跳至主要内容
临床试验/NCT05645952
NCT05645952招募中不适用

Association of Obesity and Cardiovascular Outcomes in Patients With Dilated Cardiomyopathy : a Korean Nationwide Cohort Study

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30,000
试验地点
1
主要终点
Composite of Outcomes

研究概览

简要总结

In this study, the investigators evaluated the association between various measures of adiposity [BMI and waist circumference (WC)] and clinical outcomes in Asian patients with dilated cardimyopathy, using a nationwide population based cohort.

详细描述

This retrospective nationwide cohort study used administrative claims data from the Korean National Health Insurance Service (NHIS) and the combined health check-up database of the National Health Insurance Corporation between 2013 and 2020.

The investigators included patients newly diagnosed with DCMP between January 2015 and December 2020. Patients aged <20 years, those who were already diagnosed with DCMP before 2015, and those with coronary artery disease, valvular heart disease, congenital heart disease, hypothyroidism, hyperthyroidism, and the cancer were excluded from the analysis. The follow-up period was defined as the time from the index date (date of diagnosis) to each outcome event, date of death, or end of the study period (December 31, 2020), whichever came first.

Patients' demographic data, comorbidities, concomitant medications, and income level were collected from the Korean NHIS database. The recent health check-up data from the index date was also ascertained, including height, weight, waist circumference, blood pressure, health surveys, and laboratory exam. Health survey included family history, smoking history, alcohol history, and the level of individual physical activity.

According to BMI following the World Health Organization recommendation for Asian population, study patients were categorized into 5 groups: underweight, <18.5 kg/m2; normal range, 18.5 to <23 kg/m2; overweight, 23 to <25 kg/m2; obese I, 25 to <30 kg/m2; and obese II, ≥30 kg/m2[4]. The investigators defined the proportion of medical use by calculating formula with the recuperation cost and the number of the visit to hospitals.

During the follow-up period, the investigators assessed 3 clinical outcomes, including all-cause death, cardiovascular hospitalization and the recurrence rate. Clinical outcomes were mainly defined by the the International Classification of Diseases, 10th revision (ICD-10). Patients were censored at the clinical outcomes or the end of the study period (December 31, 2020), whichever came first.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients newly diagnosed with DCMP between January 2015 and December 2020.

排除标准

  • Patients aged <20 years
  • Patients already diagnosed with DCMP before 2015
  • Patients with coronary artery disease, valvular heart disease, congenital heart disease, hypothyroidism, hyperthyroidism, and the cancer

结局指标

主要结局

Composite of Outcomes

时间窗: 5 years

Death + CV hospitalization + Fatal arrest event

次要结局

  • Death(5 years)
  • CV hospitalization(5 years)
  • Fatal arrest event(5 years)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kwang-No Lee

Professor

Ajou University School of Medicine

研究点 (1)

Loading locations...

相似试验