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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
NHS Greater Glasgow and Clyde
Study ID
NCT05919342
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NT-proBNP — DIAGNOSTIC_TEST
    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).

Study Details

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.

Key Dates

Start date
Dec 22, 2022
Status verified
Aug 2023
Primary completion
Jun 21, 2024
Completion
Dec 21, 2032

Study Design

Enrollment
3,904 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • No Intervention: 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.
  • Experimental: 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.

Primary Outcome Measure

Diagnosis of heart failure within 6 months [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Nancy Albert
[email protected]

Find similar trials in Cleveland, OH

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Cleveland Clinic· Cleveland, OH

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