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

March 29, 2023 updated by: Population Health Research Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
242

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Subclinical atrial fibrillation ≥30 minutes in duration
Time Frame: 30 days post-discharge
30 days post-discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Heart failure re-hospitalization
Time Frame: 30 days post-discharge
30 days post-discharge

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subclinical atrial fibrillation >6 minutes in duration
Time Frame: 30 days post-discharge
30 days post-discharge
Clinical atrial fibrillation
Time Frame: 30 days post-discharge
30 days post-discharge
Heart Failure re-hospitalization
Time Frame: 1 year post-discharge
1 year post-discharge
All-cause re-hospitalization
Time Frame: 30 days and 1 year post-discharge
30 days and 1 year post-discharge
All-cause and cardiovascular mortality
Time Frame: 30 days and 1 year post-discharge
30 days and 1 year post-discharge
Incident stroke/TIA or systemic thromboembolism
Time Frame: 30 days and 1 year post-discharge
30 days and 1 year post-discharge
Myocardial infarction
Time Frame: 30 days and 1 year post-discharge
30 days and 1 year post-discharge
Patient acceptance of device monitoring
Time Frame: 30 days post-discharge
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Population Health Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Heart and Stroke Foundation of Canada
Canadian Cardiovascular Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jorge A Wong, MD, MPH, Population Health Research Institute
  • Principal Investigator: Stuart Connolly, MD, Population Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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