Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-26 @ 8:42 AM
Study NCT ID:
NCT04510792
Status:
WITHDRAWN
Last Update Posted:
2025-12-23
First Post:
2020-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors
Sponsor:
Portsmouth Hospitals NHS Trust
Organization:
Study Overview
Official Title:
IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors
Status:
WITHDRAWN
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPRESS
Brief Summary:
There are limited data regarding the burden of hyperkalaemia in patients attending emergency departments (ED) or who are hospitalised (excluding those already receiving dialysis). Renin-angiotensin-aldosterone system inhibitors (RAASi) are of prognostic benefit in patients with heart failure with reduced ejection fraction (HFrEF) and post myocardial infarction (MI) left ventricular systolic dysfunction (LVSD) and as such should be continued wherever possible for these indications. These drugs may contribute to elevation in serum potassium and hyperkalaemia may lead to a reduction in dose or complete withdrawal of RAASi. Yet it remains unknown how common this happens in standard clinical practice. Inappropriate discontinuation of RAASi in such patients may lead to adverse clinical outcomes. If patients have hyperkalaemia that limits the use of RAASi, they may be candidates for new potassium binders that could facilitate their continued use.
Detailed Description:
Research questions:
In an adult population of patients who are hospitalised or attending the emergency department (and not receiving dialysis) with hyperkalaemia:
1. How does hyperkalaemia impact on RAASi therapy and does this vary according to the clinical indication for the drug(s)?
2. What are the demographics, co-morbidities and drug history for patients presenting with hyperkalaemia?
3. What is the frequency of subsequent hospitalisations and mortality rate in a cohort of patients presenting with hyperkalaemia at 12 months?
In an adult population of patients who are hospitalised or attending the emergency department (and not receiving dialysis) with hyperkalaemia:
1. How does hyperkalaemia impact on RAASi therapy and does this vary according to the clinical indication for the drug(s)?
2. What are the demographics, co-morbidities and drug history for patients presenting with hyperkalaemia?
3. What is the frequency of subsequent hospitalisations and mortality rate in a cohort of patients presenting with hyperkalaemia at 12 months?
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: