IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors

NCT04510792 | Withdrawn

• 1 other identifier: PHT/2020/60
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperkalemia

Keywords

Hyperkalemia due to RAASi; RAASi; Hyperkalaemia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Secondary Outcomes (5)

• Recurrent hyperkalaemias.

  12 months

• Proportion of patients continuing of RAASi.

  3 months and 12 months

• Hospitalisations

  12 months

• Mortality

  12 months

• Level of hyperkalaemia leading to changes to RAASi.

  12 months

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• Vifor Pharma: collaborator

Study Sites (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Paul R Kalra, Professor

  Portsmouth Hospitals University NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: July 12, 2021
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)