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

August 2, 2023 updated by: NHS Greater Glasgow and Clyde

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

3904

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female ≥40 years of age
  • Informed consent

  • Two or more of the following risk factors for heart failure:

    1. Coronary artery disease (either a previous documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis of an epicardial coronary artery [50% left main stem or >70% left anterior descending, circumflex or right coronary artery])
    2. An established diagnosis of diabetes (type 1 or type 2)
    3. Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
    4. Previous ischemic or embolic stroke
    5. Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel).
    6. Chronic kidney disease (defined as an estimated glomerular filtration rate <60mL/min/1.73m2 or eGFR 60-90mL/min/1.73m2 and UACR >300mg/g).
    7. Regular loop diuretic use (any dose at any dosing interval) for >30 days.
    8. COPD (evidenced by one of the following: PFTs showing airway obstruction, diagnosis by respiratory physician, CT scan reporting presence of emphysema or treatment with national guideline advocated COPD therapy).

Exclusion Criteria:

  • Inability to give informed consent e.g., due to significant cognitive impairment
  • Previous documented diagnosis of heart failure
  • Current renal replacement therapy
  • Anyone who, in the investigators' 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnosis of heart failure within 6 months
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Diagnosis of HFrEF within 6 months
Time Frame: 6 months
6 months
People diagnosed with HFrEF receiving GDMT within 6 months
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
All-cause mortality at 1 year
Time Frame: 1 year
1 year
Diagnosis of HFmrEF within 6 months
Time Frame: 6 months
6 months
Diagnosis of HFpEF within 6 months
Time Frame: 6 months
6 months
People diagnosed with HFmrEF and HFpEF receiving SGLT2i therapy within 6 months
Time Frame: 6 months
6 months
Diagnosis of asymptomatic left ventricular dysfunction (LVEF≤40%) within 6 months
Time Frame: 6 months
6 months
Time to first heart failure hospitalisation at 1 year
Time Frame: 1 year
1 year
Time to first heart failure hospitalisation at 2 years
Time Frame: 2 years
2 years
Time to first heart failure hospitalisation at 5 years
Time Frame: 5 years
5 years
All-cause mortality at 2 years
Time Frame: 2 years
2 years
All-cause mortality at 5 years
Time Frame: 5 years
5 years
Time to first occurence of any components of the following clinical composite 1) heart failure hospitalisation 2) all-cause mortality at 1 year
Time Frame: 1 year
1 year
Time to first occurence of any components of the following clinical composite 1) heart failure hospitalisation 2) all-cause mortality at 2 years
Time Frame: 2 years
2 years
Time to first occurence of any components of the following clinical composite 1) heart failure hospitalisation 2) all-cause mortality at 5 years
Time Frame: 5 years
5 years
The incremental cost-effectiveness ratio (ICER) will be expressed as incremental costs/life-year gained
Time Frame: 5 years
5 years
The number of patients in the NT-proBNP/echocardiography group with echocardiographic features of potential amyloid as assessed by the US2.ai algorithm report conclusion of "amyloid to be considered"
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

Karolinska University Hospital
University of British Columbia
Uppsala University
Roche Pharma AG
AstraZeneca
Rigshospitalet, Denmark
The Cleveland Clinic
Montreal Heart Institute
National Heart Centre Singapore
University of Glasgow
Université de Montréal
Us2.ai

Investigators

  • Principal Investigator: Mark C Petrie, MbChB, University of Glasgow
  • Principal Investigator: Carolyn SP Lam, Duke-NUS Graduate Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2022

Primary Completion (Estimated)

June 21, 2024

Study Completion (Estimated)

December 21, 2032

Study Registration Dates

First Submitted

May 21, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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