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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Arteriovenous Fistula
• Intervention / Treatment: Procedure: Hemodialysis pathway; Procedure: AVF; Procedure: AVF

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 Type: Observational
• Enrollment (Actual): 2027

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • The First Affiliated Hospital of Shandong First Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ESRD patients who underwent hemodialysis using AVF and Tunnel Cuffed Catheter (TCC) with a polyester sleeve in the Department of Nephrology at the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province) from January 2014 to December 2022.

The AVF group patients included in the analysis are required to undergo echocardiography examination within 3 months before and after the establishment of AVF, in order to conduct long-term and longitudinal evaluation of the cardiac structure and function of MHD patients.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence rate of atrial fibrillation	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	Completed through follow-up, with an average of 4 years
Changes in left atrial size (anterior posterior diameter) after AVF establishment	Collect echocardiography data before and after AVF establishment to compare changes in the left atrium before and after establishment	Completed through follow-up, with an average of 2 years
Comparison of the incidence of clinical outcomes between the atrial fibrillation group and the non atrial fibrillation group	Follow up comparison of clinical outcomes between the atrial fibrillation group and the non atrial fibrillation group, and Cox regression analysis of risk factors	Completed through follow-up, with an average of 2 years

Collaborators and Investigators

• Sponsor: Haiyan Wang

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 29, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: ESRD; Echocardiogram; AF; AVF; MHD
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Disease Attributes; Congenital Abnormalities; Renal Insufficiency; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: YXLL-KY-2023（130）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No