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

NCT03541616 | Completed

• 1 other identifier: PROTECT-HF
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 5

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.

Conditions

Heart Failure; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Subclinical atrial fibrillation ≥30 minutes in duration

  30 days post-discharge

Secondary Outcomes (1)

• Heart failure re-hospitalization

  30 days post-discharge

Other Outcomes (8)

• Subclinical atrial fibrillation >6 minutes in duration

  30 days post-discharge

• Clinical atrial fibrillation

  30 days post-discharge

• Heart Failure re-hospitalization

  1 year post-discharge

Study Arms (1)

Enrolled Patients

Device: ECG Patch, pocket ECG monitor

Interventions

ECG Patch, pocket ECG monitor 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 .

Enrolled Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Hospitalized with a most responsible diagnosis of acute decompensated heart failure.
• Clinical signs and symptoms of heart failure as per the Boston criteria (i.e. score ≥8)

You may not qualify if:

• History of clinical atrial fibrillation
• History of hypertrophic cardiomyopathy or congenital heart disease.
• End stage renal disease or advanced renal dysfunction (e.g. estimated glomerular filtration rate, eGFR \< 15 mL/min/1.73 m2)
• Cardiothoracic surgery in the past 30 days or imminently planned (does not include percutaneous procedures).
• Unable or unwilling to provide informed consent.
• Presence of a pacemaker or an ICD with an atrial lead (which can already diagnose AF).

Sponsors & Collaborators

• Population Health Research Institute: lead
• Heart and Stroke Foundation of Canada: collaborator
• Canadian Cardiovascular Society: collaborator

Study Sites (5)

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Juravinski Hospital

Hamilton, Ontario, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Location

St. Mary's Hospital

Kitchener, Ontario, N2M1B2, Canada

Location

St. Catherines General Hospital

St. Catharines, Ontario, L2S0A9, Canada

Location

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jorge A Wong, MD, MPH

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Stuart Connolly, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 30, 2018
• Study Start: March 24, 2018
• Primary Completion: January 31, 2022
• Study Completion: March 27, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)