NCT04249648

Hyperkalaemia and Its Impact on Therapy with RAASi

BuRden of Hyperkalaemia and EValuatIon of ChangEs to Therapy with Renin-angiotensin-aldosterone System Inhibitors Following Episodes of Elevated Potassium

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 651 (actual)
• Sponsor: Portsmouth Hospitals NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Renin-angiotensin-aldosterone system inhibitors (RAASi) have transformed prognosis of patients with heart failure with reduced ejection fraction, diabetic nephropathy and chronic kidney disease. However, in everyday clinical practice patients often receive suboptimal doses of RAASi. The development of hyperkalaemia is one of the reasons for dose reduction or complete withdrawal of RAASi and this in turn is likely to have an adverse impact on patient outcomes. Yet it remains unknown precisely how often hyperkalaemia leads to changes to RAASi doses, if it is the sole reason, or whether this occurs in combination with other clinical situations such as worsened renal function and hypotension. It is also unclear what influences the decision-making process of healthcare professionals in managing patients with hyperkalaemia who take RAASi and if this is influenced by specialty, experience or indications for RAASi. In order to improve our understanding of the problem we are taking forward a research study (made up of 3 complimentary studies). These data are needed to help achieve our ultimate goal of improving the care of patients with prognostic indication for RAASi.

Detailed description

The study aims to answer the following research questions: 1. What is the incidence of hyperkalaemia following RAASi therapy initiation and uptitration in patients with a new diagnosis of HFrEF including those with a new diagnosis of post myocardial infarction (MI) left ventricular systolic dysfunction? 2. How does it impact on RAASi prescription? 3. How does hyperkalaemia impact on RAASi therapy according to the clinical indication for the drug(s) in an adult population of patients who are hospitalised or attending the emergency department (and not receiving dialysis) with hyperkalaemia and receiving RAASi? 4. At what level of hyperkalaemia do healthcare professionals consider making changes to RAASi and does it vary according to the clinical indication for the drug(s)?

Conditions

• Hyperkalaemia
• Heart Failure with Reduced Ejection Fraction
• Left Ventricular Systolic Dysfunction

Timeline

• Start date: 2021-07-12
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2020-01-31
• Last updated: 2024-11-14

Locations

1 site across 1 country: United Kingdom