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

Type 2 Diabetes Mellitus Clinical Trial

— PLACARD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336239
• Other study ID #: KS2023097
• Status: Recruiting
• Start date: December 21, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Beijing Anzhen Hospital
• Contact: Xin Du, Doctor
• Phone: 86-10-64420102
• Email: duxinheart[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Albuminuria
• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
China	Beijing Sixth Hospital	Beijing	Beijing
China	Fangshan District First Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Qinyuan County People's Hospital	Changzhi	Shanxi
China	The Fifth People's Hospital of Sichuan Province	Chendu	Sichuan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Chinese PLA Army Characteristic Medical Center	Chongqing	Chongqing
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Haidong City Second People's Hospital	Haidong	Gansu
China	Jining First People's Hospital	Jining	Shandong
China	Luoyang Sixth People's Hospita	Luoyang	Henan
China	Ruyang County People's Hospita	Luoyang	Henan
China	Jing'an District Central Hospital of Shanghai	Shanghai	Shanghai
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University Qingpu Branch	Shanghai	Shanghai
China	Shenyang Ninth People's Hospital	Shenyang	Liaoning
China	Shenyang Tenth People's Hospital	Shenyang	Liaoning
China	First Hospital of Hebei Medical University	Shijia Zhuang	Hebei
China	Tai'an First People's Hospital	Tai'an	Shandong
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Taizhou Central Hospital	Taizhou	Zhejiang
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Weihai Central Hospital	Weihai	Shandong
China	The First Affiliated Hospital of Xi'an Jiaotong University	XI Ail	Shanxi
China	Yongcheng People's Hospital	Yongcheng	Henan
China	Zhangjiagang Sixth People's Hospital	Zhangjiagang	Jiangsu
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Objective	To evaluate the prevalence of retinopathy in T2DM patients with different cardiovascular diseases attending inpatient and outpatient cardiology departments in secondary and tertiary hospitals in China.	On the day of patients enrollment.
Primary	The prevalence of albuminuria	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.	On the day of patients enrollment.
Secondary	Lthe prevalence of microalbuminuria and macroalbuminuria evels of microalbuminuria and macroalbuminuria	To evaluate the levels of microalbuminuria and macroalbuminuria of patients with type 2 diabetes mellitus (T2DM) in inpatients and outpatients cardiology departments;	On the day of patients enrollment.
Secondary	The prevalence of microalbuminuria and macroalbuminuria	To evaluate the prevalence of microalbuminuria and macroalbuminuria in patients with T2DM complicated with different cardiovascular diseases	On the day of patients enrollment.
Secondary	To evaluate the related influence factors of albuminuria and the treatment patterns of CKD patients and non-CKD patients in cardiology departments;	After outpatient patients receive feedback on their renal function tests, assess whether physicians prescribe new relevant medical orders by recording them. Evaluate the treatment patterns for CKD and non-CKD patients in the cardiology department.	On the day of patients enrollment.
Secondary	Evaluate the management of patients with type 2 diabetes mellitus and cardiovascular disease across different levels of cardiology departments in hospitals.	Collect clinical assessment data from patients (including test results and the frequency of these tests over the past year), and assess the management of patient-related risk factors and complications by physicians in hospitals of different levels based on the frequency of testing.	On the day of patients enrollment.