Hyperkalaemia and Its Impact on Therapy with RAASi
- Conditions
- HyperkalaemiaHeart Failure with Reduced Ejection FractionLeft Ventricular Systolic Dysfunction
- Registration Number
- NCT04249648
- Lead Sponsor
- Portsmouth Hospitals NHS Trust
- 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)?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 651
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of hyperkalaemia in patients with new diagnosis of HFrEF 12 months Incidence of hyperkalaemia in patients with new heart failure with reduced ejection fraction started on renin-angiotensin-aldosterone receptor inhibitor(s)
Proportion of patients with hyperkalaemia (hospitalised or attending ED) who experienced changes to RAASi after episodes of hyperkalaemia 12 months 3. Proportion of hospitalised patients/ED attenders with documented hyperkalaemia, receiving RAASi for prognostic benefit who experience RAASi dose reduction/withdrawal, assessed at discharge
Frequency of dose reduction/withdrawal for RAASi after hyperkalaemia in patients with HFrEF 12 months Proportion of patients with new HFrEF started on RAASi who experienced RAASi dose reduction/withdrawal/prevention of dose uptitration due to hyperkalaemia.
- Secondary Outcome Measures
Name Time Method RAASi discontinuation due to other causes rather than hyperkalaemia 12 months Proportion of patients discontinuing RAASi due to other causes than hyperkalaemia (hypotension, worsening renal function, other).
Mortality 12 months Number and causes (all cause, cardiovascular or HF) of mortality at 12 months.
Hospitalisations 12 months Number and causes (all cause, cardiovascular or HF) of hospitalisation at 12 months.
Description of healthcare professionals making changes to RAASi after episodes of hyperkalaemia 12 months Proportion of different grades and specialties of healthcare professionals reducing dose/stopping RAASi in hyperkalaemic patients.
Awareness of RAASi benefits and target doses for patients with HFrEF 12 months Proportion of different grades and specialties of healthcare professionals who are aware of RAASi target doses and benefits in HFrEF.
Hyperkalaemia level at which healthcare professionals make changes to RAASi 12 months Level of hyperkalaemia at which healthcare professionals reduce/stop RAASi in patients with and without clear prognostic indications for RAASi.
Incidence of repeated episodes of hyperkalaemia 12 months Incidence of repeated episodes of hyperkalaemia after initial episode.
Trial Locations
- Locations (1)
Portsmouth Hospitals University NHS Trust
🇬🇧Portsmouth, United Kingdom