CREATIVE: The Diagnosis and Treatment Pattern of CKD in Patients With Cardiovascular Disease- a National Cross-sectional Study

Sponsor
Guangdong Provincial People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06143995
Collaborator
(none)
2,000
1
12
166.3

Study Details

Study Description

Brief Summary

The goal of this observational study is to learn about in a total of approximately 2000 patients with cardiovascular disease recruited from about 25 participating sites in China with eGFR<60 ml/min/1.73 m2 and/or UACR>30 mg/g at least twice 3 months apart within the previous 12 months who had been hospitalized in the cardiology department within the previous 12 months. The main questions it aims to answer are:

  • To estimate the diagnosis rate of CKD in patients with cardiovascular disease and laboratory evidence of CKD

  • To describe the CKD awareness and treatment pattern in patients with cardiovascular disease and laboratory evidence of CKD.

  • To describe the socio-demographic and clinical characteristics of CKD in patients with cardiovascular disease and laboratory evidence of CKD

Participants will be invited to undergo a baseline visit, and the demographics, lifestyle factors, clinical characteristics, and laboratory tests will be collected.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Diagnosis and Treatment Pattern of CKD in Patients With Cardiovascular Disease- a National Cross-sectional Study
    Actual Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Jul 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. CKD diagnosis rates [1 day]

      CKD diagnosis rates in overall enrolled patients and subgroups (stratified by isolated estimated glomerular filtration rate (eGFR) measurement, isolated urinary albumin-to-creatinine ratio ( UACR) measurement, and both measurements) will be assessed in 12 month.

    Secondary Outcome Measures

    1. Clinical characteristics [1 day]

      Clinical characteristics in the overall participants and groups stratified by CKD diagnosis (CKD diagnosis, and CKD non-diagnosis) will be reported in 12 months.

    2. CKD diagnosis/treatment rate [1 day]

      CKD diagnosis/treatment rate in groups stratified by of disease types (HTN, Coronary artery disease (CAD), Heart Failure (HF), type 2 diabetes mellitus (T2DM), etc.) will be assessed in 12 months.

    3. The number, types, treatment rates of medicine [1 day]

      The number, types, treatment rates of medicine (by class) for renal protection or with potential renal contraindication, awareness in the overall enrolled participants and groups stratified by CKD diagnosis (CKD diagnosis, CKD non-diagnosis) will be reported in 12 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Female and/or male aged ≥18 years

    2. Admitted to the cardiology department with diagnosed cardiovascular disease within the previous 12 months

    3. Participants with eGFR<60 ml/min/1.73 m2 and/or UACR>30 mg/g at least twice 3 months apart within the previous 12 months

    Exclusion Criteria:
    1. Participants with known eGFR<20 ml/min/1.73 m2 or undergoing dialysis or kidney transplantation

    2. Pregnant or lactating women

    3. Exposure to contrast medium or other reason leading to potential acute kidney injury since the baseline examination of eGFR/UACR

    4. Patients who were participating in or had participated in any other clinical trial within the previous 12 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangdong Provincial People's Hospital Guangzhou Guangdong China

    Sponsors and Collaborators

    • Guangdong Provincial People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guangdong Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT06143995
    Other Study ID Numbers:
    • KY2023-267-01
    First Posted:
    Nov 22, 2023
    Last Update Posted:
    Nov 22, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 22, 2023