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

NCT ID: NCT06199609

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2027 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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End Stage Renal Disease Arteriovenous Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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AVF group and TCC group

AVF and TCC are two different hemodialysis pathways

Hemodialysis pathway

Intervention Type PROCEDURE

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;

AVF

Intervention Type PROCEDURE

Left atrial changes 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

AVF

Intervention Type PROCEDURE

Left atrial changes 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

AVF

Intervention Type PROCEDURE

New onset atrial fibrillation caused by AVF establishment

Interventions

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Hemodialysis pathway

AVF and TCC are two different vascular pathways for hemodialysis

Intervention Type PROCEDURE

AVF

Left atrial changes caused by AVF establishment

Intervention Type PROCEDURE

AVF

New onset atrial fibrillation caused by AVF establishment

Intervention Type PROCEDURE

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haiyan Wang

OTHER

Sponsor Role lead

Responsible Party

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Haiyan Wang

Director of Cardiac Ultrasound

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 38682103 (View on PubMed)

Other Identifiers

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YXLL-KY-2023(130)

Identifier Type: -

Identifier Source: org_study_id

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