Description of the Clinical Outcomes of Hospitalized Patients With Heart Failure With Different Serum Potassium Levels

Heart Failure Clinical Trial

— SPLENDID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05184998
• Other study ID #: D9484R00002
• Status: Completed
• Start date: November 30, 2021
• Est. completion date: July 13, 2022

Study information

• Verified date: July 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6950
• Est. completion date: July 13, 2022
• Est. primary completion date: July 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• HF patients with sK measurements on admission of hospitalization in CN-HF database will be included in this study.

Exclusion Criteria:

• not available for this study

Related Conditions & MeSH terms

• Heart Failure
• Hyperkalemia
• Hypokalemia

Locations

Country	Name	City	State
China	Research Site	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 year
Secondary	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.	3 years
Secondary	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.	3 years
Secondary	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	3 years

External Links

•   redacted CSR Synopsis