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

Heart Failure Clinical Trial

— MAPLE-CHF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859048
• Other study ID #: MAPLE-CHF
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: January 1, 2029

Study information

• Verified date: March 2024
• Source: Cardiology Research UBC
• Contact: Naomi Uchida, BSN
• Phone: 16048754521
• Email: naomi.uchida[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1360
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• NT-proBNP
blood sample to measure N-terminal prohormone of B-type natriuretic peptide at local laboratory
• AI echocardiogram
Artificial intelligence driven transthoracic echocardiogram
• electrocardiogram
tracing of electrical cardiac activity of the heart

Other:
• Cardiovascular physical examination
basic physiological measurements to include height (cm), weight (kg) and hip circumference (cm) and blood pressure (mmHg)

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	University of Sherbrooke	Sherbrooke	Quebec
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (7)

Lead Sponsor	Collaborator
Cardiology Research UBC	AstraZeneca, Canadian Heart Function Alliance, Centre for Cardiovascular Innovation, HeartLife Foundation, Montreal Heart Institute, NHS Greater Glasgow & Clyde

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of outpatient HF visits	Number of outpatient visits for HF with initiation or intensification of oral HF therapy	enrollment to six months
Primary	Number of urgent HF visit	Incidence of HF presentation in urgent care setting with administration of intravenous HF therapies	enrollment to six months
Primary	Number of HF hospitalizations	Number of admission for HF	enrollment to six months
Secondary	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
Secondary	HF events in HFrEF	number of HF admissions	enrollment to six months