Recruiting

Observational Study

Sponsor:

Cardiology Research UBC

Code:

NCT05859048

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

NT-proBNP

AI echocardiogram

electrocardiogram

Cardiovascular physical examination

Study Details

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

Conditions

Heart Failure

Study ID

NCT05859048

Start date

Mar 1, 2024

Status verified date

Mar, 2024

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Investigational arm guided by NT-proBNP result

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

no intervention: Routine care arm

Participants will be remotely monitored for number of heart failure events

Interventions

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

Cardiovascular physical examination

basic physiological measurements to include height (cm), weight (kg) and hip circumference (cm) and blood pressure (mmHg)

Primary outcome measure

  • Number of participants diagnosed with heart failure (HF) according to the European Society of Cardiology 2021 HF guidelines [ Time Frame: enrollment to six months ]
  • Number of outpatient HF visits [ Time Frame: enrollment to six months ]
  • Number of urgent HF visit [ Time Frame: enrollment to six months ]
  • Number of HF hospitalizations [ Time Frame: enrollment to six months ]

Central Contacts and Locations

Central contacts

Naomi Uchida, BSN

16048754521naomi.uchida@ubc.ca

Jennifer Petterson

604-875-5104jenny.petterson@vch.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Nathaniel Hawkins, MD

604-875-5264nat.hawkins@ubc.ca

More Information

Sponsor

Cardiology Research UBC

Last update posted

Mar 7, 2024

Last verified

Mar, 2024

Keywords

  • Heart failure screening
  • natriuretic peptides
  • artificial intelligence echocardiography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cardiology Research UBC on 2024-03-07.