HyperkalemiaIMPRESSNCT04510792
IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors
An observational study of Hyperkalemia, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jul 2021to 12 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients or ED attenders receiving RAASi and with an episode of hyperkalaemia (potassium ≥5.5 mmol/l)
Who may be able to join
- Patients in ED or inpatients with at least 1 blood test with a potassium level of ≥5.5 mmol/l
- Receiving RAASi.
- Aged 18 and above.
- Able to provide informed consent or consent provided by consultee in those unable to consent for themselves.
Who cannot join
- Patients already receiving dialysis prior to the episode of hyperkalaemia.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
About this study
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:
- How does hyperkalaemia impact on RAASi therapy and does this vary according to the clinical indication for the drug(s)?
- What are the demographics, co-morbidities and drug history for patients presenting with hyperkalaemia?
- What is the frequency of subsequent hospitalisations and mortality rate in a cohort of patients presenting with hyperkalaemia at 12 months?
- Conditions
- Hyperkalemia
- Being tested
- No intervention
- Keywords
- Hyperkalemia due to RAASi, RAASi, Hyperkalaemia
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 12 months
Proportion of patients continuing of RAASi.
Proportion of patients continuing of RAASi therapy after initial episodes of hyperkalaemia at 3 months and 12 months.
Measured: 3 months and 12 months
Hospitalisations
Number and causes (all cause, cardiovascular or HF) of hospitalisations at 12 months
Measured: 12 months
Mortality
Number and causes (all cause, cardiovascular or HF) of mortality at 12 months.
Measured: 12 months
Level of hyperkalaemia leading to changes to RAASi.
Level of hyperkalaemia at which healthcare professionals reduce dose/stop RAASi.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start12 Jul 2021
- Primary completion12 Jul 2021
- Study completion12 Jul 2021
Why it stopped: withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor
- Investigators
- Paul R Kalra, Professor, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510792
- Sponsor's protocol ID
- PHT/2020/60
- Acronym
- IMPRESS
- Status last verified
- Dec 2025
- First submitted
- 10 Aug 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors
- ClinicalTrials.gov ID
- NCT04510792
- Acronym / sponsor ID
- IMPRESS / PHT/2020/60
- Conditions
- Hyperkalemia
- Keywords
- Hyperkalemia due to RAASi, RAASi, Hyperkalaemia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- Vifor Pharma
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How does hyperkalaemia impact on RAASi therapy and does this vary according to the clinical indication for the drug(s)?
- What are the demographics, co-morbidities and drug history for patients presenting with hyperkalaemia?
- What is the frequency of subsequent hospitalisations and mortality rate in a cohort of patients presenting with hyperkalaemia at 12 months?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients or ED attenders receiving RAASi and with an episode of hyperkalaemia (potassium ≥5.5 mmol/l)
Key inclusion criteria (4 listed)
- Patients in ED or inpatients with at least 1 blood test with a potassium level of ≥5.5 mmol/l
- Receiving RAASi.
- Aged 18 and above.
- Able to provide informed consent or consent provided by consultee in those unable to consent for themselves.
Key exclusion criteria (2 listed)
- Patients already receiving dialysis prior to the episode of hyperkalaemia.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Proportion of patients who take RAASi for clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.
Time frame: 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.
Proportion of patients who take RAASi without clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.
Time frame: 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.
5 secondary outcomes
Recurrent hyperkalaemias.
Time frame: 12 months
Proportion of patients continuing of RAASi.
Time frame: 3 months and 12 months
Hospitalisations
Time frame: 12 months
Mortality
Time frame: 12 months
Level of hyperkalaemia leading to changes to RAASi.
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul R Kalra, Professor principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkalemia, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who take RAASi for clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.