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NCT Number: NCT06336239

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

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).

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Sixth Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Lthe prevalence of microalbuminuria and macroalbuminuria evels of microalbuminuria and macroalbuminuria

    Time frame: On the day of patients enrollment.

    To evaluate the levels of microalbuminuria and macroalbuminuria of patients with type 2 diabetes mellitus (T2DM) in inpatients and outpatients cardiology departments;

  2. The prevalence of microalbuminuria and macroalbuminuria

    Time frame: On the day of patients enrollment.

    To evaluate the prevalence of microalbuminuria and macroalbuminuria in patients with T2DM complicated with different cardiovascular diseases

  3. To evaluate the related influence factors of albuminuria and the treatment patterns of CKD patients and non-CKD patients in cardiology departments;

    Time frame: On the day of patients enrollment.

    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.

  4. Evaluate the management of patients with type 2 diabetes mellitus and cardiovascular disease across different levels of cardiology departments in hospitals.

    Time frame: On the day of patients enrollment.

    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.

Other outcomes

  1. Exploratory Objective

    Time frame: On the day of patients enrollment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Du, Doctor

CONTACT

[email protected]

86-10-64420102

Yu Kong, Doctor

CONTACT

86-13811901076

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Acronym: PLACARD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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