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Clinical Trials/NCT06336239
NCT06336239
Recruiting
Not Applicable

PrevaLence of Albuminuria in Patients With CARdiovascular Disease and Type 2 Diabetes Mellitus in China: a National Cross-sectional Study

Beijing Anzhen Hospital27 sites in 1 country3,000 target enrollmentStarted: December 21, 2023Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Beijing Anzhen Hospital
Enrollment
3,000
Locations
27
Primary Endpoint
The prevalence of albuminuria

Overview

Brief Summary

The association between Cardiovascular Disease (CVD) and Chronic Kidney Disease (CKD) is well established. Traditional risk factors for CVD and CKD are similar, with type 2 diabetes mellitus (T2DM) being the most prevalent risk factor. However, CKD is underdiagnosed and undertreated in patients with CVD. Further understanding of the combination of CKD in CVD patients is important to formulate prevention and treatment strategies for CVD patients and high-risk groups, reduce adverse events in CVD patients, and prevent progression of CKD to End Stage Renal Disease (ESRD).

Detailed Description

The PLACARD study will include approximately 3,000 patients presenting to the cardiology department with type 2 diabetes and cardiovascular disease. The aim of this study was to assess the prevalence of proteinuria (urinary ACR) in type 2 diabetic patients with different cardiovascular diseases, both inpatient and outpatient in the cardiology departments of secondary and tertiary hospitals in China. Participants will be recruited at 30 clinical centers for a period of six months.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥18 years old;
  • Diagnosed T2DM combined with ≥1 CVD (hypertension, coronary heart disease, atrial fibrillation, heart failure);
  • During the data collection period, they went to the outpatient clinic of the cardiology department of the research center, or received treatment in the cardiology department;
  • Ability to self-sign informed consent (electronic /paper).

Exclusion Criteria

  • Pregnant or lactating women;
  • Dialysis patients;
  • Other diseases that lead to elevated albuminuria, such as severe infection, confirmed primary glomerular disease, etc.;
  • . Malignant tumors being treated (surgery, chemotherapy, radiotherapy or targeted therapy);
  • Cachexia (CSS score ≥ 5 points);
  • Severe liver disease (Child- Pugh grade C) ;
  • Participated in an interventional clinical trial in the past three months.

Outcomes

Primary Outcomes

The prevalence of albuminuria

Time Frame: On the day of patients enrollment.

To assess the prevalence of albuminuria in patients who are combined with type 2 diabetes mellitus and different cardiovascular diseases in inpatient and outpatient cardiology departments of secondary and tertiary hospitals in China.

Secondary Outcomes

  • Evaluate the management of patients with type 2 diabetes mellitus and cardiovascular disease across different levels of cardiology departments in hospitals.(On the day of patients enrollment.)
  • Lthe prevalence of microalbuminuria and macroalbuminuria evels of microalbuminuria and macroalbuminuria(On the day of patients enrollment.)
  • The prevalence of microalbuminuria and macroalbuminuria(On the day of patients enrollment.)
  • To evaluate the related influence factors of albuminuria and the treatment patterns of CKD patients and non-CKD patients in cardiology departments;(On the day of patients enrollment.)

Investigators

Sponsor
Beijing Anzhen Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chang sheng Ma

Director of Cardiology

Beijing Anzhen Hospital

Study Sites (27)

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