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

Heart Failure Clinical Trial

— PROTECT-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541616
• Other study ID #: PROTECT-HF
• Status: Completed
• Start date: March 24, 2018
• Est. completion date: March 27, 2023

Study information

• Verified date: March 2023
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: March 27, 2023
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

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 .

Locations

Country	Name	City	State
Canada	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

Sponsors (3)

Lead Sponsor	Collaborator
Population Health Research Institute	Canadian Cardiovascular Society, Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subclinical atrial fibrillation >6 minutes in duration		30 days post-discharge
Other	Clinical atrial fibrillation		30 days post-discharge
Other	Heart Failure re-hospitalization		1 year post-discharge
Other	All-cause re-hospitalization		30 days and 1 year post-discharge
Other	All-cause and cardiovascular mortality		30 days and 1 year post-discharge
Other	Incident stroke/TIA or systemic thromboembolism		30 days and 1 year post-discharge
Other	Myocardial infarction		30 days and 1 year post-discharge
Other	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
Primary	Subclinical atrial fibrillation =30 minutes in duration		30 days post-discharge
Secondary	Heart failure re-hospitalization		30 days post-discharge