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

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Us2.ai (AI-enabled report) handheld echocardiogram
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of British Columbia
  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

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

CONTROL routine care arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Primary endpoint
A diagnosis of heart failure within 6 months from randomisation. 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.

Secondary Outcome Measures

Secondary endpoints
Diagnosis of HFrEF within 6 months. • Patients diagnosed with HFrEF receiving GDMT within 6 months. Guideline-directed medical therapy is defined as simultaneously receiving the 4 drugs with a Class I guideline recommendation for HFrEF (unless not tolerated or contraindicated): Angiotensin receptor neprilysin inhibitor, beta blockers, mineralocorticoid receptor antagonists, sodium-glucose cotransporter-2 inhibitors.

Full Information

First Posted
May 8, 2023
Last Updated
May 8, 2023
Sponsor
Montreal Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05860608
Brief Title
Multidisciplinary Approach for High-risk Patients Leading to Early Diagnosis of Canadians With Heart Failure
Acronym
MAPLE-CHF
Official Title
Multidisciplinary Approach for High-risk Patients Leading to Early Diagnosis of Canadians With Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1358 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACTIVE investigational arm (NT-proBNP + AI-ECHO)
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL routine care arm
Arm Type
Other
Arm Description
Patients randomized to usual care will undergo standard clinical follow-up, with NT-proBNP and conventional echocardiography prescribed only as per usual practice.
Intervention Type
Device
Intervention Name(s)
Us2.ai (AI-enabled report) handheld echocardiogram
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary endpoint
Description
A diagnosis of heart failure within 6 months from randomisation. 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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary endpoints
Description
Diagnosis of HFrEF within 6 months. • Patients diagnosed with HFrEF receiving GDMT within 6 months. Guideline-directed medical therapy is defined as simultaneously receiving the 4 drugs with a Class I guideline recommendation for HFrEF (unless not tolerated or contraindicated): Angiotensin receptor neprilysin inhibitor, beta blockers, mineralocorticoid receptor antagonists, sodium-glucose cotransporter-2 inhibitors.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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