NCT05184998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,950

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2022

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

December 23, 2021

Last Update Submit

July 7, 2023

Conditions

HyperkalemiaHypokalemiaHeart Failure

Keywords

Hyperkalemia, Hypokalemia, Heart Failure, serum potassium,

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • The percentages of patients experiencing rehospitalization for worsened HF

    3 years

  • The percentages of patients experiencing CV death

    3 years

  • The percentages of patients experiencing all-cause death

    3 years

Study Arms (3)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Totally 6,950 HF patients with sK measurements on admission of hospitalization in CN-HF database will be included.

You may qualify if:

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

You may not qualify if:

  • not available for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Shanghai, Shanghai Municipality, China

Location

Related Links

MeSH Terms

Conditions

HyperkalemiaHypokalemiaHeart Failure

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Jinming Zhou, PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 11, 2022

Study Start

November 30, 2021

Primary Completion

July 13, 2022

Study Completion

July 13, 2022

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

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.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
More information

Locations

CN(1)