Changes in Cardiac Structure and Function After Establishment of Autologous Arteriovenous Fistula

Completed

• Conditions: End Stage Renal Disease; Arteriovenous Fistula
• Interventions: Procedure: Hemodialysis pathway; Procedure: AVF

• Registration Number: NCT06199609
• Lead Sponsor: Haiyan Wang

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-11-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-29
• Last Update Submitted: 2023-12-29
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2027

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AVF group and TCC group	Hemodialysis pathway	AVF and TCC are two different hemodialysis pathways
Before AVF establishment and After AVF establishment	AVF	Evaluate and analyze the changes in cardiac structure and function before and after the establishment of AVF;
Left atrial enlargement group and Left atrial normal group	AVF	Patients in the AVF group are divided into a left atrial enlargement group and a left atrial normal group based on whether the left atrium has expanded after the establishment of AVF
Atrial fibrillation group and Non atrial fibrillation group	AVF	Divide AVF group patients into atrial fibrillation group and non atrial fibrillation group based on whether new atrial fibrillation occurs after AVF establishment

Primary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China