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

NCT ID: NCT03541616

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 242 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-24
• Study Completion Date: 2023-03-27

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.

Conditions

Heart Failure; Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Enrolled Patients

ECG Patch, pocket ECG monitor

Intervention Type: DEVICE

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 .

Interventions

ECG 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 .

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role: collaborator

Canadian Cardiovascular Society

OTHER

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge A Wong, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Stuart Connolly, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Juravinski Hospital

Hamilton, Ontario, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

St. Mary's Hospital

Kitchener, Ontario, Canada

St. Catherines General Hospital

St. Catharines, Ontario, Canada

Countries

Canada

Other Identifiers

PROTECT-HF

Identifier Type: -

Identifier Source: org_study_id