Clinical trial NCT05184998: Description of the Clinical Outcomes of Hospitalized Patients With Heart Failure With Different Serum Potassium Levels
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperkalemia
Hypokalemia
Heart Failure
Keywords: Hyperkalemia, Hypokalemia, Heart Failure, serum potassium,
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Fudan University
First posted: 2022-01-11
Enrollment: 6950
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Totally 6,950 HF patients with sK measurements on admission of hospitalization in CN-HF database will be included.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the percentages of patients experiencing a composite of rehospitalization for worsened HF and CV death
timeFrame: 3 year
Secondary outcomes:
measure: The percentages of patients experiencing rehospitalization for worsened HF
timeFrame: 3 years
measure: The percentages of patients experiencing CV death
timeFrame: 3 years
measure: The percentages of patients experiencing all-cause death
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Research Site
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jinming Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
References: