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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Centre for Cardiovascular Innovation | UNKNOWN |
| NHS Greater Glasgow & Clyde | UNKNOWN |
| HeartLife Foundation |
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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
Heart failure describes a chronic condition where the heart muscle is no longer able to supply the body with enough oxygen and nutrients. This can lead to fatigue and poor quality of life. Often, people do not know they have heart failure until they end up in hospital. This study wants to improve the screening of heart failure and identify patients at risk for heart failure earlier. This will help determine if early-screening and treatment can help prevent further decline in these patients.
This is a randomized, un-blinded study comparing usual care to an intervention group receiving early heart failure testing. Pre-screening will be performed using extracted primary care electronic health records with the case finding algorithm based on the inclusion and exclusion criteria. An invitation letter will be send to prospective patients which include a registration telephone number and link to dedicated study website. The invitation for contact will adopt an "opt out" approach (ask the potential participant to contact the coordinating centre if they do not wish to be contacted).
Potential participants not opting out, or opting in, within 2 weeks of invitation mailing will be sent a patient information package along with follow up contact by research team.
Consented participants will be randomized either to usual care or interventions group and followed for six months. Intervention group will have NT-proBNP drawn and those with an elevated NT-proBNP (>125pg/mL) will have a study visit with assessments to include, physical examination, electrocardiogram and study AI echocardiogram.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Routine care arm | No Intervention | Participants will be remotely monitored for number of heart failure events |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT-proBNP | Diagnostic Test | blood sample to measure N-terminal prohormone of B-type natriuretic peptide at local laboratory |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of prescription for guideline recommended HF therapies in patients diagnosed with HFrEF | number of diagnosis of HF with reduced Ejection Fraction (HFrEF) within 6 months. Patients diagnosed with HFrEF receiving Guideline-directed medical therapy within 6 months | enrollment to six months |
| HF events in HFrEF |
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Inclusion Criteria:
Male or female > 40 years of age
Informed consent
At least two additional risk factors for Heart Failure (HF):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naomi Uchida, BSN | Contact | 16048754521 | naomi.uchida@ubc.ca | |
| Jennifer Petterson | Contact | 604-875-5104 | jenny.petterson@vch.ca |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| UNKNOWN |
| Canadian Heart Function Alliance | UNKNOWN |
| Montreal Heart Institute | OTHER |
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| AI echocardiogram | Diagnostic Test | Artificial intelligence driven transthoracic echocardiogram |
|
| electrocardiogram | Diagnostic Test | tracing of electrical cardiac activity of the heart |
|
| Cardiovascular physical examination | Other | basic physiological measurements to include height (cm), weight (kg) and hip circumference (cm) and blood pressure (mmHg) |
|
number of HF admissions |
| enrollment to six months |
| Serge LePage, MD | Centre Hospitalier Universite de Sherbrooke-Hopital Fleurimont | Principal Investigator |
| Montreal Heart Institute | Not yet recruiting | Montreal | Quebec | H1T 1C8 | Canada |
|
| University of Sherbrooke | Not yet recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
|
| D004568 | Electrodiagnosis |