HyperkalemiaSPLENDIDNCT05184998
Description of the Clinical Outcomes of Hospitalized Patients With Heart Failure With Different Serum Potassium Levels
An observational study of Hyperkalemia and Hypokalemia, run by AstraZeneca at 1 site in China.
Trial summary
China National Heart Failure Registration Study (CN-HF) is a nationwide, hospital-based, multicentre, prospective registry study sponsored by Ministry of Science and Technology of the People's Republic of China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperkalemia, Hypokalemia, Heart Failure
- How many people
- 6,950 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2021to 13 Jul 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Totally 6,950 HF patients with sK measurements on admission of hospitalization in CN-HF database will be included.
Who may be able to join
- HF patients with sK measurements on admission of hospitalization in CN-HF database will be included in this study.
Who cannot join
- not available for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description of the Clinical Outcomes of Hospitalized Patients With Heart Failure With Different Serum Potassium Levels: Analysis of Data From the China National Heart Failure Registration Study
China National Heart Failure Registration Study (CN-HF) is a nationwide, hospital-based, multicentre, prospective registry study sponsored by Ministry of Science and Technology of the People's Republic of China. It is aimed to understand the etiology, clinical features and treatments of in-hospital HF patients in China [3].
At present, there are few studies to describe the clinical outcomes of HF patients with different sK levels in China. Utilizing the CN-HF database, this study is aimed to describe the sK levels of hospitalized HF patients and its impact to the clinical outcomes of patients.
Read the detailed description
Blood potassium disorders are a common phenomenon in patients with HF, which may be related to complications of HF (such as decreased potassium intake, renal insufficiency) and medical treatment of HF (such as diuretics, ACEi/ ARB) [9]. It is showed that abnormal changes in sK can cause myocardial cell membrane potential instability, increase the risk of malignant arrhythmia, and result in a high mortality rate [10].
Current guidelines in China recommend ACEi/ARBs, β receptor blockers, MRAs, and diuretics for treating HF patients . However, β receptor blockers, ACEi/ARB and MRA can also cause hyperkalemia , which often leads to dose reduction or even discontinuation of the medicines, it affects the patients to benefit from these treatment.
At present, there are few studies to describe the clinical outcomes of HF patients with different sK levels in China. Utilizing the CN-HF database, this study is aimed to describe the sK levels of hospitalized HF patients and its impact to the clinical outcomes of patients.
- Conditions
- Hyperkalemia, Hypokalemia, Heart Failure
- Keywords
- Hyperkalemia, Hypokalemia, Heart Failure, serum potassium,
- Medical subject headings
- Hyperkalemia, Hypokalemia, Heart Failure
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 |
|---|---|---|
| Hypokalemia group | defined as sK range (0, 3.5] mmo/L | |
| Normokalemia group | defined as sK range (3.5, 5.0] mmo/L | |
| Hyperkalemia group | defined as sK range (5.0, ~) mmo/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentages of patients experiencing a composite of rehospitalization for worsened HF and CV death
the percentages of patients experiencing a composite of rehospitalization for worsened HF and CV death during study period in hypokalemia group, normokalemia group and hyperkalemia group, will be derived using the number of patients who experienced either rehospitalization for worsened HF or CV death during study period divided by the total number of patients in each groups.
Measured: 3 year
Secondary outcomes (3)
The percentages of patients experiencing rehospitalization for worsened HF
The percentages of patients experiencing rehospitalization for worsened HF during study period in hypokalemia group, normokalemia group and hyperkalemia group will be derived using the number of patients who had experienced rehospitalization for worsened HF during the study period divided by the total number of patients in each group.
Measured: 3 years
The percentages of patients experiencing CV death
The percentages of patients experiencing CV death during study period in hypokalemia group, normokalemia group and hyperkalemia group will be derived using the number of patients who had died due to CV disease during the study period divided by the total number of patients in each group.
Measured: 3 years
The percentages of patients experiencing all-cause death
The percentages of patients experiencing all-cause death during study period in hypokalemia group, normokalemia group and hyperkalemia group will be derived using the number of patients who had died during the study period divided by the total number of patients in each group
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start30 Nov 2021
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 6,950 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Jinming Zhou, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184998
- Sponsor's protocol ID
- D9484R00002
- Acronym
- SPLENDID
- Status last verified
- Jul 2023
- First submitted
- 23 Dec 2021
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Clinical Outcomes of Hospitalized Patients With Heart Failure With Different Serum Potassium Levels: Analysis of Data From the China National Heart Failure Registration Study
- ClinicalTrials.gov ID
- NCT05184998
- Acronym / sponsor ID
- SPLENDID / D9484R00002
- Conditions
- Hyperkalemia, Hypokalemia, Heart Failure
- Keywords
- Hyperkalemia, Hypokalemia, Heart Failure, serum potassium,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,950 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 11 Jan 2022 (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.
China National Heart Failure Registration Study (CN-HF) is a nationwide, hospital-based, multicentre, prospective registry study sponsored by Ministry of Science and Technology of the People's Republic of China. It is aimed to understand the etiology, clinical features and treatments of in-hospital HF patients in China [3].
At present, there are few studies to describe the clinical outcomes of HF patients with different sK levels in China. Utilizing the CN-HF database, this study is aimed to describe the sK levels of hospitalized HF patients and its impact to the clinical outcomes of patients.
Detailed description
Blood potassium disorders are a common phenomenon in patients with HF, which may be related to complications of HF (such as decreased potassium intake, renal insufficiency) and medical treatment of HF (such as diuretics, ACEi/ ARB) [9]. It is showed that abnormal changes in sK can cause myocardial cell membrane potential instability, increase the risk of malignant arrhythmia, and result in a high mortality rate [10].
Current guidelines in China recommend ACEi/ARBs, β receptor blockers, MRAs, and diuretics for treating HF patients . However, β receptor blockers, ACEi/ARB and MRA can also cause hyperkalemia , which often leads to dose reduction or even discontinuation of the medicines, it affects the patients to benefit from these treatment.
At present, there are few studies to describe the clinical outcomes of HF patients with different sK levels in China. Utilizing the CN-HF database, this study is aimed to describe the sK levels of hospitalized HF patients and its impact to the clinical outcomes of patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypokalemia group | – | –defined as sK range (0, 3.5] mmo/L |
| Normokalemia group | – | –defined as sK range (3.5, 5.0] mmo/L |
| Hyperkalemia group | – | –defined as sK range (5.0, ~) mmo/L |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Totally 6,950 HF patients with sK measurements on admission of hospitalization in CN-HF database will be included.
Key inclusion criteria (1 listed)
- HF patients with sK measurements on admission of hospitalization in CN-HF database will be included in this study.
Key exclusion criteria (1 listed)
- not available for this study
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
the percentages of patients experiencing a composite of rehospitalization for worsened HF and CV death
Time frame: 3 year
the percentages of patients experiencing a composite of rehospitalization for worsened HF and CV death during study period in hypokalemia group, normokalemia group and hyperkalemia group, will be derived using the number of patients who experienced either rehospitalization for worsened HF or CV death during study period divided by the total number of patients in each groups.
3 secondary outcomes
The percentages of patients experiencing rehospitalization for worsened HF
Time frame: 3 years
The percentages of patients experiencing CV death
Time frame: 3 years
The percentages of patients experiencing all-cause death
Time frame: 3 years
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 10 Jul 2023.
- redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Jinming Zhou, PhD principal investigator
Fudan University
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 Hyperkalemia and Hypokalemia, run by AstraZeneca at 1 site in China.
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 1 inclusion and 1 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 10 Jul 2023. 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 China. 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?
the percentages of patients experiencing a composite of rehospitalization for worsened HF and CV death (time frame: 3 year). 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 10 Jul 2023.