NCT06199609

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,027 (actual)
• Sponsor: Haiyan Wang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease
• Arteriovenous Fistula

Interventions

Type	Name	Description
PROCEDURE	Hemodialysis pathway	AVF and TCC are two different vascular pathways for hemodialysis
PROCEDURE	AVF	Left atrial changes caused by AVF establishment
PROCEDURE	AVF	New onset atrial fibrillation caused by AVF establishment

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-10-31
• Completion: 2023-11-30
• First posted: 2024-01-10
• Last updated: 2024-01-10

Locations

1 site across 1 country: China