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

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
NT-proBNP
AI echocardiogram
electrocardiogram
Cardiovascular physical examination
Sponsored by
Cardiology Research UBC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Heart Failure focused on measuring Heart failure screening, natriuretic peptides, artificial intelligence echocardiography

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 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. 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 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.

Sites / Locations

  • Vancouver General Hospital
  • Montreal Heart Institute
  • University of Sherbrooke

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Investigational arm guided by NT-proBNP result

Routine care arm

Arm Description

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

Participants will be remotely monitored for number of heart failure events

Outcomes

Primary Outcome Measures

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.
Number of outpatient HF visits
Number of outpatient visits for HF with initiation or intensification of oral HF therapy
Number of urgent HF visit
Incidence of HF presentation in urgent care setting with administration of intravenous HF therapies
Number of HF hospitalizations
Number of admission for HF

Secondary Outcome Measures

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
HF events in HFrEF
number of HF admissions

Full Information

First Posted
May 1, 2023
Last Updated
June 8, 2023
Sponsor
Cardiology Research UBC
Collaborators
AstraZeneca, Centre for Cardiovascular Innovation, NHS Greater Glasgow & Clyde, HeartLife Foundation, Canadian Heart Function Alliance, Montreal Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05859048
Brief Title
Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure
Acronym
MAPLE-CHF
Official Title
Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiology Research UBC
Collaborators
AstraZeneca, Centre for Cardiovascular Innovation, NHS Greater Glasgow & Clyde, HeartLife Foundation, Canadian Heart Function Alliance, Montreal Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure screening, natriuretic peptides, artificial intelligence echocardiography

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational arm guided by NT-proBNP result
Arm Type
Active Comparator
Arm Description
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
Arm Title
Routine care arm
Arm Type
No Intervention
Arm Description
Participants will be remotely monitored for number of heart failure events
Intervention Type
Diagnostic Test
Intervention Name(s)
NT-proBNP
Intervention Description
blood sample to measure N-terminal prohormone of B-type natriuretic peptide at local laboratory
Intervention Type
Diagnostic Test
Intervention Name(s)
AI echocardiogram
Intervention Description
Artificial intelligence driven transthoracic echocardiogram
Intervention Type
Diagnostic Test
Intervention Name(s)
electrocardiogram
Intervention Description
tracing of electrical cardiac activity of the heart
Intervention Type
Other
Intervention Name(s)
Cardiovascular physical examination
Intervention Description
basic physiological measurements to include height (cm), weight (kg) and hip circumference (cm) and blood pressure (mmHg)
Primary Outcome Measure Information:
Title
Number of participants diagnosed with heart failure (HF) according to the European Society of Cardiology 2021 HF guidelines
Description
Incidence of HF diagnosis in outpatient settings Urgent heart failure visit. Heart failure hospitalization.
Time Frame
enrollment to six months
Title
Number of outpatient HF visits
Description
Number of outpatient visits for HF with initiation or intensification of oral HF therapy
Time Frame
enrollment to six months
Title
Number of urgent HF visit
Description
Incidence of HF presentation in urgent care setting with administration of intravenous HF therapies
Time Frame
enrollment to six months
Title
Number of HF hospitalizations
Description
Number of admission for HF
Time Frame
enrollment to six months
Secondary Outcome Measure Information:
Title
incidence of prescription for guideline recommended HF therapies in patients diagnosed with HFrEF
Description
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
Time Frame
enrollment to six months
Title
HF events in HFrEF
Description
number of HF admissions
Time Frame
enrollment to six 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 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. 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naomi Uchida, BSN
Phone
16048754521
Email
naomi.uchida@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Petterson
Phone
604-875-5104
Email
jenny.petterson@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel M Hawkins, MD
Organizational Affiliation
Associate Professor of Medicine, UBC Division of Cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anique Ducharme, MD
Organizational Affiliation
Professor of Medicine, Univeriste de Montreal, Montreal Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Serge LePage, MD
Organizational Affiliation
Centre Hospitalier Universite de Sherbrooke-Hopital Fleurimont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathaniel Hawkins, MD
Phone
604-875-5264
Email
nat.hawkins@ubc.ca
First Name & Middle Initial & Last Name & Degree
Sean Virani, MD
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anique Ducharme, MD
Phone
514-376-3330
Ext
3927
Email
anique.ducharme@umontreal.ca
Facility Name
University of Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge LePage, MD
Phone
819-349-1788
Email
serge.lepage@usherbrooke.ca

12. IPD Sharing Statement

Learn more about this trial

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

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