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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06394986
• Other study ID #: ABZ_310518
• Status: Completed
• Start date: June 18, 2018
• Est. completion date: February 18, 2019

Study information

• Verified date: May 2024
• Source: Moscow Regional Research and Clinical Institute (MONIKI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 18, 2019
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease 5D
• Heart Failure
• Heart Failure NYHA Class I
• Heart Failure NYHA Class II
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Moscow Regional Research and Clinical Institute (MONIKI)	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Moscow Regional Research and Clinical Institute (MONIKI)

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.