Clinical trial NCT04510792: IMpact of HyPeRkalaemia on ThErapy with Renin AngiotenSin AldoSterone System Inhibitors
Official title: IMpact of HyPeRkalaemia on ThErapy with Renin AngiotenSin AldoSterone System Inhibitors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hyperkalemia
Keywords: Hyperkalemia due to RAASi
RAASi
Hyperkalaemia
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Vifor Pharma
First posted: 2020-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients or ED attenders receiving RAASi and with an episode of hyperkalaemia (potassium ≥5.5 mmol/l)

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?

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients who take RAASi for clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.
timeFrame: 12 months
measure: Proportion of patients who take RAASi without clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia.
timeFrame: 12 months
Secondary outcomes:
measure: Recurrent hyperkalaemias.
timeFrame: 12 months
measure: Proportion of patients continuing of RAASi.
timeFrame: 3 months and 12 months
measure: Hospitalisations
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Level of hyperkalaemia leading to changes to RAASi.
timeFrame: 12 months
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
state: Hampshire
Study officials:
affiliation: Portsmouth Hospitals University NHS Trust
name: Paul R Kalra, Professor
role: PRINCIPAL_INVESTIGATOR
References: