Hyperkalaemia and Its Impact on Therapy with RAASi

NCT04249648 | Completed

• 1 other identifier: PHT/2020/11
• Study Type: observational
• Target: 651
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hyperkalaemia; Heart failure with reduced ejection fraction; Renin-angiotensin-aldosterone system inhibitors; Left Ventricular Systolic Dysfunction; Decision making process; Hyperkalaemia due to RAASi

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• Incidence of repeated episodes of hyperkalaemia

  12 months

• RAASi discontinuation due to other causes rather than hyperkalaemia

  12 months

• Mortality

  12 months

• Hospitalisations

  12 months

• Hyperkalaemia level at which healthcare professionals make changes to RAASi

  12 months

Study Arms (3)

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).

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.

Healthcare professionals managing patients with hyperkalaemia

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

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

Newly diagnosed heart failure with reduced ejection fraction (within 4 weeks of diagnosis, including those with post myocardial infarction left-ventricular systolic dysfunction) 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 and not receiving dialysis prior to the episode of hyperkalaemia. Healthcare professionals managing patients with hyperkalaemia and/or heart failure

You may qualify if:

• 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.

You may not qualify if:

• For patients with hyperkalaemia
• 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.
• For healthcare professionals:
• Doctors, pharmacists, non-medical prescribers working at primary and secondary care.
• Able to provide informed consent.
• Age 18 and above.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Portsmouth Hospitals University NHS Trust

Portsmouth, United Kingdom

Location

MeSH Terms

Conditions

Hyperkalemia; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Paul R Kalra, Professor

  Queen Alexandra Hospital, Portsmouth, UK

  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: January 29, 2020
• First Posted: January 31, 2020
• Study Start: July 12, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)