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

Completed

• Conditions: Chronic Kidney Disease 5D; Heart Failure NYHA Class II; Heart Failure; Heart Failure NYHA Class I
• Interventions: Procedure: Hemodialysis session

• Registration Number: NCT06394986
• Lead Sponsor: Moscow Regional Research and Clinical Institute (MONIKI)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-18
• Primary Completion: 2019-02-18
• Study Completion: 2019-02-18
• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Status Verified: 2024-05
• Study First Posted: 2024-05-01
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Hemodialysis session	-

Primary Outcome Measures

Name	Time	Method
Change in cardio-fistular recirculation	One hour before and two hours after the hemodialysis session.	Change in arteriovenous fistula volume blood flow / cardiac output ratio

Trial Locations

Locations (1)

Moscow Regional Research and Clinical Institute (MONIKI); 🇷🇺 Moscow, Russian Federation