UGLA/ENSAT-HT_v1

• Research type

  Research Study

• Full title

  Performance of an omics-signature in the diagnosis and prognosis of endocrine and primary hypertension. A sub-study of the ENSAT-HT Horizon 2020 project

• IRAS ID

  222444

• Contact name

  Christian Delles

• Contact email

  Christian.Delles@glasgow.ac.uk

• Sponsor organisation

  NHS GGC

• Clinicaltrials.gov Identifier

  NCT02772315

• Clinicaltrials.gov Identifier

  633983, European Union’s Horizon 2020 research and innovation programme

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  Summary of Research

  The UGLA/ENSAT-HT is an observational multi-centre sub-study of the ENSAT-HT Horizon 2020 European project, which will compare the diagnostic performance of modern 'omics' techniques (genomics, metabolomics, proteomics of plasma and urine) with currently used, cumbersome diagnostic methods to detect endocrine (adrenal) forms of high blood pressure (EHBP) [phase 1]. In addition, we will explore whether omics might predict prognosis of patients that do not have an identifiable cause of hypertension, so-called primary hypertension (PHT), their cost-effectiveness and relation to the psycho-social burden of hypertension [Phase 2].
  Omics signature identified in an ongoing, retrospective phase will be prospectively validated comparing all consenting adult EHBP and matched PHT patients (≤ 75 yo) referred to each participating centre. Exclusion criteria will entail severe comorbidity, non-adrenal active malignancies, pregnancy and lack of capacity or of therapeutic adherence.
  Hypertensive patients referred to Glasgow Blood Pressure Clinic (GBPC) in the Queen Elizabeth University Hospital will be diagnosed and treated in keeping with usual diagnostic algorithms and care. The additional burden of participation is the sampling of extra blood and urine at the start of the usual diagnostic phase and at the end of a 1 year follow-up period, the collection of clinical data and filling out QoL questionnaires.
  A European Union’s Horizon 2020 research and innovation programme grant will fund the research.

  Summary of Results

  This prospective stage of the ENSAT-HT study, uses artificial intelligence (machine-learning based) analysis of several markers measured in the blood and urine to develop and validate a new system for diagnosis of high blood pressure caused by disorders in hormone production, with the intention of enabling quicker, more cost-effective diagnosis and treatment of patients with these conditions.
  All collection and measurements of study samples have now been made, completing our role in this specific project. Our data has been delivered to study partners in Dundee who are now performing the extensive analytical procedures required to validate specific diagnostic signatures. When complete, this work will be published in high profile scientific journals as is currently the case for the previous retrospective study phase of this project. More details about the study, the partners involved and the results to date can be found at https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbZVJccDzFh8IIKEa8ZLdNBwNuJPYz832IrXm2gFvw-2BNtkXJ6_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKX-2FoEl1cK84DHBzV3n2Dtt3lTDnkKcGWRcrI2XX0ErvYmjNuyTCpWbcrxDOubHRA6czUwXo7iTt19n3UScfgZKTJVp9GT-2Bc7s0VTN509dYGZyJkI2QID0LMHagjP7-2FD9itDh3HsJ04cjMXMkOHe1acz8qcXh3zdK0TGnTiSI7ykg-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C46ead4a9932842b2a35508dae1bd2aa8%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638070499821266229%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=YxJljuhxKSrE9Jg5fgptTVXEqQ7usZ6QCruWai9qRmY%3D&reserved=0

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  18/SC/0171

• Date of REC Opinion

  22 Mar 2018

• REC opinion

  Favourable Opinion