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CompletedNCT06199609Updated Jan 10, 2024

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

An observational study in End Stage Renal Disease and Arteriovenous Fistula, sponsored by Haiyan Wang. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-10.

Sponsored by Haiyan Wang · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,027
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • End Stage Renal Disease
  • Arteriovenous Fistula

Keywords

  • ESRD
  • AVF
  • MHD
  • AF
  • Echocardiogram
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 2,027 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Haiyan Wang is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.)
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,027 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureHemodialysis pathway

    AVF and TCC are two different vascular pathways for hemodialysis

  • ProcedureAVF

    Left atrial changes caused by AVF establishment

  • ProcedureAVF

    New onset atrial fibrillation caused by AVF establishment

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Completed through follow-up, with an average of 4 years

  2. 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

    Time frame: Completed through follow-up, with an average of 2 years

  3. 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

    Time frame: Completed through follow-up, with an average of 2 years

07

Study locations

1 site
  • The First Affiliated Hospital of Shandong First Medical University
    Jinan, Shandong 250000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06199609
Lead sponsor
Haiyan Wang
Responsible party
Haiyan Wang (Director of Cardiac Ultrasound, Qianfoshan Hospital) — Sponsor-investigator
First posted
Jan 10, 2024
Start date
Sep 1, 2022
Primary completion
Oct 31, 2023
Completion
Nov 30, 2023
Last update
Jan 10, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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