Heart FailureMAPLE-CHFNCT05859048
Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure
A study testing NT-proBNP, AI echocardiogram and electrocardiogram in people with Heart Failure, run by Cardiology Research UBC at 3 sites in Canada.
Trial summary
The goal of this study is improve the screening of heart failure and identify patients early who are at risk of heart failure. The main question[s] it aims to answer are: will an electronic health records (EHR) case finding algorithm for heart failure, followed by N-Terminal pro-brain natriuretic peptide (NT-proBNP)… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- NT-proBNP, AI echocardiogram and electrocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,360 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Mar 2024to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female > 40 years of age
- Informed consent
- At least two additional risk factors for Heart Failure (HF):
- Coronary artery disease (either a previous documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis or an epicardial coronary artery (50% left main stem or >70% left anterior descending, circumflex or right coronary artery)).
- Diabetes type 1 or 2.
- Persistent or permanent atrial fibrillation.
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- Previous ischemic or embolic stroke.
- Peripheral artery disease (previous surgical or percutaneous revascularization or documented stenosis >50% of major peripheral arterial vessel.
- Chronic kidney disease (defined as an estimated glomerular filtration rate (eGFR)<60 milliliters per minute (mL/min)/1.73m2 or eGFR 60-90 mL/min/1.73m2 and urine albumin-creatinine ration (UACR) >300mg/g).
- Regular loop diuretic use for >30 days within 12 months prior to consent.
- Chronic obstructive pulmonary disease (COPD) evidenced by one of the following: Pulmonary Function Test (PFT) showing airway obstruction, diagnosis of respiratory physician, CT scan reporting presence of emphysema, or treatment with national guidance advocated COPD therapy.
Who cannot join
- Inability to give informed consent (e.g. due to significant cognitive impairment).
- Previous diagnosis of heart failure. This is any diagnosis of heart failure with any ejection fraction of any cause.
- Renal replacement therapy.
- Anyone who, in the investigator's opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Not yet recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Anique Ducharme, MD, 514-376-3330 ext. 3927, anique.ducharme@umontreal.ca
- Not yet recruiting
University of Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Serge LePage, MD, 819-349-1788, serge.lepage@usherbrooke.ca
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Nathaniel Hawkins, MD, 604-875-5264, nat.hawkins@ubc.ca
Sean Virani, MD
About this study
Official title: Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians
The goal of this study is improve the screening of heart failure and identify patients early who are at risk of heart failure.
The main question[s] it aims to answer are:
Read more
- will an electronic health records (EHR) case finding algorithm for heart failure, followed by N-Terminal pro-brain natriuretic peptide (NT-proBNP) screening and artificial intelligence (AI) echocardiogram compared to usual care identify patients at risk for heart failure earlier than standard of care?
Participants will be enrolled and randomized to either standard of care (SOC) or intervention arm:
SOC arm: electronic health records will be reviewed over six months for assessments performed to identify heart failure.
Intervention arm: blood sample for N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) at local laboratory . For elevated NT-proBNP results (>125pg/ml) an artificial intelligence (AI) echocardiogram and 12 lead electrocardiogram (ECG) will be performed at study site (within 28 days of NT-proBNP result). EHR will be reviewed at six months
Read the detailed description
Heart failure describes a chronic condition where the heart muscle is no longer able to supply the body with enough oxygen and nutrients. This can lead to fatigue and poor quality of life. Often, people do not know they have heart failure until they end up in hospital. This study wants to improve the screening of heart failure and identify patients at risk for heart failure earlier. This will help determine if early-screening and treatment can help prevent further decline in these patients.
This is a randomized, un-blinded study comparing usual care to an intervention group receiving early heart failure testing. Pre-screening will be performed using extracted primary care electronic health records with the case finding algorithm based on the inclusion and exclusion criteria. An invitation letter will be send to prospective patients which include a registration telephone number and link to dedicated study website. The invitation for contact will adopt an "opt out" approach (ask the potential participant to contact the coordinating centre if they do not wish to be contacted).
Potential participants not opting out, or opting in, within 2 weeks of invitation mailing will be sent a patient information package along with follow up contact by research team.
Consented participants will be randomized either to usual care or interventions group and followed for six months. Intervention group will have NT-proBNP drawn and those with an elevated NT-proBNP (>125pg/mL) will have a study visit with assessments to include, physical examination, electrocardiogram and study AI echocardiogram.
- Conditions
- Heart Failure
- Being tested
- NT-proBNP, AI echocardiogram, electrocardiogram, Cardiovascular physical examination
- Keywords
- Heart failure screening, natriuretic peptides, artificial intelligence echocardiography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-proBNPDiagnostic test
blood sample to measure N-terminal prohormone of B-type natriuretic peptide at local laboratory
AI echocardiogramDiagnostic test
Artificial intelligence driven transthoracic echocardiogram
electrocardiogramDiagnostic test
tracing of electrical cardiac activity of the heart
Cardiovascular physical examinationOther
basic physiological measurements to include height (cm), weight (kg) and hip circumference (cm) and blood pressure (mmHg)
| Study group | Role | What they receive |
|---|---|---|
| Investigational arm guided by NT-proBNP result | Active comparator | NT-proBNP drawn and if level elevated (>125 pg/ml) a study visit with artificial intelligence (AI) echocardiogram, electrocardiogram (ECG), and heart failure (HF) focused examination conducted Receives: Diagnostic Test: NT-proBNP; Diagnostic Test: AI echocardiogram; Diagnostic Test: electrocardiogram; Other: Cardiovascular physical examination |
| Routine care arm | No intervention | Participants will be remotely monitored for number of heart failure events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants diagnosed with heart failure (HF) according to the European Society of Cardiology 2021 HF guidelines
Incidence of HF diagnosis in outpatient settings Urgent heart failure visit. Heart failure hospitalization.
Measured: enrollment to six months
Number of outpatient HF visits
Number of outpatient visits for HF with initiation or intensification of oral HF therapy
Measured: enrollment to six months
Number of urgent HF visit
Incidence of HF presentation in urgent care setting with administration of intravenous HF therapies
Measured: enrollment to six months
Number of HF hospitalizations
Number of admission for HF
Measured: enrollment to six months
Secondary outcomes (2)
incidence of prescription for guideline recommended HF therapies in patients diagnosed with HFrEF
number of diagnosis of HF with reduced Ejection Fraction (HFrEF) within 6 months.
Patients diagnosed with HFrEF receiving Guideline-directed medical therapy within 6 months
Measured: enrollment to six months
HF events in HFrEF
number of HF admissions
Measured: enrollment to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Mar 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiology Research UBC
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, NHS Greater Glasgow and Clyde, Montreal Heart Institute, The Centre for Cardiovascular Innovation - Centre d'Innovation Cardiovasculaire (CCI-CIC), Canadian Heart Function Alliance, HeartLife Foundation
- Responsible party
- Principal investigator, Nathaniel Hawkins, Cardiology Research UBC
- Investigators
- Nathaniel M Hawkins, MD, Principal investigator, Associate Professor of Medicine, UBC Division of CardiologyAnique Ducharme, MD, Principal investigator, Professor of Medicine, Univeriste de Montreal, Montreal Heart InstituteSerge LePage, MD, Principal investigator, Centre Hospitalier Universite de Sherbrooke-Hopital Fleurimont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859048
- Sponsor's protocol ID
- MAPLE-CHF
- Acronym
- MAPLE-CHF
- Status last verified
- Nov 2026
- First submitted
- 1 May 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians
- ClinicalTrials.gov ID
- NCT05859048
- Acronym / sponsor ID
- MAPLE-CHF / MAPLE-CHF
- Conditions
- Heart Failure
- Keywords
- Heart failure screening, natriuretic peptides, artificial intelligence echocardiography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,360 participants (estimated)
- Lead sponsor
- Cardiology Research UBCUniversity, hospital or other
- Collaborators
- AstraZeneca, NHS Greater Glasgow and Clyde, Montreal Heart Institute, The Centre for Cardiovascular Innovation - Centre d'Innovation Cardiovasculaire (CCI-CIC), Canadian Heart Function Alliance, HeartLife Foundation
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 15 May 2023 (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.
The goal of this study is improve the screening of heart failure and identify patients early who are at risk of heart failure.
The main question[s] it aims to answer are:
- will an electronic health records (EHR) case finding algorithm for heart failure, followed by N-Terminal pro-brain natriuretic peptide (NT-proBNP) screening and artificial intelligence (AI) echocardiogram compared to usual care identify patients at risk for heart failure earlier than standard of care?
Participants will be enrolled and randomized to either standard of care (SOC) or intervention arm:
SOC arm: electronic health records will be reviewed over six months for assessments performed to identify heart failure.
Intervention arm: blood sample for N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) at local laboratory . For elevated NT-proBNP results (>125pg/ml) an artificial intelligence (AI) echocardiogram and 12 lead electrocardiogram (ECG) will be performed at study site (within 28 days of NT-proBNP result). EHR will be reviewed at six months
Detailed description
Heart failure describes a chronic condition where the heart muscle is no longer able to supply the body with enough oxygen and nutrients. This can lead to fatigue and poor quality of life. Often, people do not know they have heart failure until they end up in hospital. This study wants to improve the screening of heart failure and identify patients at risk for heart failure earlier. This will help determine if early-screening and treatment can help prevent further decline in these patients.
This is a randomized, un-blinded study comparing usual care to an intervention group receiving early heart failure testing. Pre-screening will be performed using extracted primary care electronic health records with the case finding algorithm based on the inclusion and exclusion criteria. An invitation letter will be send to prospective patients which include a registration telephone number and link to dedicated study website. The invitation for contact will adopt an "opt out" approach (ask the potential participant to contact the coordinating centre if they do not wish to be contacted).
Potential participants not opting out, or opting in, within 2 weeks of invitation mailing will be sent a patient information package along with follow up contact by research team.
Consented participants will be randomized either to usual care or interventions group and followed for six months. Intervention group will have NT-proBNP drawn and those with an elevated NT-proBNP (>125pg/mL) will have a study visit with assessments to include, physical examination, electrocardiogram and study AI echocardiogram.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational arm guided by NT-proBNP result | Active comparator | Diagnostic Test: NT-proBNP, Diagnostic Test: AI echocardiogram, Diagnostic Test: electrocardiogram, Other: Cardiovascular physical examinationNT-proBNP drawn and if level elevated (>125 pg/ml) a study visit with artificial intelligence (AI) echocardiogram, electrocardiogram (ECG), and heart failure (HF) focused examination conducted |
| Routine care arm | No intervention | –Participants will be remotely monitored for number of heart failure events |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female > 40 years of age
- Informed consent
- At least two additional risk factors for Heart Failure (HF):
Key exclusion criteria (4 listed)
- Inability to give informed consent (e.g. due to significant cognitive impairment).
- Previous diagnosis of heart failure. This is any diagnosis of heart failure with any ejection fraction of any cause.
- Renal replacement therapy.
- Anyone who, in the investigator's opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period.
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 |
|---|---|---|
| NT-proBNPblood sample to measure N-terminal prohormone of B-type natriuretic peptide at local laboratory | Diagnostic test | Investigational arm guided by NT-proBNP result |
| AI echocardiogramArtificial intelligence driven transthoracic echocardiogram | Diagnostic test | Investigational arm guided by NT-proBNP result |
| electrocardiogramtracing of electrical cardiac activity of the heart | Diagnostic test | Investigational arm guided by NT-proBNP result |
| Cardiovascular physical examinationbasic physiological measurements to include height (cm), weight (kg) and hip circumference (cm) and blood pressure (mmHg) | Other | Investigational arm guided by NT-proBNP result |
Primary outcome
Number of participants diagnosed with heart failure (HF) according to the European Society of Cardiology 2021 HF guidelines
Time frame: enrollment to six months
Incidence of HF diagnosis in outpatient settings Urgent heart failure visit. Heart failure hospitalization.
Number of outpatient HF visits
Time frame: enrollment to six months
Number of outpatient visits for HF with initiation or intensification of oral HF therapy
Number of urgent HF visit
Time frame: enrollment to six months
Incidence of HF presentation in urgent care setting with administration of intravenous HF therapies
Number of HF hospitalizations
Time frame: enrollment to six months
Number of admission for HF
2 secondary outcomes
incidence of prescription for guideline recommended HF therapies in patients diagnosed with HFrEF
Time frame: enrollment to six months
HF events in HFrEF
Time frame: enrollment to six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
Nathaniel M Hawkins, MD principal investigator
Associate Professor of Medicine, UBC Division of Cardiology
Anique Ducharme, MD principal investigator
Professor of Medicine, Univeriste de Montreal, Montreal Heart Institute
Serge LePage, MD principal investigator
Centre Hospitalier Universite de Sherbrooke-Hopital Fleurimont
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NT-proBNP, AI echocardiogram and electrocardiogram in people with Heart Failure, run by Cardiology Research UBC at 3 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 11 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naomi Uchida, BSN (16048754521, naomi.uchida@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants diagnosed with heart failure (HF) according to the European Society of Cardiology 2021 HF guidelines (time frame: enrollment to six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.