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

NCT06394986 | Completed

• 1 other identifier: ABZ_310518
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease 5D; Heart Failure; Heart Failure NYHA Class I; Heart Failure NYHA Class II

Keywords

arteriovenous fistula; hemodialysis; cardiac output; heart failure; volume blood flow; cardio-fistular recirculation; cardiopulmonary recirculation; ejection fraction

Outcome Measures

Primary Outcomes (1)

• Change in cardio-fistular recirculation

  Change in arteriovenous fistula volume blood flow / cardiac output ratio

  One hour before and two hours after the hemodialysis session.

Study Arms (1)

Study group

Procedure: Hemodialysis session

Interventions

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.

Study group

Eligibility Criteria

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

Study Population

Stable adult patients on maintenance hemodialysis.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Moscow Regional Research and Clinical Institute (MONIKI)

Moscow, 129110, Russia

Location

MeSH Terms

Conditions

Heart Failure; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexey B Zulkarnaev, MD, Prof.

  Moscow Regional Research and Clinical Institute (MONIKI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leading Researcher in Surgical Department of Kidney Transplantation

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 1, 2024
• Study Start: June 18, 2018
• Primary Completion: February 18, 2019
• Study Completion: February 18, 2019
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

RU (1)