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WithdrawnNCT04510792IMPRESSUpdated Dec 23, 2025

IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors

An observational study in Hyperkalemia, sponsored by Portsmouth Hospitals NHS Trust. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by Portsmouth Hospitals NHS Trust · Observational

Why this study was withdrawn
withdrawn
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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?
02

Conditions studied

  • Hyperkalemia

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Keywords

  • Hyperkalemia due to RAASi
  • RAASi
  • Hyperkalaemia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Inpatients or ED attenders receiving RAASi and with an episode of hyperkalaemia (potassium ≥5.5 mmol/l)

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • OtherNo intervention

    No intervention

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. Proportion of patients continuing of RAASi.

    Proportion of patients continuing of RAASi therapy after initial episodes of hyperkalaemia at 3 months and 12 months.

    Time frame: 3 months and 12 months

  3. Hospitalisations

    Number and causes (all cause, cardiovascular or HF) of hospitalisations at 12 months

    Time frame: 12 months

  4. Mortality

    Number and causes (all cause, cardiovascular or HF) of mortality at 12 months.

    Time frame: 12 months

  5. Level of hyperkalaemia leading to changes to RAASi.

    Level of hyperkalaemia at which healthcare professionals reduce dose/stop RAASi.

    Time frame: 12 months

06

Study locations

1 site
  • Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
    Portsmouth, Hampshire PO6 3LY, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04510792
Lead sponsor
Portsmouth Hospitals NHS Trust
Collaborators
Vifor Pharma
Responsible party
Sponsor
First posted
Aug 12, 2020
Start date
Jul 12, 2021
Primary completion
Jul 12, 2021
Completion
Jul 12, 2021
Last update
Dec 23, 2025

Study contacts

Paul R Kalra, Professor
principal investigator · Portsmouth Hospitals NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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