Hyperkalaemia and Its Impact on Therapy with RAASi

NCT ID: NCT04249648

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 651 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2024-11-01

Brief 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.

Detailed 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)?

Conditions

Hyperkalaemia; Heart Failure with Reduced Ejection Fraction; Left Ventricular Systolic Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with new diagnosis of heart failure with reduced ejection fraction

Patients with new diagnosis of heart failure with reduced ejection fraction who will be started on renin-angiotensin-aldosterone system inhibitors or in whom there is a plan to increase renin-angiotensin-aldosterone system inhibitors (if already taking prior to diagnosis of heart failure).

No interventions assigned to this group

Patients with hyperkalaemia

Hospitalised patients and patients attending emergency department who have at least 1 blood test with a potassium level of ≥5.5 mmol/l.

No interventions assigned to this group

Healthcare professionals managing patients with hyperkalaemia

Healthcare professionals (doctors, pharmacists, non-medical prescribers) who manage patients with hyperkalaemia and/or heart failure and hyperkalaemia.

No interventions assigned to this group

Eligibility Criteria

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.

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.

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

For patients with hyperkalaemia

For healthcare professionals:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vifor Pharma

INDUSTRY

Sponsor Role: collaborator

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul R Kalra, Professor

Role: PRINCIPAL_INVESTIGATOR

Queen Alexandra Hospital, Portsmouth, UK

Locations

Portsmouth Hospitals University NHS Trust

Portsmouth, , United Kingdom

Countries

United Kingdom

Other Identifiers

PHT/2020/11

Identifier Type: -

Identifier Source: org_study_id