Heart Failure Clinical Trial
Official title:
Cardio-fistular Recirculation in Patients With Chronic Heart Failure and Preserved Left Ventricle Ejection Fraction
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 |
Verified date | May 2024 |
Source | Moscow Regional Research and Clinical Institute (MONIKI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Moscow Regional Research and Clinical Institute (MONIKI) | Moscow |
Lead Sponsor | Collaborator |
---|---|
Moscow Regional Research and Clinical Institute (MONIKI) |
Russian Federation,
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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