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AVF Volume Blood Flow Reduction in HD Patients

AVF Volume Blood Flow Reduction in HD Patients with Chronic Heart Failure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06807138
Enrollment
86
Registered
2025-02-04
Start date
2018-12-20
Completion date
2022-04-05
Last updated
2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease Stage 5, Heart Failure

Brief 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%.

Interventions

None listed

Sponsors

Moscow Regional Research and Clinical Institute (MONIKI)
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Left ventricular ejection fractionBefore and at 6 months after surgery
Estimated pulmonary artery pressureBefore and at 6 months after surgery
E/A ratioBefore and at 6 months after surgery

Secondary

MeasureTime frame
NT-proBNP serum concentrationBefore and at 6 months after surgery

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026