NCT05919342

Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY "SYMPHONY-HF"

Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,904 (estimated)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is an international prospective, multicentre, unblinded, randomised-controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients.

Detailed description

The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure (HF) in high-risk patients. Participants will be recruited from 5-countries (Denmark, Canada, United States of America, Sweden and Scotland). Individual patient data from similar national randomised controlled trials that are independently powered for different efficacy endpoints will be pooled, harmonised and analysed. After agreeing to consent, patients will be randomised to one of two arms: "Routine care arm" - patients in this arm will undergo routine care. They will be managed and followed up as per routine clinical care. They will be remotely monitored for HF events by follow up through electronic records and routinely collected data. OR "Investigational arm" - patients in this arm will have a blood sample performed for measurement of N-terminal prohormone of B-type natriuretic peptide (NT-proBNP). Patients with an elevated Roche NT-proBNP (≥125 pg/mL) will undergo a transthoracic echocardiogram, clinical examination for signs of HF, HF symptom assessment, an ECG). Patients will undergo echocardiography with a CE-marked, FDA-approved handheld point of care (POC) EchoNous echocardiogram device in all countries. The US2.ai algorithm (which is also CE-marked and FDA-approved) will generate an AI-automated echocardiogram report. In Scotland all patients will also undergo a conventional echocardiogram. Patients who are classified as having heart failure (Heart failure with reduced ejection fraction \[HFrEF\], Heart failure with moderately reduced ejection fraction \[HFmrEF\] and Heart failure with preserved ejection fraction \[HFpEF\]) will be referred for appropriate follow up. In all countries when a handheld echocardiogram reported by AI-automated software does not provide diagnostic images a conventional echocardiogram will be undertaken.

Conditions

• Heart Failure
• Cardiovascular Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	NT-proBNP	Patients will undergo an NT-proBNP which will guide their future involvement within the study. Patients with an NT-proBNP of ≥125 pg/mL will undergo transthoracic echocardiogram along with a clinical assessment - any diagnosis of HF will result in patients undergoing referral for initiation of guideline directed medical therapy (for HF).

Timeline

• Start date: 2022-12-22
• Primary completion: 2024-06-21
• Completion: 2032-12-21
• First posted: 2023-06-26
• Last updated: 2023-08-04

Locations

7 sites across 5 countries: United States, Canada, Denmark, Sweden, United Kingdom

Regulatory

• FDA-regulated device study