SoMoR – UK (Study of Management of RAASi in UK)

  • Research type

    Research Study

  • Full title

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

  • IRAS ID

    238554

  • Contact name

    Lisa Moore-Ramdin

  • Contact email

    lisa.moore-ramdin@viforpharma.com

  • Sponsor organisation

    Vifor Fresenius Medical Care Renal Pharma UK Ltd.

  • Duration of Study in the UK

    0 years, 8 months, days

  • Research summary

    It is estimated that approximately 6% of the population of England aged 16 years or older have chronic kidney disease (CKD) stage 3 to 5. Renin–angiotensin–aldosterone system inhibitors (RAASi) are often prescribed to patients with CKD, with or without heart failure (HF) and with or without diabetes mellitus (T2DM) to prevent the disease getting worse.

    Patients who take RAASi medication are at risk of having high potassium levels which, if untreated, can be life threatening. An added risk to patients with HF who take RAASi, are medicines these patients take to ease the symptoms of HF. Like RAASi, these medicines can heighten the levels of potassium. Because of the impact of RAASi and HF drugs on potassium levels, patients who suffer from CKD and HF are often prescribed lower than necessary doses of these two types of medication. To increase an understanding about how RAASi drugs are prescribed in patients with CKD and/or HF and/or T2DM, we would like to carry out a retrospective observational study. Medical records of patients with this diagnosis and who were never able to take the best possible dose of RAASi recommended for them will be reviewed.
    The main focus of this study is to describe the way clinicians manage the dosing of RAASi in patients with CKD and HF and/or T2DM. Secondly, we want to describe the dosing of HF medicines prescribed to control HF symptoms in patients with CKD and HF taking RAASi. We will also look at other medicines these patients take whilst on RAASi medication. Lastly, we will describe the characteristics of the patients who do not achieve the dose of RAASi that would be recommended to them.
    All the study data will be obtained in anonymised-coded form from the hospital medical records of approx 100 eligible patients.

  • REC name

    West Midlands - Coventry & Warwickshire Research Ethics Committee

  • REC reference

    18/WM/0009

  • Date of REC Opinion

    19 Jan 2018

  • REC opinion

    Further Information Favourable Opinion