AVF Volume Blood Flow Reduction in HD Patients

NCT06807138 | Completed

• 1 other identifier: 290125
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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%.

Conditions

Chronic Kidney Disease Stage 5; Heart Failure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• NT-proBNP serum concentration

  Before and at 6 months after surgery

Study Arms (2)

NYHA I-II

Patients with NYHA I-II heart failure

NYHA III-IV

Patients with NYHA III-IV heart failure

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients receiving maintenance hemodialysis treatment

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Moscow Regional Research and Clinical Institute

Moscow, 129337, Russia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Heart Failure

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leading Researcher

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: December 20, 2018
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

RU (1)