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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06394986
Other study ID # ABZ_310518
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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.
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