Hyperkalaemia and Its Impact on Therapy With RAASi

Heart Failure With Reduced Ejection Fraction Clinical Trial

— REVIEW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04249648
• Other study ID #: PHT/2020/11
• Status: Recruiting
• Start date: July 12, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: November 2022
• Source: Portsmouth Hospitals NHS Trust
• Contact: Sarah M Birkhoelzer, Dr
• Phone: +44 02392 286000
• Email: sarah.birkhoelzer[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The study aims to answer the following research questions:

1. 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?

2. How does it impact on RAASi prescription?

3. 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?

4. 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)?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For patients with heart failure

Inclusion criteria

1. 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).

2. Able to provide informed consent.

3. Age 18 and above.

Exclusion criteria: 1. Patients receiving dialysis.

For patients with hyperkalaemia

Inclusion criteria

1. 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.

2. Able to provide informed consent.

3. Age 18 and above.

Exclusion criteria: 1. Patients receiving dialysis.

For healthcare professionals:

Inclusion criteria

1. Doctors, pharmacists, non-medical prescribers working at primary and secondary care.

2. Able to provide informed consent.

3. 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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Hyperkalaemia
• Hyperkalemia
• Left Ventricular Systolic Dysfunction
• Systolic Murmurs
• Ventricular Dysfunction, Left

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals University NHS Trust	Portsmouth

Sponsors (2)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust	Vifor Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hyperkalaemia in patients with new diagnosis of HFrEF	Incidence of hyperkalaemia in patients with new heart failure with reduced ejection fraction started on renin-angiotensin-aldosterone receptor inhibitor(s)	12 months
Primary	Frequency of dose reduction/withdrawal for RAASi after hyperkalaemia in patients with HFrEF	Proportion of patients with new HFrEF started on RAASi who experienced RAASi dose reduction/withdrawal/prevention of dose uptitration due to hyperkalaemia.	12 months
Primary	Proportion of patients with hyperkalaemia (hospitalised or attending ED) who experienced changes to RAASi after episodes of hyperkalaemia	3. Proportion of hospitalised patients/ED attenders with documented hyperkalaemia, receiving RAASi for prognostic benefit who experience RAASi dose reduction/withdrawal, assessed at discharge	12 months
Secondary	Incidence of repeated episodes of hyperkalaemia	Incidence of repeated episodes of hyperkalaemia after initial episode.	12 months
Secondary	RAASi discontinuation due to other causes rather than hyperkalaemia	Proportion of patients discontinuing RAASi due to other causes than hyperkalaemia (hypotension, worsening renal function, other).	12 months
Secondary	Mortality	Number and causes (all cause, cardiovascular or HF) of mortality at 12 months.	12 months
Secondary	Hospitalisations	Number and causes (all cause, cardiovascular or HF) of hospitalisation at 12 months.	12 months
Secondary	Hyperkalaemia level at which healthcare professionals make changes to RAASi	Level of hyperkalaemia at which healthcare professionals reduce/stop RAASi in patients with and without clear prognostic indications for RAASi.	12 months
Secondary	Description of healthcare professionals making changes to RAASi after episodes of hyperkalaemia	Proportion of different grades and specialties of healthcare professionals reducing dose/stopping RAASi in hyperkalaemic patients.	12 months
Secondary	Awareness of RAASi benefits and target doses for patients with HFrEF	Proportion of different grades and specialties of healthcare professionals who are aware of RAASi target doses and benefits in HFrEF.	12 months