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NCT Number: NCT05184998

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

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.

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Key information

Conditions

Hyperkalemia Cardiovascular Diseases Heart Diseases Heart Failure Hypokalemia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. The percentages of patients experiencing rehospitalization for worsened HF

    Time frame: 3 years

    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.

  2. The percentages of patients experiencing CV death

    Time frame: 3 years

    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. The percentages of patients experiencing all-cause death

    Time frame: 3 years

    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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Fudan University

Registry information

Official study 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

Acronym: SPLENDID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2022
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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