Estimating the prevalence of hyperkalemia in the UK, in patients with chronic kidney disease and/or heart failure

Study type
Protocol
Date of Approval
Study reference ID
17_034
Lay Summary

Hyperkalemia refers to an increased level of potassium in the blood, which can occur when the body produces too much potassium, or when the body cannot get rid of existing potassium very effectively. Some of the patients at highest risk of developing hyperkalemia are those taking medications that raise their potassium levels as a side effect. These medications are used to treat high blood pressure, a common condition found alongside chronic kidney disease (CKD) and heart failure (HF). When the hormone system that controls blood pressure is abnormally active, blood pressure rises. Inhibitors of this system, medications called renin-angiotensin-aldosterone system inhibitors (RAASi), work to interrupt this system, thereby reducing blood pressure. However, RAASi therapies can also increase blood potassium levels by causing the retention of potassium in the blood, leading to serious incidents involving the heart. Over the long term, patients with CKD and HF are at high risk for hyperkalemia if they continue taking RAASi therapy. Understanding how many people who have had CKD and/or HF and have also had hyperkalemia, and the treatment implications following a hyperkalemic event are necessary to demonstrate the considerable unmet need for a treatment that is able to control hyperkalemia over the long term in this patient group.

Technical Summary

Hyperkalemia is medically defined as a blood serum potassium level of > 5.5mmol/L, which can arise from ineffective elimination of potassium from the blood. Hyperkalemia is common in patients with CKD and HF as the kidneys are unable to sufficiently remove excess potassium from the blood. RAAS inhibitors are indicated for the treatment of CKD and HF as they lower resistance in the blood vessels of the kidneys through inhibition of key enzymes controlling the RAAS system. A side effect of this inhibition is the retention of potassium, which may lead to hyperkalemia in high-risk patients, meaning that patients on RAASis may be undertreated. The purpose of this study is to gain an understanding of the prevalence of hyperkalemia among patients with CKD, HF, or both CKD and HF, and to determine clinical decisions after a hyperkalemia event in these groups specifically in relation to treatment with renin-angiotensin-aldosterone system inhibitor (RAASi) therapy. This research will be important in understanding the unmet need in this patient group for a hyperkalemia treatment which safely controls the condition over the long term. Currently, long term hyperkalemia treatment options are limited in the CKD/HF patient population who are also taking RAASis.

Health Outcomes to be Measured

Prevalence of hyperkalemia; Renin-angiotensin aldosterone- system inhibitor treatment patterns.

Collaborators

Mireia Raluy Callado - Chief Investigator - Evidera, Inc
Mireia Raluy Callado - Corresponding Applicant - Evidera, Inc
Alex Simpson - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Laura McDonald - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Robert Donaldson - Collaborator - Evidera Ltd - UK
Vrouchou Panagiota - Collaborator - Vifor Pharma