CM3 Study - Version 1

• Research type

  Research Study

• Full title

  The process of inflammation in the development of myocardial fibrosis in Chronic Kidney Disease and End Stage Renal Failure - A longitudinal cohort study assessing myocardial fibrosis development using Cardiac MRI correlated with monocyte and biochemical profile analysis during transition to renal replacement therapy

• IRAS ID

  221424

• Contact name

  Neill Duncan

• Contact email

  neill.duncan@nhs.net

• Sponsor organisation

  Imperial College London and Imperial College Healthcare NHS Trust

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  Title
  The role of inflammation in the development of myocardial fibrosis in Chronic Kidney Disease and End Stage Renal Failure - A longitudinal cohort study assessing myocardial fibrosis development with Cardiac MRI combined with monocyte and biochemical profile analysis

  Design
  Prospective cohort observational study

  Hypothesis
  Myocardial fibrosis and dysfunction is associated with renal replacement therapy and altered monocyte phenotype and function in end stage renal failure

  Aims
  To assess how chronic kidney disease stage and renal replacement modality modulates the monocyte and biochemical phenotype of patients and is associated with the development of fibrotic changes in the myocardium, resulting in changes of cardiac phenotype and function

  Outcome Measures
  Assessment of the development of myocardial fibrosis and change in cardiac function using sequential cardiac MRI imaging and assessment of associated changes in biochemical and monocyte phenotype

  Population
  This will be an observational study examining a prospective cohort of subjects with progressive chronic kidney disease (stage 4 and above) with a progressive decline in function and planned to start renal replacement therapy (either Heamodialysis or Peritoneal Dialysis)

  Eligibility
  Adults (18+) with chronic kidney disease stage 4 and above having undergone standard of care assessment for exclusion of macrovascular cardiac disease within the 3 years preceding recruitment. Subjects with diabetes, current metformin use, recent acute coronary syndrome, immunosuppressant therapy, or immune-mediated diseases will be excluded.

  Duration
  From recruitment at CKD 4 until 6-12 months from commencement on renal replacement therapy

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  18/SC/0703

• Date of REC Opinion

  10 Jan 2019

• REC opinion

  Further Information Favourable Opinion