AVF Volume Blood Flow Reduction in HD Patients

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

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%.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Chronic Kidney Disease Stage 5

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 129337
    • Moscow Regional Research and Clinical Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients receiving maintenance hemodialysis treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
NYHA I-II; Patients with NYHA I-II heart failure
NYHA III-IV; Patients with NYHA III-IV heart failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Left ventricular ejection fraction	Before and at 6 months after surgery
Estimated pulmonary artery pressure	Before and at 6 months after surgery
E/A ratio	Before and at 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
NT-proBNP serum concentration	Before and at 6 months after surgery

Collaborators and Investigators

• Sponsor: Moscow Regional Research and Clinical Institute (MONIKI)

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Actual): April 5, 2022
• Study Completion (Actual): April 5, 2022

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Chronic Disease; Disease Attributes; Renal Insufficiency; Heart Failure; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 290125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No