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Completed

NCT Number: NCT03541616

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

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.

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

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About this study

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:

  • 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.
  • To examine the temporal association between subclinical AF ≥30 minutes in duration and 30-day hospital readmission for HF.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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).

Treatment and study plan

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 .

Primary outcomes

  1. Subclinical atrial fibrillation ≥30 minutes in duration

    Time frame: 30 days post-discharge

Secondary outcomes

  1. Heart failure re-hospitalization

    Time frame: 30 days post-discharge

Other outcomes

  1. Subclinical atrial fibrillation >6 minutes in duration

    Time frame: 30 days post-discharge

  2. Clinical atrial fibrillation

    Time frame: 30 days post-discharge

  3. Heart Failure re-hospitalization

    Time frame: 1 year post-discharge

  4. All-cause re-hospitalization

    Time frame: 30 days and 1 year post-discharge

  5. All-cause and cardiovascular mortality

    Time frame: 30 days and 1 year post-discharge

  6. Incident stroke/TIA or systemic thromboembolism

    Time frame: 30 days and 1 year post-discharge

  7. Myocardial infarction

    Time frame: 30 days and 1 year post-discharge

  8. 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.

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

  • Canadian Cardiovascular Society
  • Heart and Stroke Foundation of Canada

Registry information

Official study title

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

Acronym: PROTECT-HF

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
May 30, 2018
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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