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NCT Number: NCT06199609

Changes in Cardiac Structure and Function 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.

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Hemodialysis pathway

Procedure

AVF and TCC are two different vascular pathways for hemodialysis

AVF

Procedure

Left atrial changes caused by AVF establishment

Primary outcomes

  1. Prevalence rate of atrial fibrillation

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

    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

  2. Changes in left atrial size (anterior posterior diameter) after AVF establishment

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

    Collect echocardiography data before and after AVF establishment to compare changes in the left atrium before and after establishment

  3. Comparison of the incidence of clinical outcomes between the atrial fibrillation group and the non atrial fibrillation group

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

    Follow up comparison of clinical outcomes between the atrial fibrillation group and the non atrial fibrillation group, and Cox regression analysis of risk factors

Sponsors and collaborators

Lead sponsor

Haiyan Wang

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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