Prevalence of Subclinical Atrial Fibrillation in Heart Failure Patients and Its Relationship With Hospital Readmission (PROTECT-HF)

Prevalence of Subclinical Atrial Fibrillation in High Risk Heart Failure Patients and Its Temporal Relationship With Hospital Readmission for Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Atrial Fibrillation
• Intervention / Treatment: Device: ECG Patch, pocket ECG monitor

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 Type: Observational
• Enrollment (Actual): 242

Contacts and Locations

• Study Contact: Name: Elham Ramezani, M.Sc; Phone Number: 289-208-4694; Email: protect-hf@phri.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Hamilton General Hospital
    • Hamilton, Ontario, Canada
      • Juravinski Hospital
    • Hamilton, Ontario, Canada
      • St. Joseph's Healthcare Hamilton
    • Kitchener, Ontario, Canada, N2M1B2
      • St. Mary's Hospital
    • St. Catharines, Ontario, Canada, L2S0A9
      • St. Catherines General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enrolled Patients	Device: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subclinical atrial fibrillation ≥30 minutes in duration	30 days post-discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart failure re-hospitalization	30 days post-discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
All-cause re-hospitalization		30 days and 1 year post-discharge
All-cause and cardiovascular mortality		30 days and 1 year post-discharge
Incident stroke/TIA or systemic thromboembolism		30 days and 1 year post-discharge
Myocardial infarction		30 days and 1 year post-discharge
Patient acceptance of device monitoring	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.	30 days post-discharge

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: Heart and Stroke Foundation of Canada; Canadian Cardiovascular Society
• Investigators: Principal Investigator: Jorge A Wong, MD, MPH, Population Health Research Institute; Principal Investigator: Stuart Connolly, MD, Population Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2018
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): March 27, 2023

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: PROTECT-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No