Chronic Kidney Disease Stage 5NCT06807138
AVF Volume Blood Flow Reduction in HD Patients
An observational study of Chronic Kidney Disease Stage 5 and Heart Failure, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
Trial summary
Heart failure with preserved / high cardiac output is a well-known syndrome in patients with high-flow arteriovenous fistula (AVF). However, the threshold for classifying an AVF as high-flow is currently undefined. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Kidney Disease Stage 5, Heart Failure
- Type of treatment
- Injection or infusion
- How many people
- 86 participants
- Where
- 1 siteRussia
- Study dates
- 20 Dec 2018to 5 Apr 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients receiving maintenance hemodialysis treatment
Who may be able to join
- Signed informed consent
- age > 18 years
- CKD 5D
- Native arteriovenous fistula or vascular graft
- Heart failure with preserved CO (NYHA I-IV )
- Cardio-fistula recirculation ≥ 25%
Show all 10Show fewer
- eKt/V > 1.2
- Absence of arrhythmias (except grade I AV block)
- Absence of valvular disease (except mitral regurgitation I-II)
- Arteriovenous fistula blood flow reduction surgery
Who cannot join
- Death
- Kidney transplantation
- Conversion of vascular access to central venous catheter
- Withdrawal of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AVF Volume Blood Flow Reduction in HD Patients with Chronic Heart Failure
Heart failure with preserved / high cardiac output is a well-known syndrome in patients with high-flow arteriovenous fistula (AVF). However, the threshold for classifying an AVF as high-flow is currently undefined. Cardio-fistular recirculation (CFR) is often used as a criterion, with values greater than 25-30% considered cardiotoxic and associated with adverse outcomes. Additionally, CFR is one of the few easily modifiable risk factors through surgical reduction of AVF volume blood flow (Qa).
The study aimed to evaluate the extent of involution of heart structural and functional changes following Qa reduction in patients with heart failure and CFR > 25%.
- Conditions
- Chronic Kidney Disease Stage 5, Heart Failure
- Medical subject headings
- Renal Insufficiency, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NYHA I-II | Patients with NYHA I-II heart failure | |
| NYHA III-IV | Patients with NYHA III-IV heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
Measured: Before and at 6 months after surgery
Estimated pulmonary artery pressure
Measured: Before and at 6 months after surgery
E/A ratio
Measured: Before and at 6 months after surgery
Secondary outcomes (1)
NT-proBNP serum concentration
Measured: Before and at 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start20 Dec 2018
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 5Studies 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
- 86 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807138
- Sponsor's protocol ID
- 290125
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVF Volume Blood Flow Reduction in HD Patients with Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT06807138
- Acronym / sponsor ID
- 290125
- Conditions
- Chronic Kidney Disease Stage 5, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)Other government
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 4 Feb 2025 (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.
Heart failure with preserved / high cardiac output is a well-known syndrome in patients with high-flow arteriovenous fistula (AVF). However, the threshold for classifying an AVF as high-flow is currently undefined. Cardio-fistular recirculation (CFR) is often used as a criterion, with values greater than 25-30% considered cardiotoxic and associated with adverse outcomes. Additionally, CFR is one of the few easily modifiable risk factors through surgical reduction of AVF volume blood flow (Qa).
The study aimed to evaluate the extent of involution of heart structural and functional changes following Qa reduction in patients with heart failure and CFR > 25%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NYHA I-II | – | –Patients with NYHA I-II heart failure |
| NYHA III-IV | – | –Patients with NYHA III-IV heart failure |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients receiving maintenance hemodialysis treatment
Key inclusion criteria (10 listed)
- Signed informed consent
- age > 18 years
- CKD 5D
- Native arteriovenous fistula or vascular graft
- Heart failure with preserved CO (NYHA I-IV )
Key exclusion criteria (4 listed)
- Death
- Kidney transplantation
- Conversion of vascular access to central venous catheter
- Withdrawal of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left ventricular ejection fraction
Time frame: Before and at 6 months after surgery
Estimated pulmonary artery pressure
Time frame: Before and at 6 months after surgery
E/A ratio
Time frame: Before and at 6 months after surgery
1 secondary outcome
NT-proBNP serum concentration
Time frame: Before and at 6 months after surgery
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 4 Feb 2025.
- Individual participant dataSharing planned: Yes. Upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stage 5 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 10 inclusion and 4 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 4 Feb 2025. 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?
Left ventricular ejection fraction (time frame: Before and at 6 months after surgery). The study lists 3 primary outcomes in all. 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 4 Feb 2025.