HyperkalaemiaREVIEWNCT04249648
Hyperkalaemia and Its Impact on Therapy with RAASi
An observational study of Hyperkalaemia and Heart Failure with Reduced Ejection Fraction, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalaemia, Heart Failure with Reduced Ejection Fraction, Left Ventricular Systolic Dysfunction
- How many people
- 651 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jul 2021to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Show all 9Show fewer
- Doctors, pharmacists, non-medical prescribers working at primary and secondary care.
- Able to provide informed consent.
- Age 18 and above.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals University NHS Trust
Portsmouth
About this study
Official title: BuRden of Hyperkalaemia and EValuatIon of ChangEs to Therapy with Renin-angiotensin-aldosterone System Inhibitors Following Episodes of Elevated Potassium
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.
Read the detailed description
The study aims to answer the following research questions:
- 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?
- How does it impact on RAASi prescription?
- 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?
- 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
- Keywords
- Hyperkalaemia, Heart failure with reduced ejection fraction, Renin-angiotensin-aldosterone system inhibitors, Left Ventricular Systolic Dysfunction, Decision making process, Hyperkalaemia due to RAASi
- Medical subject headings
- Hyperkalemia, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 12 months
Proportion of patients with hyperkalaemia (hospitalised or attending ED) who experienced changes to RAASi after episodes of hyperkalaemia
- Proportion of hospitalised patients/ED attenders with documented hyperkalaemia, receiving RAASi for prognostic benefit who experience RAASi dose reduction/withdrawal, assessed at discharge
Measured: 12 months
Secondary outcomes (7)
Incidence of repeated episodes of hyperkalaemia
Incidence of repeated episodes of hyperkalaemia after initial episode.
Measured: 12 months
RAASi discontinuation due to other causes rather than hyperkalaemia
Proportion of patients discontinuing RAASi due to other causes than hyperkalaemia (hypotension, worsening renal function, other).
Measured: 12 months
Mortality
Number and causes (all cause, cardiovascular or HF) of mortality at 12 months.
Measured: 12 months
Hospitalisations
Number and causes (all cause, cardiovascular or HF) of hospitalisation at 12 months.
Measured: 12 months
Hyperkalaemia level at which healthcare professionals make changes to RAASi
Level of hyperkalaemia at which healthcare professionals reduce/stop RAASi in patients with and without clear prognostic indications for RAASi.
Measured: 12 months
Description of healthcare professionals making changes to RAASi after episodes of hyperkalaemia
Proportion of different grades and specialties of healthcare professionals reducing dose/stopping RAASi in hyperkalaemic patients.
Measured: 12 months
Awareness of RAASi benefits and target doses for patients with HFrEF
Proportion of different grades and specialties of healthcare professionals who are aware of RAASi target doses and benefits in HFrEF.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start12 Jul 2021
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor
- Investigators
- Paul R Kalra, Professor, Principal investigator, Queen Alexandra Hospital, Portsmouth, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249648
- Sponsor's protocol ID
- PHT/2020/11
- Acronym
- REVIEW
- Status last verified
- Nov 2024
- First submitted
- 29 Jan 2020
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IDP
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BuRden of Hyperkalaemia and EValuatIon of ChangEs to Therapy with Renin-angiotensin-aldosterone System Inhibitors Following Episodes of Elevated Potassium
- ClinicalTrials.gov ID
- NCT04249648
- Acronym / sponsor ID
- REVIEW / PHT/2020/11
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- Vifor Pharma
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- How does it impact on RAASi prescription?
- 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?
- 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)?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- For patients with hyperkalaemia
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of hyperkalaemia in patients with new diagnosis of HFrEF
Time frame: 12 months
Incidence of hyperkalaemia in patients with new heart failure with reduced ejection fraction started on renin-angiotensin-aldosterone receptor inhibitor(s)
Frequency of dose reduction/withdrawal for RAASi after hyperkalaemia in patients with HFrEF
Time frame: 12 months
Proportion of patients with new HFrEF started on RAASi who experienced RAASi dose reduction/withdrawal/prevention of dose uptitration due to hyperkalaemia.
Proportion of patients with hyperkalaemia (hospitalised or attending ED) who experienced changes to RAASi after episodes of hyperkalaemia
Time frame: 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
7 secondary outcomes
Incidence of repeated episodes of hyperkalaemia
Time frame: 12 months
RAASi discontinuation due to other causes rather than hyperkalaemia
Time frame: 12 months
Mortality
Time frame: 12 months
Hospitalisations
Time frame: 12 months
Hyperkalaemia level at which healthcare professionals make changes to RAASi
Time frame: 12 months
Description of healthcare professionals making changes to RAASi after episodes of hyperkalaemia
Time frame: 12 months
Awareness of RAASi benefits and target doses for patients with HFrEF
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No. No plan to share IDP
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul R Kalra, Professor principal investigator
Queen Alexandra Hospital, Portsmouth, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkalaemia and Heart Failure with Reduced Ejection Fraction, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hyperkalaemia in patients with new diagnosis of HFrEF (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.