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

NCT05860608 | Withdrawn DMC

• 1 other identifier: 2023-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  In both arms the diagnosis of HF will be determined by the occurrence of one or more of the following (defined in Appendix 4): * An outpatient diagnosis of heart failure according to the ESC 2021 Heart Failure Guidelines. * Outpatient heart failure visit. * Urgent heart failure visit. * Heart failure hospitalisation.

  6 months

Secondary Outcomes (1)

• Secondary endpoints

  6 months

Study Arms (2)

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

EXPERIMENTAL

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.

Device: Us2.ai (AI-enabled report) handheld echocardiogram

CONTROL routine care arm

OTHER

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

Device: Us2.ai (AI-enabled report) handheld echocardiogram

Interventions

Us2.ai (AI-enabled report) handheld echocardiogram 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.

ACTIVE investigational arm (NT-proBNP + AI-ECHO); CONTROL routine care arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (2)

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc. Professor of Medicine, Université de Montréal. Department of Medicine, Montreal Heart Institute

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 16, 2023
• Study Start: November 20, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)