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Stopped: withdrawn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 range18 Years

SexALL

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

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 range18 Years

SexALL

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