IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors (IMPRESS)

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperkalemia
• Intervention / Treatment: Other: No intervention

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?

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Recruiting
      • Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
      • Contact: Anna Cunnigton, Ms
      • Principal Investigator: Paul Kalra, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number and causes (all cause, cardiovascular or HF) of mortality at 12 months.	12 months
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.	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.	3 months and 12 months
Hospitalisations	Number and causes (all cause, cardiovascular or HF) of hospitalisations at 12 months	12 months
Level of hyperkalaemia leading to changes to RAASi.	Level of hyperkalaemia at which healthcare professionals reduce dose/stop RAASi.	12 months

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Collaborators: Vifor Pharma

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Anticipated): August 12, 2024
• Study Completion (Anticipated): August 12, 2024

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hyperkalaemia; RAASi; Hyperkalemia due to RAASi
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyperkalemia
• Other Study ID Numbers: PHT/2020/60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No