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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06143995
Other study ID # KY2023-267-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date July 2024

Study information

Verified date July 2023
Source Guangdong Provincial People's Hospital
Contact Chen Jiyan, PHD
Phone 86-020-83827812-10528
Email Chen-jiyan@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
China Guangdong Provincial People's Hospital Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary CKD diagnosis rates 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. 1 day
Secondary Clinical characteristics Clinical characteristics in the overall participants and groups stratified by CKD diagnosis (CKD diagnosis, and CKD non-diagnosis) will be reported in 12 months. 1 day
Secondary CKD diagnosis/treatment rate 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. 1 day
Secondary The number, types, treatment rates of medicine 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. 1 day
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