HEROIC: a 5-year observational cohort study aimed at identifying novel factors that drive diabetic kidney disease: rationale and study protocol
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...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e033923.full |
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| author | Neil Ashman Ben Caplin David Wheeler Tahseen Ahmad Chowdhury Kieran Mccafferty Sinead Knight Paul Hockings Stanley L Fan Johannes Hulthe Robert Kleta Vasilios Papastefanou Hemal Mehta Alan Salama Sinela Hadzovic Lisa Jarl Robert Unwin Benjamin Challis Anna K Sundgren Muhammad Magdi Yaqoob |
| author_facet | Neil Ashman Ben Caplin David Wheeler Tahseen Ahmad Chowdhury Kieran Mccafferty Sinead Knight Paul Hockings Stanley L Fan Johannes Hulthe Robert Kleta Vasilios Papastefanou Hemal Mehta Alan Salama Sinela Hadzovic Lisa Jarl Robert Unwin Benjamin Challis Anna K Sundgren Muhammad Magdi Yaqoob |
| author_sort | Neil Ashman |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-85977b8c69d14eb298e98bcae07ec97a |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-85977b8c69d14eb298e98bcae07ec97a2025-01-08T09:05:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-033923HEROIC: a 5-year observational cohort study aimed at identifying novel factors that drive diabetic kidney disease: rationale and study protocolNeil Ashman0Ben Caplin1David Wheeler2Tahseen Ahmad Chowdhury3Kieran Mccafferty4Sinead Knight5Paul Hockings6Stanley L Fan7Johannes Hulthe8Robert Kleta9Vasilios Papastefanou10Hemal Mehta11Alan Salama12Sinela Hadzovic13Lisa Jarl14Robert Unwin15Benjamin Challis16Anna K Sundgren17Muhammad Magdi Yaqoob18Department of Nephrology, Barts Health NHS Trust, London, UK2University College London (UCL), Department of Renal Medicine, Royal Free Hospital, London, UKDepartment of Renal Medicine, University College London, London, UKconsultant in diabetes and metabolismDepartment of Nephrology, Barts Health NHS Trust, London, UKDepartment of Discovery Biology, Discovery Sciences, R&D, AstraZeneca UK Ltd, Cambridge, Cambridgeshire, UKAntaros Medical, Gothenburg, SwedenDepartment of Nephrology, Barts Health NHS Trust, London, UKAntaros Medical, Gothenburg, SwedenDivison of Medicine, University College London, London, UKBarts Health NHS Trust, London, UK1Macular Research Group, Save Sight Institute, University of Sydney, Sydney, AustraliaDivison of Medicine, University College London, London, UKDepartment of BioPharma Early Biometrics and Statistical Innovation, AstraZeneca, Goteborg, SwedenAntaros Medical, Gothenburg, SwedenDepartment of Early Clinical Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca UK Ltd, Cambridge, Cambridgeshire, UKDepartment of Translational Science & Experimental Medicine, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca UK Ltd, Cambridge, Cambridgeshire, UKDepartment of Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USADepartment of Nephrology, Barts Health NHS Trust, London, UKIntroduction 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.https://bmjopen.bmj.com/content/10/9/e033923.full |
| spellingShingle | Neil Ashman Ben Caplin David Wheeler Tahseen Ahmad Chowdhury Kieran Mccafferty Sinead Knight Paul Hockings Stanley L Fan Johannes Hulthe Robert Kleta Vasilios Papastefanou Hemal Mehta Alan Salama Sinela Hadzovic Lisa Jarl Robert Unwin Benjamin Challis Anna K Sundgren Muhammad Magdi Yaqoob HEROIC: a 5-year observational cohort study aimed at identifying novel factors that drive diabetic kidney disease: rationale and study protocol BMJ Open |
| title | HEROIC: a 5-year observational cohort study aimed at identifying novel factors that drive diabetic kidney disease: rationale and study protocol |
| title_full | HEROIC: a 5-year observational cohort study aimed at identifying novel factors that drive diabetic kidney disease: rationale and study protocol |
| title_fullStr | HEROIC: a 5-year observational cohort study aimed at identifying novel factors that drive diabetic kidney disease: rationale and study protocol |
| title_full_unstemmed | HEROIC: a 5-year observational cohort study aimed at identifying novel factors that drive diabetic kidney disease: rationale and study protocol |
| title_short | HEROIC: a 5-year observational cohort study aimed at identifying novel factors that drive diabetic kidney disease: rationale and study protocol |
| title_sort | heroic a 5 year observational cohort study aimed at identifying novel factors that drive diabetic kidney disease rationale and study protocol |
| url | https://bmjopen.bmj.com/content/10/9/e033923.full |
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