Multidisciplinary Approach for High-risk Patients Leading to Early Diagnosis of Canadians With Heart Failure (MAPLE-CHF)
Multidisciplinary Approach for High-risk Patients Leading to Early Diagnosis of Canadians With Heart Failure.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- University of British Columbia
-
-
Quebec
-
Montréal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary endpoint
Time Frame: 6 months
|
In both arms the diagnosis of HF will be determined by the occurrence of one or more of the following (defined in Appendix 4):
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary endpoints
Time Frame: 6 months
|
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. |
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-001 (Other Identifier: University of Missouri)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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