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

H

Haiyan Wang

Status

Completed

Conditions

End Stage Renal Disease
Arteriovenous Fistula

Treatments

Procedure: AVF
Procedure: Hemodialysis pathway

Study type

Observational

Funder types

Other

Identifiers

NCT06199609
YXLL-KY-2023(130)

Details and patient eligibility

About

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.

Full description

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; 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; 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.

Enrollment

2,027 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)

Trial design

2,027 participants in 4 patient groups

AVF group and TCC group
Description:
AVF and TCC are two different hemodialysis pathways
Treatment:
Procedure: Hemodialysis pathway
Before AVF establishment and After AVF establishment
Description:
Evaluate and analyze the changes in cardiac structure and function before and after the establishment of AVF;
Treatment:
Procedure: AVF
Left atrial enlargement group and Left atrial normal group
Description:
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
Treatment:
Procedure: AVF
Atrial fibrillation group and Non atrial fibrillation group
Description:
Divide AVF group patients into atrial fibrillation group and non atrial fibrillation group based on whether new atrial fibrillation occurs after AVF establishment
Treatment:
Procedure: AVF

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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