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

May 1, 2024 updated by: Alexey Zulkarnaev, Moscow Regional Research and Clinical Institute (MONIKI)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 129110
        • Moscow Regional Research and Clinical Institute (MONIKI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Stable adult patients on maintenance hemodialysis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Procedure: Hemodialysis session
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One hour before and two hours after the hemodialysis session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moscow Regional Research and Clinical Institute (MONIKI)

Investigators

  • Principal Investigator: Alexey B Zulkarnaev, MD, Prof., Moscow Regional Research and Clinical Institute (MONIKI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2018

Primary Completion (Actual)

February 18, 2019

Study Completion (Actual)

February 18, 2019

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABZ_310518

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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