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CompletedNCT06807138Updated Feb 4, 2025

AVF Volume Blood Flow Reduction in HD Patients

An observational study in Chronic Kidney Disease Stage 5 and Heart Failure, sponsored by Moscow Regional Research and Clinical Institute (MONIKI). Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Moscow Regional Research and Clinical Institute (MONIKI) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
86
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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%.

02

Conditions studied

  • Chronic Kidney Disease Stage 5
  • Heart Failure
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 86 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Moscow Regional Research and Clinical Institute (MONIKI) is the lead sponsor of 14 studies on the registry; 1 is 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 to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients receiving maintenance hemodialysis treatment

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

Exclusion Criteria:

  • Death
  • Kidney transplantation
  • Conversion of vascular access to central venous catheter
  • Withdrawal of informed consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
86 participants (actual)
Patient registry
No

Groups and cohorts

  • NYHA I-II

    Patients with NYHA I-II heart failure

  • NYHA III-IV

    Patients with NYHA III-IV heart failure

06

What researchers measure

Primary outcomes

  1. Left ventricular ejection fraction

    Time frame: Before and at 6 months after surgery

  2. Estimated pulmonary artery pressure

    Time frame: Before and at 6 months after surgery

  3. E/A ratio

    Time frame: Before and at 6 months after surgery

Secondary outcomes

  1. NT-proBNP serum concentration

    Time frame: Before and at 6 months after surgery

07

Study locations

1 site
  • Moscow Regional Research and Clinical Institute
    Moscow, 129337, Russian Federation
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References and documents

Individual participant data

Plan to share: Yes — Upon reasonable request.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2025, 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
NCT06807138
Lead sponsor
Moscow Regional Research and Clinical Institute (MONIKI)
Responsible party
Alexey Zulkarnaev (Leading Researcher, Moscow Regional Research and Clinical Institute (MONIKI)) — Principal investigator
First posted
Feb 4, 2025
Start date
Dec 20, 2018
Primary completion
Apr 5, 2022
Completion
Apr 5, 2022
Last update
Feb 4, 2025

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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