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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05184998
• Collaborator: Fudan University (Other)
• Enrollment: 6,950
• Location: 1
• Actual Duration (Months): 7.4
• Patients Per Site Per Month: 940.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperkalemia; Hypokalemia; Heart Failure

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

• Study Type: Observational
• Actual Enrollment: 6950 participants
• Observational Model: Other
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: Nov 30, 2021
• Actual Primary Completion Date: Jul 13, 2022
• Actual Study Completion Date: Jul 13, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. the percentages of patients experiencing a composite of rehospitalization for worsened HF and CV death [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 Outcome Measures

1. The percentages of patients experiencing rehospitalization for worsened HF [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Shanghai	Shanghai	China

Sponsors and Collaborators

• AstraZeneca
• Fudan University

Investigators

• Principal Investigator: Jinming Zhou, PhD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT05184998
• Other Study ID Numbers: D9484R00002
• First Posted: Jan 11, 2022
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AstraZeneca: Hyperkalemia, Hypokalemia, Heart Failure, serum potassium,
• Additional relevant MeSH terms: Heart Failure; Hyperkalemia; Hypokalemia; Potassium Deficiency

Study Results

No Results Posted as of Aug 15, 2022