Prevalence of Subclinical Atrial Fibrillation in Heart Failure Patients and Its Relationship With Hospital Readmission

Completed

• Conditions: Heart Failure; Atrial Fibrillation
• Interventions: Device: ECG Patch, pocket ECG monitor

• Registration Number: NCT03541616
• Lead Sponsor: Population Health Research Institute

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.

Study Timeline

• Study Start: 2018-03-24
• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-30
• Primary Completion: 2022-01-31
• Status Verified: 2023-03
• Study Completion: 2023-03-27
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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)

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled Patients	ECG Patch, pocket ECG monitor	-

Primary Outcome Measures

Name	Time	Method
Subclinical atrial fibrillation ≥30 minutes in duration	30 days post-discharge

Secondary Outcome Measures

Name	Time	Method
Heart failure re-hospitalization	30 days post-discharge

Trial Locations

Locations (5)

St. Mary's Hospital; 🇨🇦 Kitchener, Ontario, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Juravinski Hospital; 🇨🇦 Hamilton, Ontario, Canada

St. Catherines General Hospital; 🇨🇦 St. Catharines, Ontario, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada