Heart FailureTARTAN-HFNCT05705869
Targeted Assessment in High-Risk paTients With dIAbetes to ideNtify Undiagnosed Heart Failure
A study testing NT-proBNP in people with Heart Failure and Diabetes Mellitus, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
Trial summary
This is a 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 with diabetes. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure, Diabetes Mellitus, Type 1 Diabetes
- What is being tested?
- NT-proBNP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 706 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 22 Dec 2022to 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
- An established diagnosis of diabetes (type 1 or type 2)
- At least one additional risk factor 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 or >70% left anterior descending, circumflex or right coronary artery])
- Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
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- 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.
- Echocardiogram or NT-proBNP interpreted as excluding heart failure within 12 months.
- Currently receiving scheduled 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
2 sites in 1 country.
United Kingdom2 sites
Glasgow Royal Infirmary
Glasgow, Scotland, G4 0SF
Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF
About this study
Official title: Targeted Assessment in High-Risk paTients With dIAbetes to ideNtify Undiagnosed Heart Failure (TARTAN-HF)
This is a 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 with diabetes.
Read the detailed description
This is a 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 with diabetes.
Participants will be recruited from the diabetes service in two NHS health boards in Scotland; NHS Greater Glasgow and Clyde and NHS Lanarkshire. At the point of recruitment and consent, patients will be randomised to one of two arms:
- "Routine care arm" - patients in this arm will undergo routine diabetes care. They will be managed and followed up as per routine clinical care. They will be remotely monitored for HF events electronically. Quality of life questionnaires (Kansas City Cardiomyopathy Questionnaire-12 and EQ-5D) will be completed electronically through CASTOR program in this arm (with the option of paper versions for participants who can not use CASTOR). OR
- "Investigational arm" - patients in this arm will have a blood sample taken to measure N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) using a Roche assay. In addition to this, blood samples for haemoglobin, creatinine, HbA1c, cholesterol profile, liver function tests and eGFR will be collected. Quality of life questionnaires (Kansas City Cardiomyopathy Questionnaire-12 and EQ-5D) will be completed electronically through CASTOR program in this arm (with the option of paper versions for participants who can not use CASTOR).
All patients in this arm will also have an ECG and basic body measurements and observations measured. Further venous blood samples will be collected and stored within Glasgow University storage facilities for future measurement of relevant biomarkers and for use in future ethically approved research. Urine samples will also be collected for measurement of urine albumin:creatinine ratio and for future measurement of relevant biomarkers and use in future ethically approved research.
Patients with an elevated Roche NT-proBNP (≥125 pg/mL) will undergo a full cart-based transthoracic echocardiogram along with a clinical examination for signs of HF and a HF symptom assessment. A British Society of Echocardiography minimum dataset will be obtained, and report created.
Patients will then also undergo a handheld echocardiogram with a UKCE-marked handheld point of care (POC) EchoNous Kosmos echocardiogram device. The handheld echocardiogram images will be acquired by a British Society of Echocardiography accredited operator. The US2.ai algorithm (which is also UKCE marked) will generate an AI-automated echocardiogram report.
Patients who are classified as having heart failure (HFrEF, HFmrEF, or HFpEF) will be managed according to the latest version of European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure. The results of the cart-based echocardiogram will be used during the determination of the presence or absence of HF.
- Conditions
- Heart Failure, Diabetes Mellitus, Type 1 Diabetes, Type 2 Diabetes, Cardiovascular Diseases
- Being tested
- NT-proBNP
- Keywords
- Screening, Primary Care, Secondary Care, NT-proBNP, Echocardiogram, Diagnostic Pathway
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-proBNPDiagnostic test
NT-proBNP will be measured in all participants in the Investigational arm. If the level of the NT-proBNP is elevated (≥125pg/mL) participants will undergo a full cart-based transthoracic echocardiogram along with a clinical examination for signs of HF and a HF symptom assessment. Participants with HF identified will be referred to their local HF clinic for ongoing management.
| Study group | Role | What they receive |
|---|---|---|
| Routine care arm | No intervention | Patients in this arm will undergo routine diabetes care. They will be managed and followed up as per routine clinical care. They will be remotely monitored for heart failure events electronically. Quality of life questionnaires (Kansas City Cardiomyopathy Questionnaire-12 and EQ-5D) will be collected. |
| Investigational arm | Experimental | Patients in this arm will have a blood sample taken to measure N-terminal prohormone of B-type natriuretic peptide (NT-proBNP).
In addition to this, routine blood samples, an ECG, body measurements, patient reported outcomes and observations will be recorded.
Further blood and urine samples will be collected and stored within Glasgow University storage facilities for future measurement of relevant biomarkers and for use in future ethically approved research.
Patients with an elevated NT-proBNP (≥125 pg/mL) will undergo a full cart-based transthoracic echocardiogram along with a clinical examination for signs of HF and a HF symptom assessment. Patients will then also undergo a handheld echocardiogram with a CE-marked handheld point of care EchoNous Kosmos echocardiogram device.
Patients who are classified as having heart failure (HFrEF, HFmrEF, or HFpEF) will be managed according to the latest version of European Society of Cardiology guidelines. 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 posted31 Jan 2023
- Study start22 Dec 2022
- Primary completion30 Nov 2025
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Mark C Petrie, MbChB, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705869
- Sponsor's protocol ID
- GN22CA228
- Acronym
- TARTAN-HF
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2022
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taylor-Sweet D, Petrie MC, McKinley G, McGlynn L, Jarvie J, Beazer J, Butler E, MacDonald E, Welsh P, Martinson M, Brooksbank K, Barnett A, Kerr J, Petrie CJ, Weir RAP, Gold ST, Hall L, Kennon B, Llano A, McKay G, Oroko M, Fagura M, Malvolti E, Sattar N, Campbell RT, McConnachie A, McMurray JJV, Lam CSP, Docherty KF. Targeted Assessment in High-Risk Patients With Diabetes to Identify Undiagnosed Heart Failure (TARTAN-HF). J Am Coll Cardiol. 2026 Aug 11:S0735-1097(26)07132-9. doi: 10.1016/j.jacc.2026.06.042. Online ahead of print.
PubMed 42615958
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Assessment in High-Risk paTients With dIAbetes to ideNtify Undiagnosed Heart Failure (TARTAN-HF)
- ClinicalTrials.gov ID
- NCT05705869
- Acronym / sponsor ID
- TARTAN-HF / GN22CA228
- Conditions
- Heart Failure, Diabetes Mellitus, Type 1 Diabetes, Type 2 Diabetes, Cardiovascular Diseases
- Keywords
- Screening, Primary Care, Secondary Care, NT-proBNP, Echocardiogram, Diagnostic Pathway
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 706 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- Dec 2032 (estimated)
- First posted
- 31 Jan 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 a 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 with diabetes.
Detailed description
This is a 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 with diabetes.
Participants will be recruited from the diabetes service in two NHS health boards in Scotland; NHS Greater Glasgow and Clyde and NHS Lanarkshire. At the point of recruitment and consent, patients will be randomised to one of two arms:
- "Routine care arm" - patients in this arm will undergo routine diabetes care. They will be managed and followed up as per routine clinical care. They will be remotely monitored for HF events electronically. Quality of life questionnaires (Kansas City Cardiomyopathy Questionnaire-12 and EQ-5D) will be completed electronically through CASTOR program in this arm (with the option of paper versions for participants who can not use CASTOR). OR
- "Investigational arm" - patients in this arm will have a blood sample taken to measure N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) using a Roche assay. In addition to this, blood samples for haemoglobin, creatinine, HbA1c, cholesterol profile, liver function tests and eGFR will be collected. Quality of life questionnaires (Kansas City Cardiomyopathy Questionnaire-12 and EQ-5D) will be completed electronically through CASTOR program in this arm (with the option of paper versions for participants who can not use CASTOR).
All patients in this arm will also have an ECG and basic body measurements and observations measured. Further venous blood samples will be collected and stored within Glasgow University storage facilities for future measurement of relevant biomarkers and for use in future ethically approved research. Urine samples will also be collected for measurement of urine albumin:creatinine ratio and for future measurement of relevant biomarkers and use in future ethically approved research.
Patients with an elevated Roche NT-proBNP (≥125 pg/mL) will undergo a full cart-based transthoracic echocardiogram along with a clinical examination for signs of HF and a HF symptom assessment. A British Society of Echocardiography minimum dataset will be obtained, and report created.
Patients will then also undergo a handheld echocardiogram with a UKCE-marked handheld point of care (POC) EchoNous Kosmos echocardiogram device. The handheld echocardiogram images will be acquired by a British Society of Echocardiography accredited operator. The US2.ai algorithm (which is also UKCE marked) will generate an AI-automated echocardiogram report.
Patients who are classified as having heart failure (HFrEF, HFmrEF, or HFpEF) will be managed according to the latest version of European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure. The results of the cart-based echocardiogram will be used during the determination of the presence or absence of HF.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine care arm | No intervention | –Patients in this arm will undergo routine diabetes care. They will be managed and followed up as per routine clinical care. They will be remotely monitored for heart failure events electronically. Quality of life questionnaires (Kansas City Cardiomyopathy Questionnaire-12 and EQ-5D) will be collected. |
| Investigational arm | Experimental | Diagnostic Test: NT-proBNPPatients in this arm will have a blood sample taken to measure N-terminal prohormone of B-type natriuretic peptide (NT-proBNP). In addition to this, routine blood samples, an ECG, body measurements, patient reported outcomes and observations will be recorded. Further blood and urine samples will be collected and stored within Glasgow University storage facilities for future measurement of relevant biomarkers and for use in future ethically approved research. Patients with an elevated NT-proBNP (≥125 pg/mL) will undergo a full cart-based transthoracic echocardiogram along with a clinical examination for signs of HF and a HF symptom assessment. Patients will then also undergo a handheld echocardiogram with a CE-marked handheld point of care EchoNous Kosmos echocardiogram device. Patients who are classified as having heart failure (HFrEF, HFmrEF, or HFpEF) will be managed according to the latest version of European Society of Cardiology guidelines. |
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
- An established diagnosis of diabetes (type 1 or type 2)
- At least one additional risk factor for heart failure:
Key exclusion criteria (5 listed)
- Inability to give informed consent e.g., due to significant cognitive impairment.
- Previous documented diagnosis of heart failure.
- Echocardiogram or NT-proBNP interpreted as excluding heart failure within 12 months.
- Currently receiving scheduled 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-proBNPNT-proBNP will be measured in all participants in the Investigational arm. If the level of the NT-proBNP is elevated (≥125pg/mL) participants will undergo a full cart-based transthoracic echocardiogram along with a clinical examination for signs of HF and a HF symptom assessment. Participants with HF identified will be referred to their local HF clinic for ongoing management. | 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 14 Jan 2026.
- Derived from this study: PubMed 42615958Taylor-Sweet D, Petrie MC, McKinley G, McGlynn L, Jarvie J, Beazer J, Butler E, MacDonald E, Welsh P, Martinson M, Brooksbank K, Barnett A, Kerr J, Petrie CJ, Weir RAP, Gold ST, Hall L, Kennon B, Llano A, McKay G, Oroko M, Fagura M, Malvolti E, Sattar N, Campbell RT, McConnachie A, McMurray JJV, Lam CSP, Docherty KF. Targeted Assessment in High-Risk Patients With Diabetes to Identify Undiagnosed Heart Failure (TARTAN-HF). J Am Coll Cardiol. 2026 Aug 11:S0735-1097(26)07132-9. doi: 10.1016/j.jacc.2026.06.042. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mark C Petrie, MbChB principal investigator
University of Glasgow
2 sites in 1 country: 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 Diabetes Mellitus, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
On the ClinicalTrials.gov record for NCT05705869, which also lists 1 linked publication.
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 14 Jan 2026.