AVF Volume Blood Flow Reduction in HD Patients

NCT ID: NCT06807138

Last Updated: 2025-02-04

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

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-20

Study Completion Date

2022-04-05

Brief Summary

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Heart failure with preserved / high cardiac output is a well-known syndrome in patients with high-flow arteriovenous fistula (AVF). However, the threshold for classifying an AVF as high-flow is currently undefined. Cardio-fistular recirculation (CFR) is often used as a criterion, with values greater than 25-30% considered cardiotoxic and associated with adverse outcomes. Additionally, CFR is one of the few easily modifiable risk factors through surgical reduction of AVF volume blood flow (Qa).

The study aimed to evaluate the extent of involution of heart structural and functional changes following Qa reduction in patients with heart failure and CFR \> 25%.

Detailed Description

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Conditions

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Chronic Kidney Disease Stage 5 Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NYHA I-II

Patients with NYHA I-II heart failure

No interventions assigned to this group

NYHA III-IV

Patients with NYHA III-IV heart failure

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* age \> 18 years
* CKD 5D
* Native arteriovenous fistula or vascular graft
* Heart failure with preserved CO (NYHA I-IV )
* Cardio-fistula recirculation ≥ 25%
* eKt/V \> 1.2
* Absence of arrhythmias (except grade I AV block)
* Absence of valvular disease (except mitral regurgitation I-II)
* Arteriovenous fistula blood flow reduction surgery

Exclusion Criteria

* Death
* Kidney transplantation
* Conversion of vascular access to central venous catheter
* Withdrawal of informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moscow Regional Research and Clinical Institute (MONIKI)

OTHER_GOV

Sponsor Role lead

Responsible Party

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Alexey Zulkarnaev

Leading Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Moscow Regional Research and Clinical Institute

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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290125

Identifier Type: -

Identifier Source: org_study_id

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