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

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

Sponsors

Lead sponsor: Population Health Research Institute

Collaborator: Heart and Stroke Foundation of Canada
Canadian Cardiovascular Society

Source 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.

Overall Status Recruiting
Start Date March 24, 2018
Completion Date November 30, 2020
Primary Completion Date October 30, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Subclinical atrial fibrillation ≥30 minutes in duration 30 days post-discharge
Secondary Outcome
Measure Time Frame
Heart failure re-hospitalization 30 days post-discharge
Enrollment 240
Condition
Intervention

Intervention type: Device

Intervention name: ECG Patch, pocket ECG monitor

Description: 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 .

Arm group label: Enrolled Patients

Eligibility

Sampling method: Non-Probability Sample

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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Nazneen Solkar Nazneen Solkar Nazneen Solkar
289-208-4694 289-208-4694 289-208-4694
[email protected] [email protected] [email protected]
Overall Contact

Last name: Nazneen Solkar

Phone: 289-208-4694

Email: [email protected]

Location
facility status contact
Hamilton General Hospital Recruiting Jorge Wong, MD
Juravinski Hospital Recruiting Ameen Patel, MD
St. Joseph's Healthcare Hamilton Recruiting David Conen, MD
St. Mary's Hospital Not yet recruiting
Location Countries

Canada

Verification Date

January 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Enrolled Patients

Acronym PROTECT-HF
Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov