End Stage Renal DiseaseNCT06199609
Changes in Cardiac Structure and Function After Establishment of Autologous Arteriovenous Fistula
An observational study of End Stage Renal Disease and Arteriovenous Fistula, run by Haiyan Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Arteriovenous Fistula
- What is being tested?
- Hemodialysis pathway and AVF
- Type of treatment
- Surgery or procedure
- How many people
- 2,027 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000
About this study
Official title: 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.
Read the detailed description
- 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.
- Conditions
- End Stage Renal Disease, Arteriovenous Fistula
- Being tested
- Hemodialysis pathway, AVF
- Keywords
- ESRD, AVF, MHD, AF, Echocardiogram
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodialysis pathwayProcedure or surgery
AVF and TCC are two different vascular pathways for hemodialysis
AVFProcedure or surgery
Left atrial changes caused by AVF establishment
AVFProcedure or surgery
New onset atrial fibrillation caused by AVF establishment
| Study group | Role | What they receive |
|---|---|---|
| AVF group and TCC group | AVF and TCC are two different hemodialysis pathways Receives: 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; Receives: 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 Receives: 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 Receives: Procedure: AVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Completed through follow-up, with an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Sep 2022
- Primary completion31 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,027 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haiyan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haiyan Wang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199609
- Sponsor's protocol ID
- YXLL-KY-2023（130）
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38682103
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cardiac Structure and Function in Patients With End-stage Renal Disease After Establishment of Autologous Arteriovenous Fistula
- ClinicalTrials.gov ID
- NCT06199609
- Acronym / sponsor ID
- YXLL-KY-2023（130）
- Conditions
- End Stage Renal Disease, Arteriovenous Fistula
- Keywords
- ESRD, AVF, MHD, AF, Echocardiogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,027 participants (actual)
- Lead sponsor
- Haiyan WangUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AVF group and TCC group | – | Procedure: Hemodialysis pathwayAVF and TCC are two different hemodialysis pathways |
| Before AVF establishment and After AVF establishment | – | Procedure: AVFEvaluate and analyze the changes in cardiac structure and function before and after the establishment of AVF; |
| Left atrial enlargement group and Left atrial normal group | – | Procedure: AVFPatients 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 |
| Atrial fibrillation group and Non atrial fibrillation group | – | Procedure: AVFDivide AVF group patients into atrial fibrillation group and non atrial fibrillation group based on whether new atrial fibrillation occurs after AVF establishment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodialysis pathwayAVF and TCC are two different vascular pathways for hemodialysis | Procedure or surgery | AVF group and TCC group |
| AVFLeft atrial changes caused by AVF establishment | Procedure or surgery | Before AVF establishment and After AVF establishment, Left atrial enlargement group and Left atrial normal group |
| AVFNew onset atrial fibrillation caused by AVF establishment | Procedure or surgery | Atrial fibrillation group and Non atrial fibrillation group |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 38682103Song 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.
Related trials for End Stage Renal Disease
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Arteriovenous Fistula, run by Haiyan Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence rate of atrial fibrillation (time frame: Completed through follow-up, with an average of 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06199609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.