跳至主要内容
临床试验/CTRI/2019/08/020629
CTRI/2019/08/020629已完成不适用

An Observational, Cross sectional Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India

AstraZeneca Pharma India Ltd22 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年8月30日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
22
主要终点
Determine the prevalence of LV dysfunction and HF in type 2 DM patients based on the BNP levels and echocardiography results.

研究概览

简要总结

This is an Observational, Cross sectional Study to assess thePrevalence of Heart Failure in Type 2 Diabetes Patients in IndiaThis registry would aim at identifying the prevalence of HF in Type 2 diabetic patients. The registry will also determine whether there is any association between heart failure and T2DM.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Both men and women aged ≥ 18 years 2.Diagnosed with type 2 diabetes (as per ADA Criteria [Annexure 1]) 3.Duration of diabetes for 1 year or more 4.Willing to provide written informed consent.

排除标准

  • 1.Patients with evidence of coronary artery disease – CAD (based on the clinical expertise of the physician) 2.Patients who were previously diagnosed with heart failure
  • Patients with evidence of valvular disease based on clinical judgement of the Principle Investigator (PI).
  • 4.Current treatment with digoxin 5.History or symptoms of peripheral artery disease, chronic obstructive pulmonary disease and arrhythmias 6.Patients diagnosed with stage III/IV Chronic Kidney Disease (CKD) 7.Diabetes other than type 2 diabetes mellitus.

结局指标

主要结局

Determine the prevalence of LV dysfunction and HF in type 2 DM patients based on the BNP levels and echocardiography results.

时间窗: 10 Months

次要结局

  • Correlation of LV dysfunction and heart failure with demographics and comorbidities of the patients to assess relation between them.(10 Months)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (22)

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