HEROIC: a 5-year observational cohort study aimed at identifying novel factors that drive diabetic kidney disease: rationale and study protocol
Artikel i vetenskaplig tidskrift, 2020

Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 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.

magnetic resonance imaging

diabetic Kidney disease

cohort study

histopathology

Författare

Kieran Mccafferty

Barts Health NHS Trust

Ben Caplin

University College London (UCL)

Sinead Knight

AstraZeneca AB

Paul Hockings

Chalmers, Elektroteknik, Signalbehandling och medicinsk teknik, Biomedicinsk elektromagnetik

MedTech West

Antaros Medical AB

David Wheeler

University College London (UCL)

Stanley L. Fan

Barts Health NHS Trust

Johannes Hulthe

Antaros Medical AB

Robert Kleta

University College London (UCL)

Neil Ashman

Barts Health NHS Trust

Vasilios Papastefanou

Barts Health NHS Trust

Hemal Mehta

Royal Free London NHS Foundation Trust

Alan Salama

University College London (UCL)

Sinela Hadzovic

AstraZeneca AB

Tahseen Ahmad Chowdhury

Barts Health NHS Trust

Lisa Jarl

Antaros Medical AB

Robert Unwin

AstraZeneca AB

Benjamin Challis

AstraZeneca AB

Anna K. Sundgren

AstraZeneca AB

Muhammad Magdi Yaqoob

Barts Health NHS Trust

BMJ Open

2044-6055 (ISSN)

Vol. 10 9 e033923-

Ämneskategorier

Allmänmedicin

Urologi och njurmedicin

Kardiologi

DOI

10.1136/bmjopen-2019-033923

PubMed

32912939

Mer information

Senast uppdaterat

2020-10-12