Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY "SYMPHONY-HF"
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure 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 (HFrEF, HFmrEF and 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 Design
Arms and Interventions
| 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).
|
Outcome Measures
Primary Outcome Measures
- Diagnosis of heart failure within 6 months [6 months]
Secondary Outcome Measures
- Diagnosis of HFrEF within 6 months [6 months]
- People diagnosed with HFrEF receiving GDMT within 6 months [6 months]
Other Outcome Measures
- Diagnosis of HFmrEF within 6 months [6 months]
- Diagnosis of HFpEF within 6 months [6 months]
- People diagnosed with HFmrEF and HFpEF receiving SGLT2i therapy within 6 months [6 months]
- Diagnosis of asymptomatic left ventricular dysfunction (LVEF≤40%) within 6 months [6 months]
- Time to first heart failure hospitalisation at 1 year [1 year]
- Time to first heart failure hospitalisation at 2 years [2 years]
- Time to first heart failure hospitalisation at 5 years [5 years]
- All-cause mortality at 1 year [1 year]
- All-cause mortality at 2 years [2 years]
- All-cause mortality at 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 [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 [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 [5 years]
- The incremental cost-effectiveness ratio (ICER) will be expressed as incremental costs/life-year gained [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" [6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female ≥40 years of age
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Informed consent
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Two or more of the following risk factors for heart failure:
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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])
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An established diagnosis of diabetes (type 1 or type 2)
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Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
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Previous ischemic or embolic stroke
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Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel).
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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).
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Regular loop diuretic use (any dose at any dosing interval) for >30 days.
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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:
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Inability to give informed consent e.g., due to significant cognitive impairment
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Previous documented diagnosis of heart failure
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Current renal replacement therapy
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 2 | University of British Columbia | Vancouver | British Columbia | Canada | |
| 3 | University of Montreal | Montréal | Quebec | Canada | |
| 4 | Rigshospitalet, Copenhagen University Hospital | Copenhagen | Denmark | ||
| 5 | Karolinska University Hospital | Stockholm | Sweden | ||
| 6 | Uppsala University | Uppsala | Sweden | ||
| 7 | University of Glasgow | Glasgow | Scotland | United Kingdom | G12 8TD |
Sponsors and Collaborators
- NHS Greater Glasgow and Clyde
- University of Glasgow
- National Heart Centre Singapore
- Karolinska University Hospital
- Uppsala University
- Montreal Heart Institute
- Rigshospitalet, Denmark
- University of British Columbia
- The Cleveland Clinic
- Université de Montréal
- AstraZeneca
- Roche Pharma AG
Investigators
- Principal Investigator: Mark C Petrie, MbChB, University of Glasgow
- Principal Investigator: Carolyn SP Lam, Duke-NUS Graduate Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1