WithdrawnNot Applicable

IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors

Stopped: withdrawn

United Kingdom0Started 2021-07-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients who take RAASi for clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.

Timeframe: 12 months

Proportion of patients who take RAASi without clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.

Timeframe: 12 months

Trial details

NCT IDNCT04510792

SponsorPortsmouth Hospitals NHS Trust

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2021-07-12

View on ClinicalTrials.gov More Hyperkalemia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

What they're measuring

Proportion of patients who take RAASi for clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.

Timeframe: 12 months

Proportion of patients who take RAASi without clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.

Timeframe: 12 months