A study to determine the burden of chronic kidney disease (CKD) and risk of heart failure (HF) in subjects with type 2 diabetes mellitus (T2DM) in India (AURA-CH study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 40
研究概览
简要总结
This is a multicenter, prospective, longitudinal, observational study designed to assess the burden of chronic kidney disease (CKD) and the risk of heart failure (HF) among adults with type 2 diabetes mellitus (T2DM) in India. Approximately 1000 participants with known T2DM will be enrolled and followed for 6 months.
At baseline and at 3 months, participants will undergo laboratory evaluations including urinary albumin-creatinine ratio (UACR), estimated glomerular filtration rate (eGFR), and NT-proBNP levels to determine CKD burden and HF risk. The study will also evaluate CKD and HF risk distribution based on demographics and comorbidities. Occurrence of major adverse cardiovascular events (MACE) will be recorded up to 6 months. As an observational study, no intervention is administered. Safety assessments include vitals, physical examination, adverse events, and monitoring of MACE throughout the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults (greater than 18 years) of either gender
- •Subjects with known T2DM (Random plasma glucose greater than or equal to 200 mg per dl or fasting plasma glucose greater than or equal to 126 mg per dl or HbA1c greater than or equal to 6.5 percent or on antidiabetic therapy) for at least 3 months
- •Subjects willing to provide informed consent and comply with study procedures.
排除标准
- •Subjects with known Diabetes Mellitus (DM) other than T2DM (Type 1 Diabetes Mellitus, maturity onset of Diabetes in young, Latent Autoimmune Diabetes in Adults)
- •Subjects with known T2DM and documented evidence of CKD and HF
- •Subjects with acute renal insufficiency or non-diabetic kidney disease (NDKD) or those on renal replacement therapy
- •Subjects with malignancy or other severe life-threatening conditions affecting study participation
- •Pregnant or lactating women.
研究者
Dr Chintan Khandhedia
Sun Pharma Laboratories Limited