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OpenTrials
Completed

NCT Number: NCT06807138

AVF Volume Blood Flow Reduction in HD Patients

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%.

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Key information

Conditions

Chronic Kidney Disease Stage 5 Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Moscow Regional Research and Clinical Institute

Moscow, 129337, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Moscow Regional Research and Clinical Institute (MONIKI)

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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