Clinical trial NCT05859048: Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure
Official title: Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure screening
natriuretic peptides
artificial intelligence echocardiography
Lead sponsor: Cardiology Research UBC
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Centre for Cardiovascular Innovation
name: NHS Greater Glasgow & Clyde
name: HeartLife Foundation
name: Canadian Heart Function Alliance
name: Montreal Heart Institute
First posted: 2023-05-15
Enrollment: 1360
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Number of participants diagnosed with heart failure (HF) according to the European Society of Cardiology 2021 HF guidelines
timeFrame: enrollment to six months
measure: Number of outpatient HF visits
timeFrame: enrollment to six months
measure: Number of urgent HF visit
timeFrame: enrollment to six months
measure: Number of HF hospitalizations
timeFrame: enrollment to six months
Secondary outcomes:
measure: incidence of prescription for guideline recommended HF therapies in patients diagnosed with HFrEF
timeFrame: enrollment to six months
measure: HF events in HFrEF
timeFrame: enrollment to six months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Sherbrooke
country: Canada
facility: University of Sherbrooke
state: Quebec
Study officials:
affiliation: Associate Professor of Medicine, UBC Division of Cardiology
name: Nathaniel M Hawkins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Medicine, Univeriste de Montreal, Montreal Heart Institute
name: Anique Ducharme, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universite de Sherbrooke-Hopital Fleurimont
name: Serge LePage, MD
role: PRINCIPAL_INVESTIGATOR
References: