Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure

NCT05859048 | Recruiting DMC

• 1 other identifier: MAPLE-CHF
• Study Type: interventional
• Target: 1,360
• Locations: 1 country
• Sites: 3

Brief 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) 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

Conditions

Heart Failure

Keywords

Heart failure screening; natriuretic peptides; artificial intelligence echocardiography

Outcome Measures

Primary Outcomes (4)

• 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.

  enrollment to six months

• Number of outpatient HF visits

  Number of outpatient visits for HF with initiation or intensification of oral HF therapy

  enrollment to six months

• Number of urgent HF visit

  Incidence of HF presentation in urgent care setting with administration of intravenous HF therapies

  enrollment to six months

• Number of HF hospitalizations

  Number of admission for HF

  enrollment to six months

Secondary Outcomes (2)

• incidence of prescription for guideline recommended HF therapies in patients diagnosed with HFrEF

  enrollment to six months

• HF events in HFrEF

  enrollment to six months

Study Arms (2)

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

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

Interventions

NT-proBNP DIAGNOSTIC_TEST

blood sample to measure N-terminal prohormone of B-type natriuretic peptide at local laboratory

Investigational arm guided by NT-proBNP result

AI echocardiogram DIAGNOSTIC_TEST

Artificial intelligence driven transthoracic echocardiogram

Investigational arm guided by NT-proBNP result

electrocardiogram DIAGNOSTIC_TEST

tracing of electrical cardiac activity of the heart

Investigational arm guided by NT-proBNP result

Cardiovascular physical examination OTHER

basic physiological measurements to include height (cm), weight (kg) and hip circumference (cm) and blood pressure (mmHg)

Investigational arm guided by NT-proBNP result

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
• 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.
• 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.

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 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.

Sponsors & Collaborators

• Cardiology Research UBC: lead
• AstraZeneca: collaborator
• Centre for Cardiovascular Innovation: collaborator
• NHS Greater Glasgow & Clyde: collaborator
• HeartLife Foundation: collaborator
• Canadian Heart Function Alliance: collaborator
• Montreal Heart Institute: collaborator

Study Sites (3)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

NOT YET RECRUITING

University of Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Nathaniel M Hawkins, MD

  Associate Professor of Medicine, UBC Division of Cardiology

  PRINCIPAL INVESTIGATOR

• Anique Ducharme, MD

  Professor of Medicine, Univeriste de Montreal, Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

• Serge LePage, MD

  Centre Hospitalier Universite de Sherbrooke-Hopital Fleurimont

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Uchida, BSN

CONTACT

16048754521; naomi.uchida@ubc.ca

Jennifer Petterson

CONTACT

604-875-5104; jenny.petterson@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 15, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

CA (3)