IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors

Hyperkalemia Clinical Trial

— IMPRESS  

Official title:

IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04510792
• Other study ID #: PHT/2020/60
• Status: Recruiting
• Start date: July 12, 2021
• Est. completion date: August 12, 2024

Study information

• Verified date: April 2023
• Source: Portsmouth Hospitals NHS Trust
• Contact: Elena Cowan, PhD
• Phone: 02392 286000
• Email: elena.cowan[@]porthosp.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 12, 2024
• Est. primary completion date: August 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients in ED or inpatients with at least 1 blood test with a potassium level of =5.5 mmol/l

2. Receiving RAASi.

3. Aged 18 and above.

4. Able to provide informed consent or consent provided by consultee in those unable to consent for themselves.

Exclusion Criteria:

1. Patients already receiving dialysis prior to the episode of hyperkalaemia.

2. For patients considered for postal consent: known cognitive impairment, learning difficulties or brain injury or those who had transient cognitive impairment, delirium or required urgent deprivation of liberty form completion during inpatient stay or in the previous 12 months prior to hyperkalaemia episode.

Related Conditions & MeSH terms

• Hyperkalemia

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital	Portsmouth	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust	Vifor Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who take RAASi for clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.	Proportion of hospitalised patients/ED attenders receiving RAASi for clear prognostic indication who experience RAASi dose reduction/withdrawal due to hyperkalaemia at discharge.	12 months
Primary	Proportion of patients who take RAASi without clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.	Proportion of hospitalised patients/ED attenders receiving RAASi without clear prognostic indication who experience RAASi dose reduction/withdrawal due to hyperkalaemia at discharge.	12 months
Secondary	Recurrent hyperkalaemias.	Number of repeated episodes of hyperkalaemia after initial episode according to laboratory reports (episodes can be as inpatient or outpatient) captured during study period.	12 months
Secondary	Proportion of patients continuing of RAASi.	Proportion of patients continuing of RAASi therapy after initial episodes of hyperkalaemia at 3 months and 12 months.	3 months and 12 months
Secondary	Hospitalisations	Number and causes (all cause, cardiovascular or HF) of hospitalisations at 12 months	12 months
Secondary	Mortality	Number and causes (all cause, cardiovascular or HF) of mortality at 12 months.	12 months
Secondary	Level of hyperkalaemia leading to changes to RAASi.	Level of hyperkalaemia at which healthcare professionals reduce dose/stop RAASi.	12 months