LOKELMA Arterial Stiffness Study

• Research type

  Research Study

• Full title

  Effect of Lokelma on Arterial Stiffness in patients with type 2 diabetes and CKD on renin angiotensin system inhibition

• IRAS ID

  1003236

• Contact name

  Janaka Karalliedde

• Sponsor organisation

  King's College London

• Eudract number

  2020-000093-24

• Research summary

  People with diabetes and kidney disease are at high risk of heart disease and damage to their blood vessels. There is evidence that raised levels of a hormone called aldosterone, that affects salt and water balance, and acts in the kidney may increase this risk. Increased levels of aldosterone result in faster ageing of large blood vessels and this is associated with increased risk of heart and kidney disease.
  The ageing of large blood vessels can be measured by a non-invasive bed side test called aortic pulse wave velocity (Ao-PWV) which can predict risk of heart and kidney disease.
  Treatments that can lower aldosterone provide heart and kidney benefits.
  In recent studies, treatment with Lokelma (a medication that is used to prevent increased levels of pottasium in the blood) reduced aldosterone levels, blood pressure and albuminuria (a marker of damage of blood vessels).
  It is currently unclear if the observed reductions in aldosterone and blood pressure provide protective benefits to the blood vessels and the heart in people with diabetes and kidney disease.
  We hypothesize that Lokelma will reduce arterial ageing (as measured by Ao-PWV) in patients with T2DM and kidney disease by reducing aldosterone levels.
  This study aims to investigate if Lokelma treatment for 12 weeks has benefits for the health of blood vessels and the heart in people with diabetes and kidney disease.
  As this is a cross over study all participants will receive Lokelma treatment and attend for a total of 7 visits over the 26 week duration of the study to have measurements of the health and ageing of their blood vessels and markers of salt and water balance and kidney function evaluated.
  This work would lead to a larger study with longer follow up to confirm if Lokelma can help to reduce heart and kidney disease.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  21/LO/0315

• Date of REC Opinion

  16 Jun 2021

• REC opinion

  Further Information Favourable Opinion