Heart FailureSYMPHONY-HFNCT05919342
Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY "SYMPHONY-HF"
A study testing NT-proBNP in people with Heart Failure and Cardiovascular Diseases, run by NHS Greater Glasgow and Clyde at 7 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure, Cardiovascular Diseases
- What is being tested?
- NT-proBNP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,904 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 22 Dec 2022to 21 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥40 years of age
- Informed consent
- Two or more of the following risk factors for heart failure:
- 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])
- An established diagnosis of diabetes (type 1 or type 2)
- Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
Show all 11Show fewer
- Previous ischemic or embolic stroke
- Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel).
- 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).
- Regular loop diuretic use (any dose at any dosing interval) for >30 days.
- 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).
Who cannot join
- 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
Trial locations and contacts
7 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 5 countries
Canada2 sites, 2 recruiting
- Not yet recruiting
University of Montreal
Montreal, Quebec
Anique Ducharme, anique.ducharme@umontreal.ca
- Not yet recruiting
University of British Columbia
Vancouver, British Columbia
Nathaniel Hawkins, nathawkins@hotmail.com
Sweden2 sites, 2 recruiting
- Not yet recruiting
Karolinska University Hospital
Stockholm
Lars Lund, lars.lund@alumni.duke.edu
- Not yet recruiting
Uppsala University
Uppsala
Johan Sundström, johan.sundstrom@uu.se
United States1 site, 1 recruiting
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Nancy Albert, albertn@ccf.org
Denmark1 site, 1 recruiting
- Not yet recruiting
Rigshospitalet, Copenhagen University Hospital
Copenhagen
Lars Køber, lars.koeber.01@regionh.dk
United Kingdom1 site, 1 recruiting
- Recruiting
University of Glasgow
Glasgow, Scotland, G12 8TD
Mark C Petrie, MbChB, +44(0) 141 330 2677, mark.petrie@glasgow.ac.uk
F
About this study
Official title: 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.
Read the 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
- Being tested
- NT-proBNP
- Keywords
- Screening, Biomarker, NT-proBNP, Echocardiography, Community, Registry
- Medical subject headings
- Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-proBNPDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Routine care arm | No intervention | 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. |
| Investigational arm | Experimental | 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. Receives: Diagnostic Test: NT-proBNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of heart failure within 6 months
Measured: 6 months
Secondary outcomes (2)
Diagnosis of HFrEF within 6 months
Measured: 6 months
People diagnosed with HFrEF receiving GDMT within 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start22 Dec 2022
- Primary completion21 Jun 2024 (estimated)
- Study completion21 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After agreeing to consent, patients will be randomised 1:1 to one of two arms; a "Routine care arm" in which patients will undergo routine care or a 2. "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.
- Masking
- None (open label)
- Enrolment
- 3,904 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, National Heart Centre Singapore, Karolinska University Hospital, Uppsala University, Montreal Heart Institute, Copenhagen University Hospital, Rigshospitalet, University of British Columbia, The Cleveland Clinic, Université de Montréal, AstraZeneca, Roche Pharma AG, Us2.ai
- Responsible party
- Sponsor
- Investigators
- Mark C Petrie, MbChB, Principal investigator, University of GlasgowCarolyn SP Lam, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919342
- Sponsor's protocol ID
- 1
- Acronym
- SYMPHONY-HF
- Status last verified
- Aug 2023
- First submitted
- 21 May 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY
- ClinicalTrials.gov ID
- NCT05919342
- Acronym / sponsor ID
- SYMPHONY-HF / 1
- Conditions
- Heart Failure, Cardiovascular Diseases
- Keywords
- Screening, Biomarker, NT-proBNP, Echocardiography, Community, Registry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,904 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow, National Heart Centre Singapore, Karolinska University Hospital, Uppsala University, Montreal Heart Institute, Copenhagen University Hospital, Rigshospitalet, University of British Columbia, The Cleveland Clinic, Université de Montréal, AstraZeneca, Roche Pharma AG, Us2.ai
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 21 Jun 2024 (estimated)
- Study completion
- 21 Dec 2032 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After agreeing to consent, patients will be randomised 1:1 to one of two arms; a "Routine care arm" in which patients will undergo routine care or a 2. "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.
| Arm | Type | Receives |
|---|---|---|
| Routine care arm | No intervention | –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. |
| Investigational arm | Experimental | Diagnostic Test: NT-proBNPPatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female ≥40 years of age
- Informed consent
- Two or more of the following risk factors for heart failure:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-proBNPPatients 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). | Diagnostic test | Investigational arm |
Primary outcome
Diagnosis of heart failure within 6 months
Time frame: 6 months
2 secondary outcomes
Diagnosis of HFrEF within 6 months
Time frame: 6 months
People diagnosed with HFrEF receiving GDMT within 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark C Petrie, MbChB principal investigator
University of Glasgow
Carolyn SP Lam principal investigator
Duke-NUS Graduate Medical School
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NT-proBNP in people with Heart Failure and Cardiovascular Diseases, run by NHS Greater Glasgow and Clyde at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, Sweden, United States, Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark C Petrie, MbChB (+44(0) 141 330 2677, mark.petrie@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of heart failure within 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.