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临床试验/NCT06199609
NCT06199609已完成不适用

Changes in Cardiac Structure and Function in Patients With End-stage Renal Disease After Establishment of Autologous Arteriovenous Fistula

Haiyan Wang1 个研究点 分布在 1 个国家目标入组 2,027 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,027
试验地点
1
主要终点
Changes in left atrial size (anterior posterior diameter) after AVF establishment

研究概览

简要总结

This study is a retrospective cohort study aimed at evaluating the impact of autologous arteriovenous fistula (AVF) on the heart, especially the left atrial structure, in patients with end-stage renal disease (ESRD) through a retrospective cohort study. The aim is to further clarify the relationship between the establishment of AVF and the occurrence of atrial fibrillation, and provide a theoretical basis for exploring the relevant mechanisms of AVF induced atrial fibrillation in the future.

详细描述

  1. Retrospective collection of ESRD patients who visited the Department of Nephrology at the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province) from January 2014 to December 2022 for hemodialysis using AVF and tunnel cuffed catheter (TCC) with a tunnel and polyester sheath. Follow up comparison of the incidence of atrial fibrillation between the two groups;
  2. Collect general clinical data (gender, age, primary disease, history, etc.), echocardiography (atrioventricular diameter, wall thickness, left ventricular ejection fraction, pulmonary artery pressure, etc.), and biochemical indicators (albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, blood creatinine, blood calcium, blood phosphorus, hemoglobin, etc.) of AVF patients, Analyze the changes in the structure of the heart, especially the left atrium, before and after the establishment of AVF, and use binary logistic regression to analyze the risk factors for new onset atrial fibrillation after AVF surgery;
  3. According to whether new atrial fibrillation occurred after AVF surgery, patients were divided into atrial fibrillation group and non atrial fibrillation group. The occurrence of adverse clinical outcomes was followed up, and the Kaplan Meier survival curve was used to analyze the impact of atrial fibrillation on patient adverse clinical outcomes. Cox regression analysis was used to explore independent risk factors for adverse clinical outcomes.

Follow up: Follow up will be conducted by a dedicated doctor from the establishment of AVF to August 31, 2023. The main endpoint events are defined as all-cause death and cardiogenic death, while the secondary endpoint events are readmission due to heart failure and stroke; During the follow-up period, patients who underwent kidney transplantation, changed dialysis methods, and did not experience endpoint events at the end of the follow-up were defined as missing data.

研究设计

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

入排标准

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

入选标准

  • ① Meets the diagnostic criteria for chronic kidney disease; ② Age ≥ 18 years old; ③ Regular dialysis patients; ④ Using AVF or TCC as the sole vascular pathway.

排除标准

  • ① Irregular dialysis patients; ② High output states such as hyperthyroidism; ③ Basic heart diseases (cardiomyopathy, severe valvular disease, intracardiac shunting, constrictive pericarditis, post heart transplant, etc.)

结局指标

主要结局

Changes in left atrial size (anterior posterior diameter) after AVF establishment

时间窗: Completed through follow-up, with an average of 2 years

Collect echocardiography data before and after AVF establishment to compare changes in the left atrium before and after establishment

Prevalence rate of atrial fibrillation

时间窗: Completed through follow-up, with an average of 4 years

Follow up comparison of the incidence of atrial fibrillation between the AVF group and the TCC group;Comparison of the incidence of atrial fibrillation before and after AVF establishment

Comparison of the incidence of clinical outcomes between the atrial fibrillation group and the non atrial fibrillation group

时间窗: Completed through follow-up, with an average of 2 years

Follow up comparison of clinical outcomes between the atrial fibrillation group and the non atrial fibrillation group, and Cox regression analysis of risk factors

次要结局

未报告次要终点

研究者

发起方
Haiyan Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Haiyan Wang

Director of Cardiac Ultrasound

Qianfoshan Hospital

研究点 (1)

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