)
Exclusion criteria
1. History of clinical atrial fibrillation 2. History of hypertrophic cardiomyopathy or congenital heart disease. 3. End stage renal disease or advanced renal dysfunction (e.g. estimated glomerular filtration rate, eGFR \< 15 mL/min/1.73 m2) 4. Cardiothoracic surgery in the past 30 days or imminently planned (does not include percutaneous procedures). 5. Unable or unwilling to provide informed consent. 6. Presence of a pacemaker or an ICD with an atrial lead (which can already diagnose AF).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subclinical atrial fibrillation ≥30 minutes in duration | 30 days post-discharge |
Secondary
| Measure | Time frame |
|---|---|
| Heart failure re-hospitalization | 30 days post-discharge |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure re-hospitalization | 1 year post-discharge | — |
| All-cause re-hospitalization | 30 days and 1 year post-discharge | — |
| All-cause and cardiovascular mortality | 30 days and 1 year post-discharge | — |
| Subclinical atrial fibrillation >6 minutes in duration | 30 days post-discharge | — |
| Myocardial infarction | 30 days and 1 year post-discharge | — |
| Patient acceptance of device monitoring | 30 days post-discharge | Measured by simple questionnaire that has not been validated. Patients will be asked to respond to satisfaction questions on a scale of a) strongly agree b) agree c) somewhat agree d) disagree or e) strongly disagree. The questions will ask about their experience with the device, such as: were instructions on using the device clear, the device was easy to use, the device did not limit my usual daily activities, the size of the device was not cumbersome, etc. |
| Incident stroke/TIA or systemic thromboembolism | 30 days and 1 year post-discharge | — |
| Clinical atrial fibrillation | 30 days post-discharge | — |
Countries
Canada
Outcome results
None listed