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Completed

NCT Number: NCT06394986

Cardio-fistular Recirculation in Patients With Chronic Heart Failure and Preserved Left Ventricle Ejection Fraction

This is a single-arm cohort study aimed to evaluate change of arteriovenous fistula volume blood flow / cardiac output ratio in patients with chronic heart failure (NYHA I-II classes) and with preserved ejection fraction as a result of a hemodialysis session after a "long" interdialysis interval.

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Key information

Conditions

Chronic Kidney Disease 5D Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Heart Diseases Heart Failure Heart Failure NYHA Class I Heart Failure NYHA Class II Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moscow Regional Research and Clinical Institute (MONIKI)

Moscow, 129110, Russia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • signed informed consent,
  • > 18 years
  • maintenance ("chronic") hemodialysis,
  • native arteriovenous fistula,
  • arteriovenous fistula volume blood flow ≥1 l/min,
  • arteriovenous fistula volume blood flow / cardiac output ratio < 0.3,
  • interdialysis weight gain <5% of "dry" body weight,
  • sufficient hemodialysis dose (eKt/V > 1.2),
  • chronic heart failure (NYHA I-II classes only),
  • preserved left ventricular ejection fraction (≥50%),
  • absence of arrhythmias (except first-degree atrioventricular block block),
  • absence of heart valve disease (except mitral regurgitation grade I-II),
  • absence of intradialysis hypo/hypertension
  • "long" interdialysis interval (3 days).

Exclusion criteria

  • hypo/hypertension during or after hemodialysis,
  • arrhythmias (except first-degree atrioventricular block) after hemodialysis.

Treatment and study plan

Hemodialysis session

Procedure

Change of arteriovenous fistula volume blood flow / cardiac output ratio in patients with chronic heart failure (NYHA I-II classes) and with preserved ejection fraction as a result of a hemodialysis session will be explored.

Primary outcomes

  1. Change in cardio-fistular recirculation

    Time frame: One hour before and two hours after the hemodialysis session.

    Change in arteriovenous fistula volume blood flow / cardiac output ratio

Sponsors and collaborators

Lead sponsor

Moscow Regional Research and Clinical Institute (MONIKI)

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 1, 2024
Registry last updated
May 3, 2024

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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