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

NCT ID: NCT06394986

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-18

Study Completion Date

2019-02-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

Hemodialysis session

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Moscow Regional Research and Clinical Institute (MONIKI)

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alexey Zulkarnaev

Leading Researcher in Surgical Department of Kidney Transplantation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexey B Zulkarnaev, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Moscow Regional Research and Clinical Institute (MONIKI)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Moscow Regional Research and Clinical Institute (MONIKI)

Moscow, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ABZ_310518

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.