HEROIC: a 5-year observational cohort study aimed at identifying novel factors that drive diabetic kidney disease: rationale and study protocol.

Autor:	Mccafferty K; Department of Nephrology, Barts Health NHS Trust, London, UK., Caplin B; Centre for Nephrology, University College London Medical School, London, UK., Knight S; Department of Discovery Biology, Discovery Sciences, R&D, AstraZeneca UK Ltd, Cambridge, Cambridgeshire, UK., Hockings P; Antaros Medical, Gothenburg, Sweden.; MedTech West, Chalmers University of Technology, Goteborg, Sweden., Wheeler D; Centre for Nephrology, University College London Medical School, London, UK., Fan SL; Department of Nephrology, Barts Health NHS Trust, London, UK., Hulthe J; Antaros Medical, Gothenburg, Sweden., Kleta R; Divison of Medicine, University College London, London, UK., Ashman N; Department of Nephrology, Barts Health NHS Trust, London, UK., Papastefanou V; Barts Health NHS Trust, London, UK., Mehta H; Royal Free Hampstead NHS Trust, London, London, UK., Salama A; Divison of Medicine, University College London, London, UK., Hadzovic S; Department of BioPharma Early Biometrics and Statistical Innovation, AstraZeneca, Goteborg, Sweden., Chowdhury TA; Department of Diabetes and Metabolism, Barts Health NHS Trust, London, UK., Jarl L; Antaros Medical, Gothenburg, Sweden., Unwin R; Department of Early Clinical Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca UK Ltd, Cambridge, Cambridgeshire, UK., Challis B; Department of Translational Science & Experimental Medicine, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca UK Ltd, Cambridge, Cambridgeshire, UK., Sundgren AK; Department of Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.; Data Science & AI | BioPharma Early Biometrics and Statistical Innovation, AstraZeneca, Gothenburg, Sweden., Yaqoob MM; Department of Nephrology, Barts Health NHS Trust, London, UK m.m.yaqoob@qmul.ac.uk.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2020 Sep 09; Vol. 10 (9), pp. e033923. Date of Electronic Publication: 2020 Sep 09.
DOI:	10.1136/bmjopen-2019-033923
Abstrakt:	Introduction: Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease worldwide and a major cause of premature mortality in diabetes mellitus (DM). While improvements in care have reduced the incidence of kidney disease among those with DM, the increasing prevalence of DM means that the number of patients worldwide with DKD is increasing. Improved understanding of the biology of DKD and identification of novel therapeutic targets may lead to new treatments. A major challenge to progress has been the heterogeneity of the DKD phenotype and renal progression. To investigate the heterogeneity of DKD we have set up The East and North London Diabetes Cohort (HEROIC) Study, a secondary care-based, multiethnic observational study of patients with biopsy-proven DKD. Our primary objective is to identify histological features of DKD associated with kidney endpoints in a cohort of patients diagnosed with type 1 and type 2 DM, proteinuria and kidney impairment. Methods and Analysis: HEROIC is a longitudinal observational study that aims to recruit 500 patients with DKD at high-risk of renal and cardiovascular events. Demographic, clinical and laboratory data will be collected and assessed annually for 5 years. Renal biopsy tissue will be collected and archived at recruitment. Blood and urine samples will be collected at baseline and during annual follow-up visits. Measured glomerular filtration rate (GFR), echocardiography, retinal optical coherence tomography angiography and kidney and cardiac MRI will be performed at baseline and twice more during follow-up. The study is 90% powered to detect an association between key histological and imaging parameters and a composite of death, renal replacement therapy or a 30% decline in estimated GFR. Ethics and Dissemination: Ethical approval has been obtained from the Bloomsbury Research Ethics Committee (REC 18-LO-1921). Any patient identifiable data will be stored on a password-protected National Health Services N3 network with full audit trail. Anonymised imaging data will be stored in a ISO27001-certificated data warehouse.Results will be reported through peer-reviewed manuscripts and conferences and disseminated to participants, patients and the public using web-based and social media engagement tools as well as through public events. Competing Interests: Competing interests: BCh, RU, SK, SH and AKS are employees of AstraZeneca, and authors PH and JH are employees of Antaros Medical. (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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