IMpact of HyPeRkalaemia on ThErapy with Renin AngiotenSin AldoSterone System Inhibitors

Active, not recruiting

• Conditions: Hyperkalemia

• Registration Number: NCT04510792
• Lead Sponsor: Portsmouth Hospitals NHS Trust

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?

Study Timeline

• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Study Start: 2021-07-12
• Primary Completion: 2023-11-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients who take RAASi without clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.	12 months	Proportion of hospitalised patients/ED attenders receiving RAASi without clear prognostic indication who experience RAASi dose reduction/withdrawal due to hyperkalaemia at discharge.
Proportion of patients who take RAASi for clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.	12 months	Proportion of hospitalised patients/ED attenders receiving RAASi for clear prognostic indication who experience RAASi dose reduction/withdrawal due to hyperkalaemia at discharge.

Secondary Outcome Measures

Name	Time	Method
Hospitalisations	12 months	Number and causes (all cause, cardiovascular or HF) of hospitalisations at 12 months
Recurrent hyperkalaemias.	12 months	Number of repeated episodes of hyperkalaemia after initial episode according to laboratory reports (episodes can be as inpatient or outpatient) captured during study period.
Proportion of patients continuing of RAASi.	3 months and 12 months	Proportion of patients continuing of RAASi therapy after initial episodes of hyperkalaemia at 3 months and 12 months.
Mortality	12 months	Number and causes (all cause, cardiovascular or HF) of mortality at 12 months.
Level of hyperkalaemia leading to changes to RAASi.	12 months	Level of hyperkalaemia at which healthcare professionals reduce dose/stop RAASi.

Trial Locations

Locations (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital; 🇬🇧 Portsmouth, Hampshire, United Kingdom