Cardiovascular DiseasesCARDIO-IMIDNCT06478277
UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry Study
An observational study of Cardiovascular Diseases and Immune-Mediated Inflammatory Diseases, run by University of Manchester at 2 sites in United Kingdom.
Trial summary
The goal of this observational study is to develop a large, deeply characterised cohort that will be a platform for collaborative clinical and translational research into cardiovascular (CV) disease (CVD) and Immune-mediated-inflammatory-diseases (IMID). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Immune-Mediated Inflammatory Diseases
- How many people
- 600 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 4 Feb 2026to Aug 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from NHS secondary care in the United Kingdom. Potential participants may be identified from clinics, wards, diagnostic pathways and departments, electronic and paper-based health records, databases and waiting lists in secondary care. All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation, except where the study inclusion and exclusion criteria explicitly state otherwise.
Who may be able to join
- Written informed consent
- Diagnosis of an IMID by a rheumatologist with categorisation into one of the following:
- IMID-'higher risk' CVD: individuals who have a risk of developing CVD (based on traditional risk factors and/or IMID-specific factors) but no history of CVD
- Coronary artery disease (CAD): specifically, a high pre-test probability of CAD based on clinical risk factors (e.g. QRISK3 score ≥10%) and/or elevated biochemical markers (high-sensitivity C-reactive protein ≥2mg/L and/or Lipoprotein(a) ≥70mg/dL)
- Myopericardial involvement: Specific IMID and/or cardiovascular indicators that place at increased risk e.g. autoantibody associations, presence of peripheral myositis or other major organ involvement; incidental raised serum cardiac biomarkers (troponin and/or NT-pro BNP), on routine testing
- Incident (new) IMID-CVD: Patients with IMID that present with a new history of CVD
Show all 26Show fewer
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- ASCVD i. Major adverse cardiovascular events (MACE):
- Non-fatal myocardial infarction.
- Non-fatal stroke of any classification, including reversible focal neurologic
- Defects with imaging evidence of a new cerebral lesion consistent with ischemia or haemorrhage.
- Other cardiovascular events not accounted for in the MACE-3 composite 2)a)i:
- Hospitalization for unstable angina
- Coronary revascularization
- Hospitalization for heart failure
- Transient Ischemic Attack (TIA)
- Peripheral Vascular Disease (PVD)
- Deep vein thrombosis (VTE) and/or pulmonary embolism [PE].
- Myopericardial involvement: as diagnosed by a cardiology specialist with 'tier 2' cardiovascular imaging and/or other clinical and biochemical criteria in line with usual care
- Established IMID-CVD
- Patients with IMID and a history of past cardiovascular event as detailed in 2) a) above.
- Patients with a known history of myopericardial involvement as defined above in 2) b)
- Biological sub-study inclusion criteria
- There are no additional inclusion criteria for this sub-study
- Extended protocol standard CMR sub-study inclusion criteria.
- Participants that receive a CMR scan as standard of care
Who cannot join
- Age less than 18 years
- Unable to give informed consent
- Biological sub-study exclusion criteria:
- There are no additional exclusion criteria for this sub-study
- CMR sub-study exclusion criteria:
- Standard of care contraindications to:
- CMR: metal implant eg metal fragments in the eye, pacemaker; claustrophobia; inability to lie flat
- Magnetic Resonance Imaging (MRI) contrast: renal failure with estimated glomerular filtration rate (eGFR) <30,
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Countess of Chester Hospital NHS Foundation Trust
Chester, CH2 1UL
Judith Prince, jude.prince@nhs.net
Theresa Barnes, theresa.barnes@nhs.net
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4SA
Hannah Castello, hannah.costello@ed.ac.uk
Marc Dweck, marc.dweck@ed.ac.uk
About this study
Official title: The UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry
The goal of this observational study is to develop a large, deeply characterised cohort that will be a platform for collaborative clinical and translational research into cardiovascular (CV) disease (CVD) and Immune-mediated-inflammatory-diseases (IMID). The main aim is to evaluate whether existing blood cardiac biomarkers predict adverse cardiovascular outcomes. The study will capture standard of care CV and associated health data (clinical, biochemistry/pathology and investigations) in patients across the IMIDs. Optional biological and/or imaging sub-studies will provide additional data and/or samples for associated analyses.
Read the detailed description
Multimorbidity is a rapidly growing burden on our healthcare systems, especially with an ageing demographic. CVD is a major cause of morbidity and mortality. The co-association of IMIDs with CVD needs more sophisticated understanding of the underlying risk, earlier identification and tailored use of targeted therapeutics. Importantly, the investigation of CVD in IMID offers an effective human experimental model to improve not just the lives of people with IMIDs but also the general CVD population.
The UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) registry will be a key platform for United Kingdom (UK) multi-centre clinical and translational CARDIO-IMID research. The aim is that centres across the UK including all the devolved nations will collaborate and contribute patients such that the registry will provide deep phenotyping, linked to clinical outcomes, in, ultimately, many hundreds of patients. The planned study will establish a deeply phenotyped cohort and/or as part of the optional sub-study, an associated bioresource to support individual discrete studies and/or analyses that address the stated aims and objectives. All potential participants will be invited to participate in the longitudinal collection and evaluation of routine comprehensive clinical information, including pathology, imaging and other cardiovascular data. This programme will identify patients within defined IMID clinical cohorts at different stages of (rheumatology and cardiovascular) disease. These data will be invaluable in enabling a full characterisation of CVD in terms of the extent, presentation, risk factors, and pathophysiology. Patients are seen as per standard clinical practice determined by the index IMID and in this setting, also dependent on co-existing CV comorbidity, usually every 3-6 months at time of IMID/CVD diagnosis and then 6 to 12 monthly thereafter. Specific questionnaires and tests requested outside of standard of care (sub-studies) will depend on disease group and clinical context. Not all patients will be required to complete all the relevant questionnaires, instead, based on individual IMID and/or CVD profile.
In addition, there is the opportunity for subjects to include (i) longitudinal biological (blood) samples and (ii) extended cardiovascular magnetic resonance (CMR) imaging protocol for those receiving CMR as part of National Health Service (NHS) standard of care.
Collectively, the study and associated platform with appropriate biostatistical and machine learning approaches will inform on the pathophysiological sequence of events, identification of prognostic biomarkers and risk models; as well as enable evaluation of the influence of IMID-specific vascular +/- immunosuppressive therapies and traditional cardiac pharmacotherapy where indicated. It will also establish a platform for trials in IMIDs to capture CV outcomes. Moreover, it will provide cohorts of patients readily available for recruitment, with linkage in place for outcomes. It could be used to leverage commercial funding and participation, facilitated by simplified, single-point access for industry. It will enable scaled investigation aimed at understanding causes of CARDIO-IMID, improving risk stratification and providing better care.
- Keywords
- Cardiovascular disease, Immune-mediated Inflammatory Diseases, Registry
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with abnormal high-sensitivity cardiac troponin I/T levels
The total number of participants with abnormal high-sensitivity troponin I/T levels (assessed by blood draw) will be measured.
Unit: number of participants
Measured: 5 years
Number of participants with abnormal N-terminal pro B-type natriuretic peptide (NT-pro BNP) levels
The total number of participants with abnormal NT-pro BNP levels (assessed by blood draw) will be measured.
Unit: number of participants
Measured: 5 years
Secondary outcomes (12)
Number of participants with atherosclerotic cardiovascular disease (ASCVD)
Total number of participants with ASCVD
ASCVD: Death due to acute myocardial infarction (MI), Sudden cardiac death, Death due to heart failure, Death due to stroke, Death due to cardiovascular procedures, Death due to cardiovascular haemorrhage, Death due to other cardiovascular causes: peripheral artery disease, Non-fatal MI, Non-fatal stroke of any classification, including reversible focal neurologic, defects with imaging evidence of a new cerebral lesion consistent with ischemia or haemorrhage.
Unit: number of participants
Measured: 5 years
Number of participants with myopericardial involvement
Total number of participants with primary myocardial events such as myocarditis, pericarditis.
Units: number of participants
Measured: 5 years
Number of participants with other cardiovascular events
The total number of participants with other cardiovascular events not already accounted for: Hospitalization for unstable angina; Coronary revascularization; Hospitalization for heart failure; Transient ischemic attack (TIA); Peripheral vascular disease (PVD); Venous thromboembolism (VTE) (deep vein thrombosis and/or pulmonary embolism [PE], all-cause mortality).
Units: number of participants
Measured: 5 years
Atrial and ventricular volumetrics
Atrial and ventricular volumetrics will be continuously measured. Mean and median values will be reported.
Units: mL/m2
Measured: 5 years
Systolic and diastolic function
Systolic and diastolic function will be continuously measured. Mean values will be reported.
Units: %
Measured: 5 years
Abnormalities in regional wall motion
Abnormalities in regional wall motion will be reported as a descriptive measure.
Unit: no units (descriptive measure of either: normal, hypokinetic (reduced endocardial excursion and wall thickening), akinetic (absent endocardial excursion and wall thickening) or diskinetic (systolic bulging with no thickening))
Measured: 5 years
Global longitudinal strain
Global longitudinal strain will be continuously measured. Mean values will be reported.
Units: %
Measured: 5 years
T2 relaxation time
T2 relaxation time will be continuously measured in participants undergoing cardiac magnetic resonance imaging as an indicator of myocardial inflammation. Mean and median values will be reported.
Unit: ms
Measured: 5 years
Late gadolinium enhancement
Late gadolinium enhancement will be measured in participants undergoing cardiac magnetic resonance imaging as an indicator for the presence and extent of replacement fibrosis.
Unit: no units (reported as either: presence or absence)
Measured: 5 years
T1 relaxation time
T1 relaxation time will be continuously measured in participants undergoing cardiac magnetic resonance imaging as an indicator for the presence and extent of replacement fibrosis. Mean and median values will be reported.
Unit: ms
Measured: 5 years
Extracellular volume fraction
Extracellular volume fraction will be continuously measured in participants undergoing cardiac magnetic resonance imaging as an indicator for the presence and extent of replacement fibrosis. Mean values will be reported.
Unit: %
Measured: 5 years
Aortic distensibility
Aortic distensibility will be continuously measured in participants undergoing cardiac magnetic resonance imaging. Mean and median values will be reported.
Unit: mm/Hg
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start4 Feb 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, University of Oxford, University of Edinburgh, University of Leeds, Imperial College London, Medical Research Council, British Heart Foundation, Swansea University, British Heart Foundation Data Science Centre
- Responsible party
- Principal investigator, Prof. Maya H. Buch, University of Manchester
- Investigators
- Maya H Buch, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478277
- Sponsor's protocol ID
- 341045
- Acronym
- CARDIO-IMID
- Status last verified
- Feb 2026
- First submitted
- 10 Jun 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known as to whether individual participant data (IPD) will be made available, as data will be released upon approval of application to the executive steering committee to release cohort data.
Publications
Luscher TF. Heart failure: the cardiovascular epidemic of the 21st century. Eur Heart J. 2015 Feb 14;36(7):395-7. doi: 10.1093/eurheartj/ehv004. No abstract available.
PubMed 25681826Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
PubMed 27206819Chang PP, Wruck LM, Shahar E, Rossi JS, Loehr LR, Russell SD, Agarwal SK, Konety SH, Rodriguez CJ, Rosamond WD. Trends in Hospitalizations and Survival of Acute Decompensated Heart Failure in Four US Communities (2005-2014): ARIC Study Community Surveillance. Circulation. 2018 Jul 3;138(1):12-24. doi: 10.1161/CIRCULATIONAHA.117.027551. Epub 2018 Mar 8.
PubMed 29519849Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.
PubMed 16855265Lewis GA, Schelbert EB, Williams SG, Cunnington C, Ahmed F, McDonagh TA, Miller CA. Biological Phenotypes of Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2017 Oct 24;70(17):2186-2200. doi: 10.1016/j.jacc.2017.09.006.
PubMed 29050567Yusuf S, Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJ, Michelson EL, Olofsson B, Ostergren J; CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial. Lancet. 2003 Sep 6;362(9386):777-81. doi: 10.1016/S0140-6736(03)14285-7.
PubMed 13678871Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
PubMed 19001508Redfield MM, Chen HH, Borlaug BA, Semigran MJ, Lee KL, Lewis G, LeWinter MM, Rouleau JL, Bull DA, Mann DL, Deswal A, Stevenson LW, Givertz MM, Ofili EO, O'Connor CM, Felker GM, Goldsmith SR, Bart BA, McNulty SE, Ibarra JC, Lin G, Oh JK, Patel MR, Kim RJ, Tracy RP, Velazquez EJ, Anstrom KJ, Hernandez AF, Mascette AM, Braunwald E; RELAX Trial. Effect of phosphodiesterase-5 inhibition on exercise capacity and clinical status in heart failure with preserved ejection fraction: a randomized clinical trial. JAMA. 2013 Mar 27;309(12):1268-77. doi: 10.1001/jama.2013.2024.
PubMed 23478662Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. doi: 10.1056/NEJMoa1313731.
PubMed 24716680Redfield MM, Anstrom KJ, Levine JA, Koepp GA, Borlaug BA, Chen HH, LeWinter MM, Joseph SM, Shah SJ, Semigran MJ, Felker GM, Cole RT, Reeves GR, Tedford RJ, Tang WH, McNulty SE, Velazquez EJ, Shah MR, Braunwald E; NHLBI Heart Failure Clinical Research Network. Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2015 Dec 10;373(24):2314-24. doi: 10.1056/NEJMoa1510774. Epub 2015 Nov 8.
PubMed 26549714Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.
PubMed 31475794Shah SJ. Precision Medicine for Heart Failure with Preserved Ejection Fraction: An Overview. J Cardiovasc Transl Res. 2017 Jun;10(3):233-244. doi: 10.1007/s12265-017-9756-y. Epub 2017 Jun 5.
PubMed 28585183Zile MR, Gottdiener JS, Hetzel SJ, McMurray JJ, Komajda M, McKelvie R, Baicu CF, Massie BM, Carson PE; I-PRESERVE Investigators. Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction. Circulation. 2011 Dec 6;124(23):2491-501. doi: 10.1161/CIRCULATIONAHA.110.011031. Epub 2011 Nov 7.
PubMed 22064591Shah AM, Claggett B, Sweitzer NK, Shah SJ, Anand IS, O'Meara E, Desai AS, Heitner JF, Li G, Fang J, Rouleau J, Zile MR, Markov V, Ryabov V, Reis G, Assmann SF, McKinlay SM, Pitt B, Pfeffer MA, Solomon SD. Cardiac structure and function and prognosis in heart failure with preserved ejection fraction: findings from the echocardiographic study of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) Trial. Circ Heart Fail. 2014 Sep;7(5):740-51. doi: 10.1161/CIRCHEARTFAILURE.114.001583. Epub 2014 Aug 13.
PubMed 25122186Cohen JB, Schrauben SJ, Zhao L, Basso MD, Cvijic ME, Li Z, Yarde M, Wang Z, Bhattacharya PT, Chirinos DA, Prenner S, Zamani P, Seiffert DA, Car BD, Gordon DA, Margulies K, Cappola T, Chirinos JA. Clinical Phenogroups in Heart Failure With Preserved Ejection Fraction: Detailed Phenotypes, Prognosis, and Response to Spironolactone. JACC Heart Fail. 2020 Mar;8(3):172-184. doi: 10.1016/j.jchf.2019.09.009. Epub 2020 Jan 8.
PubMed 31926856
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry
- ClinicalTrials.gov ID
- NCT06478277
- Acronym / sponsor ID
- CARDIO-IMID / 341045
- Keywords
- Cardiovascular disease, Immune-mediated Inflammatory Diseases, Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- University of Cambridge, University of Oxford, University of Edinburgh, University of Leeds, Imperial College London, Medical Research Council, British Heart Foundation, Swansea University, British Heart Foundation Data Science Centre
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 27 Jun 2024 (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.
The goal of this observational study is to develop a large, deeply characterised cohort that will be a platform for collaborative clinical and translational research into cardiovascular (CV) disease (CVD) and Immune-mediated-inflammatory-diseases (IMID). The main aim is to evaluate whether existing blood cardiac biomarkers predict adverse cardiovascular outcomes. The study will capture standard of care CV and associated health data (clinical, biochemistry/pathology and investigations) in patients across the IMIDs. Optional biological and/or imaging sub-studies will provide additional data and/or samples for associated analyses.
Detailed description
Multimorbidity is a rapidly growing burden on our healthcare systems, especially with an ageing demographic. CVD is a major cause of morbidity and mortality. The co-association of IMIDs with CVD needs more sophisticated understanding of the underlying risk, earlier identification and tailored use of targeted therapeutics. Importantly, the investigation of CVD in IMID offers an effective human experimental model to improve not just the lives of people with IMIDs but also the general CVD population.
The UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) registry will be a key platform for United Kingdom (UK) multi-centre clinical and translational CARDIO-IMID research. The aim is that centres across the UK including all the devolved nations will collaborate and contribute patients such that the registry will provide deep phenotyping, linked to clinical outcomes, in, ultimately, many hundreds of patients. The planned study will establish a deeply phenotyped cohort and/or as part of the optional sub-study, an associated bioresource to support individual discrete studies and/or analyses that address the stated aims and objectives. All potential participants will be invited to participate in the longitudinal collection and evaluation of routine comprehensive clinical information, including pathology, imaging and other cardiovascular data. This programme will identify patients within defined IMID clinical cohorts at different stages of (rheumatology and cardiovascular) disease. These data will be invaluable in enabling a full characterisation of CVD in terms of the extent, presentation, risk factors, and pathophysiology. Patients are seen as per standard clinical practice determined by the index IMID and in this setting, also dependent on co-existing CV comorbidity, usually every 3-6 months at time of IMID/CVD diagnosis and then 6 to 12 monthly thereafter. Specific questionnaires and tests requested outside of standard of care (sub-studies) will depend on disease group and clinical context. Not all patients will be required to complete all the relevant questionnaires, instead, based on individual IMID and/or CVD profile.
In addition, there is the opportunity for subjects to include (i) longitudinal biological (blood) samples and (ii) extended cardiovascular magnetic resonance (CMR) imaging protocol for those receiving CMR as part of National Health Service (NHS) standard of care.
Collectively, the study and associated platform with appropriate biostatistical and machine learning approaches will inform on the pathophysiological sequence of events, identification of prognostic biomarkers and risk models; as well as enable evaluation of the influence of IMID-specific vascular +/- immunosuppressive therapies and traditional cardiac pharmacotherapy where indicated. It will also establish a platform for trials in IMIDs to capture CV outcomes. Moreover, it will provide cohorts of patients readily available for recruitment, with linkage in place for outcomes. It could be used to leverage commercial funding and participation, facilitated by simplified, single-point access for industry. It will enable scaled investigation aimed at understanding causes of CARDIO-IMID, improving risk stratification and providing better care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from NHS secondary care in the United Kingdom. Potential participants may be identified from clinics, wards, diagnostic pathways and departments, electronic and paper-based health records, databases and waiting lists in secondary care. All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation, except where the study inclusion and exclusion criteria explicitly state otherwise.
Key inclusion criteria (26 listed)
- Written informed consent
- Diagnosis of an IMID by a rheumatologist with categorisation into one of the following:
- <!-- -->
- Biological sub-study inclusion criteria
- There are no additional inclusion criteria for this sub-study
Key exclusion criteria (8 listed)
- Age less than 18 years
- Unable to give informed consent
- There are no additional exclusion criteria for this sub-study
- CMR: metal implant eg metal fragments in the eye, pacemaker; claustrophobia; inability to lie flat
- Magnetic Resonance Imaging (MRI) contrast: renal failure with estimated glomerular filtration rate (eGFR) <30,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with abnormal high-sensitivity cardiac troponin I/T levels
Time frame: 5 years
The total number of participants with abnormal high-sensitivity troponin I/T levels (assessed by blood draw) will be measured. Unit: number of participants
Number of participants with abnormal N-terminal pro B-type natriuretic peptide (NT-pro BNP) levels
Time frame: 5 years
The total number of participants with abnormal NT-pro BNP levels (assessed by blood draw) will be measured. Unit: number of participants
12 secondary outcomes
Number of participants with atherosclerotic cardiovascular disease (ASCVD)
Time frame: 5 years
Number of participants with myopericardial involvement
Time frame: 5 years
Number of participants with other cardiovascular events
Time frame: 5 years
Atrial and ventricular volumetrics
Time frame: 5 years
Systolic and diastolic function
Time frame: 5 years
Abnormalities in regional wall motion
Time frame: 5 years
Global longitudinal strain
Time frame: 5 years
T2 relaxation time
Time frame: 5 years
Late gadolinium enhancement
Time frame: 5 years
T1 relaxation time
Time frame: 5 years
Extracellular volume fraction
Time frame: 5 years
Aortic distensibility
Time frame: 5 years
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 6 Feb 2026.
- Background: PubMed 25681826Luscher TF. Heart failure: the cardiovascular epidemic of the 21st century. Eur Heart J. 2015 Feb 14;36(7):395-7. doi: 10.1093/eurheartj/ehv004. No abstract available.
- Background: PubMed 27206819Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
- Background: PubMed 29519849Chang PP, Wruck LM, Shahar E, Rossi JS, Loehr LR, Russell SD, Agarwal SK, Konety SH, Rodriguez CJ, Rosamond WD. Trends in Hospitalizations and Survival of Acute Decompensated Heart Failure in Four US Communities (2005-2014): ARIC Study Community Surveillance. Circulation. 2018 Jul 3;138(1):12-24. doi: 10.1161/CIRCULATIONAHA.117.027551. Epub 2018 Mar 8.
- Background: PubMed 16855265Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.
- Background: PubMed 29050567Lewis GA, Schelbert EB, Williams SG, Cunnington C, Ahmed F, McDonagh TA, Miller CA. Biological Phenotypes of Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2017 Oct 24;70(17):2186-2200. doi: 10.1016/j.jacc.2017.09.006.
- Background: PubMed 13678871Yusuf S, Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJ, Michelson EL, Olofsson B, Ostergren J; CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial. Lancet. 2003 Sep 6;362(9386):777-81. doi: 10.1016/S0140-6736(03)14285-7.
- Background: PubMed 19001508Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
- Background: PubMed 23478662Redfield MM, Chen HH, Borlaug BA, Semigran MJ, Lee KL, Lewis G, LeWinter MM, Rouleau JL, Bull DA, Mann DL, Deswal A, Stevenson LW, Givertz MM, Ofili EO, O'Connor CM, Felker GM, Goldsmith SR, Bart BA, McNulty SE, Ibarra JC, Lin G, Oh JK, Patel MR, Kim RJ, Tracy RP, Velazquez EJ, Anstrom KJ, Hernandez AF, Mascette AM, Braunwald E; RELAX Trial. Effect of phosphodiesterase-5 inhibition on exercise capacity and clinical status in heart failure with preserved ejection fraction: a randomized clinical trial. JAMA. 2013 Mar 27;309(12):1268-77. doi: 10.1001/jama.2013.2024.
- Background: PubMed 24716680Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. doi: 10.1056/NEJMoa1313731.
- Background: PubMed 26549714Redfield MM, Anstrom KJ, Levine JA, Koepp GA, Borlaug BA, Chen HH, LeWinter MM, Joseph SM, Shah SJ, Semigran MJ, Felker GM, Cole RT, Reeves GR, Tedford RJ, Tang WH, McNulty SE, Velazquez EJ, Shah MR, Braunwald E; NHLBI Heart Failure Clinical Research Network. Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2015 Dec 10;373(24):2314-24. doi: 10.1056/NEJMoa1510774. Epub 2015 Nov 8.
- Background: PubMed 31475794Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.
- Background: PubMed 28585183Shah SJ. Precision Medicine for Heart Failure with Preserved Ejection Fraction: An Overview. J Cardiovasc Transl Res. 2017 Jun;10(3):233-244. doi: 10.1007/s12265-017-9756-y. Epub 2017 Jun 5.
- Individual participant dataSharing planned: Undecided. It is not yet known as to whether individual participant data (IPD) will be made available, as data will be released upon approval of application to the executive steering committee to release cohort data.
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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.
Maya H Buch, MD principal investigator
University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Immune-Mediated Inflammatory Diseases, run by University of Manchester 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 26 inclusion and 8 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 6 Feb 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?
Contact Georgia Reeves (+44 161 306 5600, georgia.reeves@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with abnormal high-sensitivity cardiac troponin I/T levels (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT06478277, which also lists 20 linked publications.
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 6 Feb 2026.