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NCT Number: NCT04249648

Hyperkalaemia and Its Impact on Therapy with RAASi

Renin-angiotensin-aldosterone system inhibitors (RAASi) have transformed prognosis of patients with heart failure with reduced ejection fraction, diabetic nephropathy and chronic kidney disease. However, in everyday clinical practice patients often receive suboptimal doses of RAASi. The development of hyperkalaemia is one of the reasons for dose reduction or complete withdrawal of RAASi and this in turn is likely to have an adverse impact on patient outcomes. Yet it remains unknown precisely how often hyperkalaemia leads to changes to RAASi doses, if it is the sole reason, or whether this occurs in combination with other clinical situations such as worsened renal function and hypotension. It is also unclear what influences the decision-making process of healthcare professionals in managing patients with hyperkalaemia who take RAASi and if this is influenced by specialty, experience or indications for RAASi.

In order to improve our understanding of the problem we are taking forward a research study (made up of 3 complimentary studies). These data are needed to help achieve our ultimate goal of improving the care of patients with prognostic indication for RAASi.

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Key information

Conditions

Hyperkalaemia Cardiovascular Diseases Heart Diseases Heart Failure With Reduced Ejection Fraction Hyperkalemia Left Ventricular Systolic Dysfunction Metabolic Diseases Nutritional and Metabolic Diseases Ventricular Dysfunction Ventricular Dysfunction, Left Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Portsmouth Hospitals University NHS Trust

Portsmouth, United Kingdom

About this study

The study aims to answer the following research questions:

  • What is the incidence of hyperkalaemia following RAASi therapy initiation and uptitration in patients with a new diagnosis of HFrEF including those with a new diagnosis of post myocardial infarction (MI) left ventricular systolic dysfunction?
  • How does it impact on RAASi prescription?
  • How does hyperkalaemia impact on RAASi therapy according to the clinical indication for the drug(s) in an adult population of patients who are hospitalised or attending the emergency department (and not receiving dialysis) with hyperkalaemia and receiving RAASi?
  • At what level of hyperkalaemia do healthcare professionals consider making changes to RAASi and does it vary according to the clinical indication for the drug(s)?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For patients with heart failure

Inclusion criteria

  • Patients with newly diagnosed HFrEF (within 4 weeks of diagnosis, including those with post MI LVSD, identified as outpatients or during hospital admission, typically for decompensated heart failure or post myocardial infarction) who are initiated on RAASi or have a clinical indication for uptitration of current RAASi (in patients already receiving RAASi for other indications).
  • Able to provide informed consent.
  • Age 18 and above.

Exclusion criteria

1. Patients receiving dialysis.

For patients with hyperkalaemia

Inclusion criteria

  • Patients in ED or inpatients who already receive RAASi and who have at least 1 blood test with a potassium level of ≥5.5 mmol/l.
  • Able to provide informed consent.
  • Age 18 and above.

Exclusion criteria

1. Patients receiving dialysis.

For healthcare professionals:

Inclusion criteria

  • Doctors, pharmacists, non-medical prescribers working at primary and secondary care.
  • Able to provide informed consent.
  • Age 18 and above.

Exclusion criteria

1. None

As this is an observational study, patients in other research studies or receiving any specific treatments for hyperkalaemia (other than chronic dialysis) will not be excluded. After consent, patients will also be permitted to participate in other research studies should they so wish. Patients with covid-19 can also be included.

Treatment and study plan

Primary outcomes

  1. Incidence of hyperkalaemia in patients with new diagnosis of HFrEF

    Time frame: 12 months

    Incidence of hyperkalaemia in patients with new heart failure with reduced ejection fraction started on renin-angiotensin-aldosterone receptor inhibitor(s)

  2. Frequency of dose reduction/withdrawal for RAASi after hyperkalaemia in patients with HFrEF

    Time frame: 12 months

    Proportion of patients with new HFrEF started on RAASi who experienced RAASi dose reduction/withdrawal/prevention of dose uptitration due to hyperkalaemia.

  3. Proportion of patients with hyperkalaemia (hospitalised or attending ED) who experienced changes to RAASi after episodes of hyperkalaemia

    Time frame: 12 months

    • Proportion of hospitalised patients/ED attenders with documented hyperkalaemia, receiving RAASi for prognostic benefit who experience RAASi dose reduction/withdrawal, assessed at discharge

Secondary outcomes

  1. Incidence of repeated episodes of hyperkalaemia

    Time frame: 12 months

    Incidence of repeated episodes of hyperkalaemia after initial episode.

  2. RAASi discontinuation due to other causes rather than hyperkalaemia

    Time frame: 12 months

    Proportion of patients discontinuing RAASi due to other causes than hyperkalaemia (hypotension, worsening renal function, other).

  3. Mortality

    Time frame: 12 months

    Number and causes (all cause, cardiovascular or HF) of mortality at 12 months.

  4. Hospitalisations

    Time frame: 12 months

    Number and causes (all cause, cardiovascular or HF) of hospitalisation at 12 months.

  5. Hyperkalaemia level at which healthcare professionals make changes to RAASi

    Time frame: 12 months

    Level of hyperkalaemia at which healthcare professionals reduce/stop RAASi in patients with and without clear prognostic indications for RAASi.

  6. Description of healthcare professionals making changes to RAASi after episodes of hyperkalaemia

    Time frame: 12 months

    Proportion of different grades and specialties of healthcare professionals reducing dose/stopping RAASi in hyperkalaemic patients.

  7. Awareness of RAASi benefits and target doses for patients with HFrEF

    Time frame: 12 months

    Proportion of different grades and specialties of healthcare professionals who are aware of RAASi target doses and benefits in HFrEF.

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Collaborators

  • Vifor Pharma

Registry information

Official study title

BuRden of Hyperkalaemia and EValuatIon of ChangEs to Therapy with Renin-angiotensin-aldosterone System Inhibitors Following Episodes of Elevated Potassium

Acronym: REVIEW

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2020
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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