Heart FailurePROTECT-HFNCT03541616
Prevalence of Subclinical Atrial Fibrillation in Heart Failure Patients and Its Relationship With Hospital Readmission
An observational study of Heart Failure and Atrial Fibrillation, run by Population Health Research Institute at 5 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Atrial Fibrillation
- What is being tested?
- ECG Patch, pocket ECG monitor
- Type of treatment
- Medical device
- How many people
- 242 participants
- Where
- 5 sitesCanada
- Study dates
- 24 Mar 2018to 27 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a history of HF who are admitted to hospital with acutely decompensated HF and have no prior history of AF.
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Hamilton General Hospital
Hamilton, Ontario
Juravinski Hospital
Hamilton, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
St. Mary's Hospital
Kitchener, Ontario, N2M1B2
St. Catherines General Hospital
St. Catharines, Ontario, L2S0A9
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Heart Failure, Atrial Fibrillation
- Being tested
- ECG Patch, pocket ECG monitor
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG Patch, pocket ECG monitorDevice
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 .
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Patients | Not described Receives: Device: ECG Patch, pocket ECG monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subclinical atrial fibrillation ≥30 minutes in duration
Measured: 30 days post-discharge
Secondary outcomes (1)
Heart failure re-hospitalization
Measured: 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start24 Mar 2018
- Primary completion31 Jan 2022
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Canadian Cardiovascular Society
- Responsible party
- Sponsor
- Investigators
- Jorge A Wong, MD, MPH, Principal investigator, Population Health Research InstituteStuart Connolly, MD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541616
- Sponsor's protocol ID
- PROTECT-HF
- Acronym
- PROTECT-HF
- Status last verified
- Mar 2023
- First submitted
- 17 May 2018
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong JA, Mistry P, Patel A, Jolly U, Benz A, Yuan F, Pinilla-Echeverri N, Almidani G, Latendresse N, Grinvalds A, Vowotor E, Chen J, Grindal A, Rajkumar S, Almhri A, Bangdiwala S, McIntyre WF, Conen D, Devereaux PJ, Healey JS, Connolly SJ. Prevalence and Clinical Outcomes of Subclinical Atrial Fibrillation After Heart Failure Hospitalization. CJC Open. 2026 Jun 1;8(9):1151-1157. doi: 10.1016/j.cjco.2026.05.012. eCollection 2026 Sep.
PubMed 42756445
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Subclinical Atrial Fibrillation in High Risk Heart Failure Patients and Its Temporal Relationship With Hospital Readmission for Heart Failure
- ClinicalTrials.gov ID
- NCT03541616
- Acronym / sponsor ID
- PROTECT-HF / PROTECT-HF
- Conditions
- Heart Failure, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Canadian Cardiovascular Society
- Study start
- 24 Mar 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Patients | – | Device: ECG Patch, pocket ECG monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a history of HF who are admitted to hospital with acutely decompensated HF and have no prior history of AF.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG Patch, pocket ECG monitorTwo 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 . | Device | Enrolled Patients |
Primary outcome
Subclinical atrial fibrillation ≥30 minutes in duration
Time frame: 30 days post-discharge
1 secondary outcome
Heart failure re-hospitalization
Time frame: 30 days post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Derived from this study: PubMed 42756445Wong JA, Mistry P, Patel A, Jolly U, Benz A, Yuan F, Pinilla-Echeverri N, Almidani G, Latendresse N, Grinvalds A, Vowotor E, Chen J, Grindal A, Rajkumar S, Almhri A, Bangdiwala S, McIntyre WF, Conen D, Devereaux PJ, Healey JS, Connolly SJ. Prevalence and Clinical Outcomes of Subclinical Atrial Fibrillation After Heart Failure Hospitalization. CJC Open. 2026 Jun 1;8(9):1151-1157. doi: 10.1016/j.cjco.2026.05.012. eCollection 2026 Sep.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge A Wong, MD, MPH principal investigator
Population Health Research Institute
Stuart Connolly, MD principal investigator
Population Health Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Atrial Fibrillation, run by Population Health Research Institute at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subclinical atrial fibrillation ≥30 minutes in duration (time frame: 30 days post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03541616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.