Multidisciplinary Screening for Heart Failure

(MAPLE-CHF Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Serge LePage, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Cardiology Research UBC

Disqualifiers: Heart failure, Renal replacement, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a computer program to identify potential heart failure patients from medical records, followed by blood tests and AI heart imaging. It targets patients at risk of heart failure to catch the condition early. The process involves scanning records, testing blood for a specific marker, and using AI for detailed heart images if needed.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment AI echocardiogram, Artificial Intelligence Echocardiogram, AI Echocardiogram, Electrocardiogram, ECG, 12-lead electrocardiogram, NT-proBNP, N-terminal pro-brain natriuretic peptide, N-terminal prohormone of B-type natriuretic peptide for heart failure?

Research shows that AI-enabled electrocardiograms (ECGs) can accurately predict levels of BNP and NT-proBNP, which are important markers for heart health, and may help monitor cardiovascular disease risk. Additionally, AI ECGs have been effective in detecting heart function issues, like left ventricular systolic dysfunction, which is related to heart failure. ^{1 2 3 4 5}

Is the AI-enabled electrocardiogram safe for use in humans?

The AI-enabled electrocardiogram (ECG) has been tested in various studies and is generally considered safe for use in humans. It has been used to accurately predict heart-related conditions and improve screening for heart dysfunction without reported safety concerns. ^{1 2 6 7 8}

How is the multidisciplinary screening for heart failure treatment different from other treatments?

This treatment is unique because it combines artificial intelligence with traditional heart tests like echocardiograms and electrocardiograms to improve the detection of heart problems. The AI-enhanced approach can identify heart issues earlier and more accurately, especially in non-cardiology settings, and when combined with natriuretic peptide testing, it offers a more comprehensive screening for heart failure. ^{2 9 10 11 12}

Research Team

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

Eligibility Criteria

This trial is for adults over 40 with risk factors like coronary artery disease, diabetes, atrial fibrillation, stroke history, regular diuretic use, COPD, peripheral artery disease or chronic kidney disease. It's not for those who can't consent, already have heart failure diagnosis or are on renal replacement therapy.

Inclusion Criteria

I have COPD confirmed by tests, a doctor, or I'm on COPD treatment.

I have been using water pills regularly for over a month in the past year.

I have two or more risk factors for heart failure.

Exclusion Criteria

I am on dialysis.

I am able to understand and agree to the study's procedures and risks.

I have been diagnosed with heart failure before.

Trial Timeline

Pre-screening

Pre-screening using extracted primary care electronic health records with a case finding algorithm

2 weeks

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm undergo NT-proBNP testing, and if elevated, receive an AI echocardiogram and ECG

6 months

Study visit within 28 days of NT-proBNP result for elevated cases

Routine Care

Participants in the routine care arm are monitored for heart failure events

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• AI echocardiogram (Diagnostic Test)
• Electrocardiogram (Diagnostic Test)
• NT-proBNP (Diagnostic Test)

Trial Overview The study tests if a special algorithm to find heart failure signs in electronic health records plus additional screening (NT-proBNP blood test and AI echocardiogram) can detect heart failure earlier compared to usual care methods.

Participant Groups

Group I: Investigational arm guided by NT-proBNP result Active Control 4 Interventions

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

Group II: Routine care arm Active Control 1 Intervention

Participants will be remotely monitored for number of heart failure events

AI echocardiogram is already approved in Canada for the following indications:

Approved in Canada as AI Echocardiogram for:

• Heart Failure Diagnosis
• Cardiac Function Assessment

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Vancouver General Hospital Vancouver, Canada

Montreal Heart Institute Montréal, Canada

University of Sherbrooke Sherbrooke, Canada

Who Is Running the Clinical Trial?

Cardiology Research UBC

Lead Sponsor

Trials

16

Patients Recruited

7,100+

Centre for Cardiovascular Innovation

Collaborator

Trials

1

Patients Recruited

1,400+

NHS Greater Glasgow & Clyde

Collaborator

Trials

1

Patients Recruited

1,400+

Montreal Heart Institute

Collaborator

Trials

125

Patients Recruited

85,400+

AstraZeneca

Industry Sponsor

Trials

4491

Patients Recruited

290,540,000+

Canadian Heart Function Alliance

Collaborator

Trials

2

Patients Recruited

1,400+

HeartLife Foundation

Collaborator

Trials

1

Patients Recruited

1,400+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial Intelligence-Enabled Electrocardiography Detects B-Type Natriuretic Peptide and N-Terminal Pro-Brain Natriuretic Peptide. Liu, PY., Lin, C., Lin, CS., et al.[2023]

Artificial intelligence-enabled electrocardiography (AIeECG) shows high diagnostic accuracy for detecting left ventricular systolic dysfunction (LVSD), with a median area under the curve (AUC) of 0.90, sensitivity of 83.3%, and specificity of 87% across various populations.

AIeECG can be particularly beneficial in non-cardiology settings and when used alongside natriuretic peptide testing, but further prospective randomized trials are needed to assess its impact on treatment outcomes and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial intelligence enabled ECG screening for left ventricular systolic dysfunction: a systematic review. Bjerkén, LV., Rønborg, SN., Jensen, MT., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

N-terminal pro-B-type natriuretic peptide-guided therapy in patients hospitalized for acute heart failure. Carubelli, V., Lombardi, C., Lazzarini, V., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NT-proBNP Qualifies as a Surrogate for Clinical End Points in Heart Failure. Schmitt, W., Rühs, H., Burghaus, R., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of atrial fibrillation on plasma NT-proBNP in chronic heart failure. Corell, P., Gustafsson, F., Kistorp, C., et al.[2007]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blinded, randomized trial of sonographer versus AI cardiac function assessment. He, B., Kwan, AC., Cho, JH., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for cardiac contractile dysfunction using an artificial intelligence-enabled electrocardiogram. Attia, ZI., Kapa, S., Lopez-Jimenez, F., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of external validation and subgroup analysis of artificial intelligence in the detection of low ejection fraction from electrocardiograms. Yagi, R., Goto, S., Katsumata, Y., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Analytical Performances and Comparison of 3 NT-proBNP Assays for Diagnosing Heart Failure. Cho, J., Lee, JH., Lee, SG.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

B-type natriuretic peptides and echocardiographic measures of cardiac structure and function. Troughton, RW., Richards, AM.[2016]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma cardiac natriuretic peptide determination as a screening test for the detection of patients with mild left ventricular impairment. Omland, T., Aakvaag, A., Vik-Mo, H.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Natriuretic peptides as cardiac markers in clinical practice]. Veien, KT., Jensen, JK., Hildebrandt, P., et al.[2015]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Artificial Intelligence-Enabled Electrocardiography Detects B-Type Natriuretic Peptide and N-Terminal Pro-Brain Natriuretic Peptide. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Artificial intelligence enabled ECG screening for left ventricular systolic dysfunction: a systematic review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

N-terminal pro-B-type natriuretic peptide-guided therapy in patients hospitalized for acute heart failure. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

NT-proBNP Qualifies as a Surrogate for Clinical End Points in Heart Failure. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of atrial fibrillation on plasma NT-proBNP in chronic heart failure. [2007]

6. England pubmed.ncbi.nlm.nih.gov

Blinded, randomized trial of sonographer versus AI cardiac function assessment. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Screening for cardiac contractile dysfunction using an artificial intelligence-enabled electrocardiogram. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Importance of external validation and subgroup analysis of artificial intelligence in the detection of low ejection fraction from electrocardiograms. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Analytical Performances and Comparison of 3 NT-proBNP Assays for Diagnosing Heart Failure. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

B-type natriuretic peptides and echocardiographic measures of cardiac structure and function. [2016]

11. England pubmed.ncbi.nlm.nih.gov

Plasma cardiac natriuretic peptide determination as a screening test for the detection of patients with mild left ventricular impairment. [2019]

12. Denmark pubmed.ncbi.nlm.nih.gov

[Natriuretic peptides as cardiac markers in clinical practice]. [2015]