Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05859048
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-05-01
Brief Title:
Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure
Sponsor:
Cardiology Research UBC
Organization:
Cardiology Research UBC
Study Overview
Official Title:
Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAPLE-CHF
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 questions 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 125pgml 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
The main questions 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 125pgml 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 125pgmL will have a study visit with assessments to include physical examination electrocardiogram and study AI echocardiogram
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 125pgmL will have a study visit with assessments to include physical examination electrocardiogram and study AI echocardiogram
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None