Assessing albumin levels in patients with cardiovascular disease and type 2 diabetes in China

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

This study looks at how common kidney problems are in about 3,000 patients with type 2 diabetes and heart disease in China to help improve their care and prevent serious health issues.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 27 sites (Beijing, Beijing Municipality and 26 other locations)
• Trial ID: NCT06336239 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the prevalence of albuminuria in approximately 3,000 patients with type 2 diabetes and cardiovascular disease attending cardiology departments in China. The study will be conducted across 30 clinical centers over a six-month period, focusing on both inpatient and outpatient populations. By understanding the relationship between chronic kidney disease and cardiovascular disease in these patients, the study seeks to inform prevention and treatment strategies to reduce adverse events and progression to end-stage renal disease.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with type 2 diabetes and at least one cardiovascular condition.

Not a fit: Patients who are pregnant, on dialysis, or have other specific conditions leading to elevated albuminuria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and treatment strategies for patients with cardiovascular disease and type 2 diabetes, potentially reducing the risk of kidney complications.

How similar studies have performed: While the association between cardiovascular disease and chronic kidney disease is established, this specific approach to assessing albuminuria in this patient population is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 26 other locations

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

Study contacts

• Principal investigator: Changsheng Ma, Doctor — Beijing Anzhen Hospital
• Study coordinator: Xin Du, Doctor

Conditions Cardiovascular Disease; Type 2 Diabetes Mellitus