Chronic Kidney Disease 5DNCT06394986
Cardio-fistular Recirculation in Patients With Chronic Heart Failure and Preserved Left Ventricle Ejection Fraction
An observational study of Chronic Kidney Disease 5D and Heart Failure, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease 5D, Heart Failure, Heart Failure NYHA Class I
- What is being tested?
- Hemodialysis session
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 18 Jun 2018to 18 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable adult patients on maintenance hemodialysis.
Who may be able to join
- 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,
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- 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).
Who cannot join
- hypo/hypertension during or after hemodialysis,
- arrhythmias (except first-degree atrioventricular block) after hemodialysis.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Moscow Regional Research and Clinical Institute (MONIKI)
Moscow, 129110
About this study
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.
- Conditions
- Chronic Kidney Disease 5D, Heart Failure, Heart Failure NYHA Class I, Heart Failure NYHA Class II
- Being tested
- Hemodialysis session
- Keywords
- arteriovenous fistula, hemodialysis, cardiac output, heart failure, volume blood flow, cardio-fistular recirculation, cardiopulmonary recirculation, ejection fraction
- Medical subject headings
- Heart Failure, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodialysis sessionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Not described Receives: Procedure: Hemodialysis session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardio-fistular recirculation
Change in arteriovenous fistula volume blood flow / cardiac output ratio
Measured: One hour before and two hours after the hemodialysis session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start18 Jun 2018
- Primary completion18 Feb 2019
- Study completion18 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease 5DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alexey Zulkarnaev, Moscow Regional Research and Clinical Institute (MONIKI)
- Investigators
- Alexey B Zulkarnaev, MD, Prof., Principal investigator, Moscow Regional Research and Clinical Institute (MONIKI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394986
- Sponsor's protocol ID
- ABZ_310518
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-fistular Recirculation in Patients With Chronic Heart Failure and Preserved Left Ventricle Ejection Fraction
- ClinicalTrials.gov ID
- NCT06394986
- Acronym / sponsor ID
- ABZ_310518
- Conditions
- Chronic Kidney Disease 5D, Heart Failure, Heart Failure NYHA Class I, Heart Failure NYHA Class II
- Keywords
- arteriovenous fistula, hemodialysis, cardiac output, heart failure, volume blood flow, cardio-fistular recirculation, cardiopulmonary recirculation, ejection fraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)Other government
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Hemodialysis session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable adult patients on maintenance hemodialysis.
Key inclusion criteria (14 listed)
- signed informed consent,
- > 18 years
- maintenance ("chronic") hemodialysis,
- native arteriovenous fistula,
- arteriovenous fistula volume blood flow ≥1 l/min,
Key exclusion criteria (2 listed)
- hypo/hypertension during or after hemodialysis,
- arrhythmias (except first-degree atrioventricular block) after hemodialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodialysis sessionChange 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. | Procedure or surgery | Study group |
Primary outcome
Change in cardio-fistular recirculation
Time frame: One hour before and two hours after the hemodialysis session.
Change in arteriovenous fistula volume blood flow / cardiac output ratio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey B Zulkarnaev, MD, Prof. principal investigator
Moscow Regional Research and Clinical Institute (MONIKI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease 5D and Heart Failure, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardio-fistular recirculation (time frame: One hour before and two hours after the hemodialysis session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.