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withdrawn
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| Name | Class |
|---|---|
| Vifor Pharma | INDUSTRY |
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There are limited data regarding the burden of hyperkalaemia in patients attending emergency departments (ED) or who are hospitalised (excluding those already receiving dialysis). Renin-angiotensin-aldosterone system inhibitors (RAASi) are of prognostic benefit in patients with heart failure with reduced ejection fraction (HFrEF) and post myocardial infarction (MI) left ventricular systolic dysfunction (LVSD) and as such should be continued wherever possible for these indications. These drugs may contribute to elevation in serum potassium and hyperkalaemia may lead to a reduction in dose or complete withdrawal of RAASi. Yet it remains unknown how common this happens in standard clinical practice. Inappropriate discontinuation of RAASi in such patients may lead to adverse clinical outcomes. If patients have hyperkalaemia that limits the use of RAASi, they may be candidates for new potassium binders that could facilitate their continued use.
Research questions:
In an adult population of patients who are hospitalised or attending the emergency department (and not receiving dialysis) with hyperkalaemia:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who take RAASi for clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia. | Proportion of hospitalised patients/ED attenders receiving RAASi for clear prognostic indication who experience RAASi dose reduction/withdrawal due to hyperkalaemia at discharge. | 12 months |
| Proportion of patients who take RAASi without clear prognostic indications and who had changes to RAASi as a result of hyperkalaemia. | Proportion of hospitalised patients/ED attenders receiving RAASi without clear prognostic indication who experience RAASi dose reduction/withdrawal due to hyperkalaemia at discharge. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent hyperkalaemias. | Number of repeated episodes of hyperkalaemia after initial episode according to laboratory reports (episodes can be as inpatient or outpatient) captured during study period. | 12 months |
| Proportion of patients continuing of RAASi. |
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Inclusion Criteria:
Exclusion Criteria:
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Inpatients or ED attenders receiving RAASi and with an episode of hyperkalaemia (potassium ≥5.5 mmol/l)
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| Name | Affiliation | Role |
|---|---|---|
| Paul R Kalra, Professor | Portsmouth Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital | Portsmouth | Hampshire | PO6 3LY | United Kingdom |
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| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Proportion of patients continuing of RAASi therapy after initial episodes of hyperkalaemia at 3 months and 12 months. |
| 3 months and 12 months |
| Hospitalisations | Number and causes (all cause, cardiovascular or HF) of hospitalisations at 12 months | 12 months |
| Mortality | Number and causes (all cause, cardiovascular or HF) of mortality at 12 months. | 12 months |
| Level of hyperkalaemia leading to changes to RAASi. | Level of hyperkalaemia at which healthcare professionals reduce dose/stop RAASi. | 12 months |