A multi-centre, retrospective real world study on the use of renin-angiotensin-aldosterone system inhibitors (RAASi) management in patients treated for chronic kidney disease alongside heart failure and/or type 2 diabetes mellitus. (SoMoR – UK (Study of Management of RAASi in UK))

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Sentinel sites, Retrospective, observational

Study drug and medical condition

• Medical condition to be studied:
  Chronic kidney disease

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  To describe prescribing modalities of RAASi in patients with CKD + either Heart Failure (HF) and/or Type 2 Diabetes Mellitus in the UK NHS setting.
• Outcomes:
  Mean maximum tolerated daily dose of RAASi achieved (as percentage of target dose). Length of time on maximum tolerated daily dose of RAASiProportion of patients with HF who receive RAASi and MRALength of time on maximum tolerated daily dose of MRAProportion of patients with elevated serum potassium level (>5.1 mmol/L, >5.5 mmol/L or >6.0 mmol/L) Change in mean serum potassium, creatinine, urine protein and BP level over the observation period
• Data analysis plan:
  The analyses will be descriptive and therefore the required sample size will be estimated based on precision instead of statistical power. A sample size estimate will be confirmed during protocol development but it is expected that approximately 100 patients will be sufficient to generate reliable results, as determined by relatively narrow confidence intervals.Data from all centres will be pooled for analysis. Categorical data will be described by the number (n) and percentage (%) of patients in each category. Continuous data will be described by number of observations, mean and standard deviation (SD) for normally distributed data or median and interquartile range for non-normally distributed data, and minimum and maximum values where relevant. Missing and invalid observations will be tabulated as a separate category. Rates will be reported with 95% CIs.