Clinical trial NCT03541616: Prevalence of Subclinical Atrial Fibrillation in Heart Failure Patients and Its Relationship With Hospital Readmission
Official title: Prevalence of Subclinical Atrial Fibrillation in High Risk Heart Failure Patients and Its Temporal Relationship With Hospital Readmission for Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Atrial Fibrillation
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: Canadian Cardiovascular Society
First posted: 2018-05-30
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a history of HF who are admitted to hospital with acutely decompensated HF and have no prior history of AF.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Subclinical atrial fibrillation ≥30 minutes in duration
timeFrame: 30 days post-discharge
Secondary outcomes:
measure: Heart failure re-hospitalization
timeFrame: 30 days post-discharge
Other outcomes:
measure: Subclinical atrial fibrillation >6 minutes in duration
timeFrame: 30 days post-discharge
measure: Clinical atrial fibrillation
timeFrame: 30 days post-discharge
measure: Heart Failure re-hospitalization
timeFrame: 1 year post-discharge
measure: All-cause re-hospitalization
timeFrame: 30 days and 1 year post-discharge
measure: All-cause and cardiovascular mortality
timeFrame: 30 days and 1 year post-discharge
measure: Incident stroke/TIA or systemic thromboembolism
timeFrame: 30 days and 1 year post-discharge
measure: Myocardial infarction
timeFrame: 30 days and 1 year post-discharge
measure: Patient acceptance of device monitoring
timeFrame: 30 days post-discharge
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Kitchener
country: Canada
facility: St. Mary's Hospital
state: Ontario
city: St. Catharines
country: Canada
facility: St. Catherines General Hospital
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Jorge A Wong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: Stuart Connolly, MD
role: PRINCIPAL_INVESTIGATOR
References: