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

NCT06199609 | Completed DMC

• 1 other identifier: YXLL-KY-2023（130）
• Study Type: observational
• Target: 2,027
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Arteriovenous Fistula

Keywords

ESRD; AVF; MHD; AF; Echocardiogram

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

AVF group and TCC group

AVF and TCC are two different hemodialysis pathways

Procedure: Hemodialysis pathway

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 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

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

Interventions

Hemodialysis pathway PROCEDURE

AVF and TCC are two different vascular pathways for hemodialysis

AVF group and TCC group

AVF PROCEDURE

Left atrial changes caused by AVF establishment

Before AVF establishment and After AVF establishment; Left atrial enlargement group and Left atrial normal group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Haiyan Wang: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

Location

Related Publications (1)

• Song W, Wu L, Sun C, Kong X, Wang H. New-onset atrial fibrillation following arteriovenous fistula increases adverse clinical events in dialysis patients with end-stage renal disease. Front Cardiovasc Med. 2024 Apr 12;11:1386304. doi: 10.3389/fcvm.2024.1386304. eCollection 2024.

  PMID: 38682103 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Cardiac Ultrasound

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 10, 2024
• Study Start: September 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: January 10, 2024

Record last verified: 2023-12

Locations

CN (1)