NCT04249648Completed
Hyperkalaemia and Its Impact on Therapy with RAASi
BuRden of Hyperkalaemia and EValuatIon of ChangEs to Therapy with Renin-angiotensin-aldosterone System Inhibitors Following Episodes of Elevated Potassium
Source: ClinicalTrials.gov · Last updated 14 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 651 (actual)
- First submitted
- 29 Jan 2020
- Start date
- 12 Jul 2021
- Primary completion date
- 1 Nov 2024
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Diseases
- Heart failure
- NCT number
- NCT04249648
What you commit to
- Study type: Observational
- Participants enrolled: 651
- From 12 Jul 2021 to the primary completion date, 1 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- For patients with hyperkalaemia
- For healthcare professionals:
Who the study is looking for
- 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.
- 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.
- Doctors, pharmacists, non-medical prescribers working at primary and secondary care.
- Able to provide informed consent.
- Age 18 and above.
Criteria the registry did not label
- For patients with heart failure
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Portsmouth Hospitals University NHS Trust Coordinator of this site? Confirm its status | Portsmouth | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.