Heart Failure Clinical Trial
— CM3Official 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
Verified date | September 2021 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Firstly, this study aims to understand how cardiac fibrosis mediated by inflammatory microvascular disease evolves during advanced chronic kidney disease and end stage renal failure and importantly how this changes with commencement on renal replacement therapy (haemodialysis and peritoneal dialysis) using sequential cardiac MRI imaging. This method of imaging is non-invasive, provides significantly more data than echocardiography, is reproducible and accurate, has been validated in numerous studies and does not involve exposure to ionising radiation. Secondly, this study aims to examine the changes in monocyte subsets and biochemical profile in peripheral blood prior to, during and after commencement on renal replacement therapy. The investigators hypothesis would be that renal failure causes alteration in monocyte subset phenotype resulting in increased circulating inflammatory monocytes (human CD14high CD16high), initiating pro-inflammatory cytokine expression and thereby accelerating inflammatory cardiovascular disease and development of myocardial fibrosis.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 1, 2021 |
Est. primary completion date | February 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients with a diagnosis of Chronic Kidney Disease stage 4 and above 2. Patients with a progressive decline in renal function with a expectation to require future renal replacement therapy or currently on renal replacement therapy (Haemodialysis or Peritoneal Dialysis) 3. Exclusion of macrovascular cardiac disease within the last 3 years 4. Access for haemodialysis planned via tunnelled central venous catheter Exclusion Criteria: 1. Age under eighteen 2. Patients with a diagnosis of Diabetes Mellitus 3. Untreated macrovascular cardiac disease or Acute Coronary syndrome within 6 months of recruitment 4. Previous or current treatment with immunosuppressive/modulatory therapy 5. Current Malignancy 6. Current use of Metformin 7. Pregnancy 8. Contraindication to MRI Imaging 9. Patients lacking capacity or unable to consent and non-English language speakers 10. Immediate modality switch after commencement on renal replacement therapy i.e. transplantation 11. Plan for treatment centre change/move outside of Imperial College Healthcare NHS Trust following commencement on renal replacement therapy 12. Patients currently participating in an active CTIMP trial |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College Healthcare NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Imperial College Healthcare NHS Trust, National Institute for Health Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The development and modulation of myocardial fibrosis and change in cardiac function with CKD progression and commencement on renal replacement therapy | Cardiac MRI assessment of the evolution of myocardial fibrosis and cardiac function using sequential contrast enhanced CMR imaging (at three time points) during transition to end stage renal failure and commencement on renal replacement therapy | 18 Months | |
Secondary | Change in monocyte subsets and biochemical profile in peripheral blood with CKD progression and commencement on renal replacement therapy | Assessment of change in monocyte subset (phenotype and function), plasma cytokine levels and lipid profile in sequential blood samples collected during transition from advanced CKD to commencement on renal replacement therapy correlated with myocardial fibrosis and cardiovascular risk. | 18 Months |
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