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

Cardiovascular Diseases Clinical Trial

— CREATIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143995
• Other study ID #: KY2023-267-01
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diagnosis
• Disease
• Renal Insufficiency
• Renal Insufficiency, Chronic

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