Multidisciplinary Approach for High-risk Patients Leading to Early Diagnosis of Canadians With Heart Failure

NCT ID: NCT05860608

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-20
• Study Completion Date: 2024-11-20

Brief Summary

In the MAPLE-CHF trial, patients will be screened for HF risk factors using electronic medical records of participating family physicians to identify patients with potentially undiagnosed HF. Participants will then undergo a diagnostic evaluation using a blood sample for a hormone specific to the heart, the natriuretic peptide or NT-proBNP; if elevated, a portable cardiac ultrasound (ECHO) with artificial intelligence (AI) interpretation will be done; both NT-proBNP and ECHO are required for diagnosis in patients with signs and symptoms suggestive of HF. This screening ECHO coupled with AI reading from Us2.ai provides a fast, reliable, and inexpensive report, which is particularly important in our context, where waiting lists for such examinations can reach up to one year.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ACTIVE investigational arm (NT-proBNP + AI-ECHO)

NT-proBNP will be performed in all individuals randomized to the ACTIVE arm at the same visit as informed consent; those with elevated NT-proBNP (≥125pg/ml) will undergo an Us2.ai (AI-enabled report) handheld echocardiogram within one month of NT-proBNP testing. A standard echocardiographic study will be performed if the AI-echo is non-diagnostic.

Group Type: EXPERIMENTAL

Us2.ai (AI-enabled report) handheld echocardiogram

Intervention Type: DEVICE

NT-proBNP will be performed in all individuals randomized to the ACTIVE arm at the same visit as informed consent, and those with elevated NT-proBNP (≥125pg/ml) will be invited to attend a visit for an Us2.ai (AI-enabled) echocardiogram which will be controlled with a standard echocardiographic study if the AI-echo is non-diagnostic.

CONTROL routine care arm

Patients randomized to usual care will undergo standard clinical follow-up, with NT-proBNP and conventional echocardiography prescribed only as per usual practice.

Group Type: OTHER

Us2.ai (AI-enabled report) handheld echocardiogram

Intervention Type: DEVICE

NT-proBNP will be performed in all individuals randomized to the ACTIVE arm at the same visit as informed consent, and those with elevated NT-proBNP (≥125pg/ml) will be invited to attend a visit for an Us2.ai (AI-enabled) echocardiogram which will be controlled with a standard echocardiographic study if the AI-echo is non-diagnostic.

Interventions

Us2.ai (AI-enabled report) handheld echocardiogram

NT-proBNP will be performed in all individuals randomized to the ACTIVE arm at the same visit as informed consent, and those with elevated NT-proBNP (≥125pg/ml) will be invited to attend a visit for an Us2.ai (AI-enabled) echocardiogram which will be controlled with a standard echocardiographic study if the AI-echo is non-diagnostic.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Male or female ≥40 years of age informed consent and at least two additional risk factors for 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 type 2, persistent or permanent atrial fibrillation, previous ischemic or embolic stroke peripheral arterial disease (previous surgical or percutaneous revascularization or documented stenosis >50% of major peripheral arterial vessel), chronic kidney disease (estimated glomerular filtration rate <60mL/min/1.73m2 or eGFR 60-90mL/min/1.73m2 and UACR >300mg/g), regular loop diuretic use for >30 days within 12 months COPD (evidenced by one of the following: PFTs showing airway obstruction diagnosis by respiratory physician CT scan reporting presence of emphysema, or treatment with national guideline COPD therapy).

Exclusion Criteria

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 investigators' opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montreal Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Anique Ducharme

MD, MSc. Professor of Medicine, Université de Montréal. Department of Medicine, Montreal Heart Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2023-001

Identifier Type: -

Identifier Source: org_study_id