HemodialysisNCT06622928
Ventriculo-Arterial Coupling and Intra-Dialytic Changes in Hemodialysis Patients: Prognostic Insights
An observational study of Hemodialysis and Ventriculo-arterial Coupling, run by Nazarbayev University at 1 site in Kazakhstan.
Trial summary
The acute effect of hemodialysis (HD) on left ventricular mechanics has been evaluated in several studies, however their results are not uniform. Eventually, the heart and the arterial system behave as an interconnected system and not as isolated structures; thus, the evaluation of the interaction of cardiac… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Ventriculo-arterial Coupling
- What is being tested?
- Echocardiogram
- How many people
- 384 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Oct 2024to 1 Nov 2026
- 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: The study population will consist of 384 patients with end-stage renal disease (ESRD) recruited from the B.B. NURA Center of Efferent Therapy and Hemodialysis in Astana. This center, operational since 1988, provides comprehensive hemodialysis services, including 24/7 emergency care for patients requiring renal replacement therapy.
Who may be able to join
- 18 years or older;
- Standard renal replacement schedule with 3 dialysis sessions per week;
- Dialysis vintage of at least 3 months;
- Dialysis adequacy with single-pool Kt/V \>1.2
Who cannot join
- Previous kidney transplantation
- Myocardial infarction, unstable angina or stroke during the previous 6 months;
- Severe stage III to IV congestive heart failure according to the NYHA classification;
- Chronic atrial fibrillation or other known arrhythmia;
- History of non-adherence to the prescribed weekly dialysis schedule in the previous month;
- Body mass index \>40 Kg/m2; or
- History of malignancy or other clinical conditions associated with very poor prognosis.
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
Nazarbayev University School of Medicine
Astana, 010000
Alessandro Salustri, MD, PhD, +39 339 360 9520, alessandro.salustri@nu.edu.kz
About this study
Official title: Ventriculo-arterial Coupling in Patients With End-stage Renal Disease on Hemodyalisis: Intra-dialytic Changes and Prognostic Value.
The acute effect of hemodialysis (HD) on left ventricular mechanics has been evaluated in several studies, however their results are not uniform. Eventually, the heart and the arterial system behave as an interconnected system and not as isolated structures; thus, the evaluation of the interaction of cardiac contractility with the arterial system would provide a more comprehensive understanding of the cardiovascular function and cardiac energetics. However, there have not been any studies demonstrating changes in terms of volumes, contractility, intraventricular pressure gradients distribution, and vascular properties in response to changes in loading conditions and their impact on the outcome.
With these concepts in mind, we aim to evaluate the effect of volume changes induced by HD on ventriculo-arterial coupling (VAC) computed from speckle-tracking echocardiography. In particular, we seek to study patients with end-stage renal disease (ESRD) to assess:
Read more
- VAC parameters before and after the hemodialysis session;
- The value of VAC parameters in predicting adverse outcome
Three-hundred-eighty-four patients with ESRD will be evaluated by standard 2-D echocardiography before and after the HD session. Echocardiographic speckle tracking images will be analysed off-line using a dedicated software based on a mathematical model (QStrain, Medis BV, Leiden, NL). The software reconstructs the pressure/volume (PV) loop by determining the end-systolic and end-diastolic pressure-volume relationship using the single-beat algorithms. The PV relation will be depicted for the entire cardiac cycle where each point of the curve is described as (Vt, Pt). Based on this integrated PV loop analysis, the following hemodynamic parameters will be calculated: LV systolic elastance (Ees); Arterial elastance (Ea); Ventricular-Arterial Coupling (VAC); Stroke Work (SW); Pressure-volume area (PVA); Work efficiency (WE).
Patients will be followed-up for 18 months. Primary end-point will be a composite of all-cause of death, nonfatal myocardial infarction, and hospitalization due to worsening heart failure. Secondary end-point will be a composite of cardiac death, nonfatal myocardial infarction, and hospitalization for heart failure. Event-free survival for each of the echocardiographic and VAC parameters will be assessed using Kaplan-Meier analysis and compared with a log-rank test, where each index will be dichotomized according to the median of its distribution. The prognostic value will be determined using the Cox proportional hazards model. Differences will be considered statistically significant when p \<0.05.
- Conditions
- Hemodialysis, Ventriculo-arterial Coupling
- Being tested
- Echocardiogram
- Keywords
- hemodialysis, end-stage renal disease, ventriculo-arterial coupling, advanced echocardiography, cardiac ultrasound
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramDiagnostic test
Echocardiographic Assessments:
Pre-Hemodialysis Echocardiography:
Before each hemodialysis session, echocardiograms will be performed to evaluate cardiac function and gather baseline data on ventriculo-arterial coupling (VAC) parameters. This will include recording three apical echocardiographic views (4-chamber, 2-chamber, and 3-chamber) by a trained sonographer.
Post-Hemodialysis Echocardiography:
Following the completion of the hemodialysis session, echocardiographic assessments will be repeated to measure changes in VAC parameters and other relevant cardiac metrics.
| Study group | Role | What they receive |
|---|---|---|
| End-Stage Renal Disease Patients on Hemodialysis | Patients with end-stage renal disease (ESRD) undergoing regular hemodialysis, recruited based on specific inclusion and exclusion criteria. Inclusion criteria include patients aged 18 or older, receiving a standard renal replacement therapy of three dialysis sessions per week, with a dialysis history of at least 3 months and dialysis adequacy (Kt/V >1.2). Exclusion criteria include patients with a history of kidney transplantation, recent myocardial infarction or stroke, severe heart failure, chronic atrial fibrillation, obesity (BMI >40 kg/m²), and malignancy.
Patients will undergo echocardiographic evaluations before and after dialysis, with a focus on left ventricular function and ventriculo-arterial coupling (VAC) using speckle-tracking echocardiography and pressure-volume loop analysis. Receives: Diagnostic Test: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Interdialytic Changes in Ventricular-Arterial Coupling (VAC) and Its Prognostic Value in Patients Undergoing Regular Hemodialysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies 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
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazarbayev University
- Sponsor type
- University, hospital or other
- Collaborators
- B.B.NURA, Center of efferent therapy and hemodialysis in Astana, JSC National Research Cardiac Surgery Center
- Responsible party
- Sponsor
- Investigators
- Alessandro Salustri, MD, PhD, Principal investigator, Nazarbayev University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622928
- Sponsor's protocol ID
- AP23490021
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bansal N, Zelnick L, Bhat Z, Dobre M, He J, Lash J, Jaar B, Mehta R, Raj D, Rincon-Choles H, Saunders M, Schrauben S, Weir M, Wright J, Go AS; CRIC Study Investigators. Burden and Outcomes of Heart Failure Hospitalizations in Adults With Chronic Kidney Disease. J Am Coll Cardiol. 2019 Jun 4;73(21):2691-2700. doi: 10.1016/j.jacc.2019.02.071.
PubMed 31146814Iseki K, Fukiyama K. Long-term prognosis and incidence of acute myocardial infarction in patients on chronic hemodialysis. The Okinawa Dialysis Study Group. Am J Kidney Dis. 2000 Oct;36(4):820-5. doi: 10.1053/ajkd.2000.17676.
PubMed 11007686Inuzuka R, Kass DA, Senzaki H. Novel, single-beat approach for determining both end-systolic pressure-dimension relationship and preload recruitable stroke work. Open Heart. 2016 Jun 15;3(1):e000451. doi: 10.1136/openhrt-2016-000451. eCollection 2016.
PubMed 27347424Zuo ML, Chen QY, Pu L, Shi L, Wu D, Li H, Luo X, Yin LX, Siu CW, Hong DQ, Gan H. Impact of Hemodialysis on Left Ventricular-Arterial Coupling in End-Stage Renal Disease Patients. Blood Purif. 2023;52(7-8):702-711. doi: 10.1159/000531188. Epub 2023 Aug 14.
PubMed 37579725Sasso L, Capuano A, Minco M, Paglia A, Pirozzi F, Memoli B, Carlomagno G, Petretta M, Bonaduce D. Hemodialysis does not affect ventricular-arterial coupling beyond the reduction of blood pressure and preload. Int J Cardiol. 2013 Sep 30;168(2):1553-4. doi: 10.1016/j.ijcard.2012.12.024. Epub 2013 Feb 27. No abstract available.
PubMed 23453441Salustri A, Tonti G, Pedrizzetti G, Zhankorazova A, Khamitova Z, Toktarbay B, Jumadilova D, Khvan M, Galiyeva D, Bekbossynova M, Mukarov M, Kokoshko A, Gaipov A. Intradialytic Changes and Prognostic Value of Ventriculo-Arterial Coupling in Patients With End-Stage Renal Disease: Protocol for an Observational Prospective Trial. JMIR Res Protoc. 2025 Jun 23;14:e71948. doi: 10.2196/71948.
PubMed 40550123
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventriculo-arterial Coupling in Patients With End-stage Renal Disease on Hemodyalisis: Intra-dialytic Changes and Prognostic Value.
- ClinicalTrials.gov ID
- NCT06622928
- Acronym / sponsor ID
- AP23490021
- Conditions
- Hemodialysis, Ventriculo-arterial Coupling
- Keywords
- hemodialysis, end-stage renal disease, ventriculo-arterial coupling, advanced echocardiography, cardiac ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Nazarbayev UniversityUniversity, hospital or other
- Collaborators
- B.B.NURA, Center of efferent therapy and hemodialysis in Astana, JSC National Research Cardiac Surgery Center
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 2 Oct 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.
The acute effect of hemodialysis (HD) on left ventricular mechanics has been evaluated in several studies, however their results are not uniform. Eventually, the heart and the arterial system behave as an interconnected system and not as isolated structures; thus, the evaluation of the interaction of cardiac contractility with the arterial system would provide a more comprehensive understanding of the cardiovascular function and cardiac energetics. However, there have not been any studies demonstrating changes in terms of volumes, contractility, intraventricular pressure gradients distribution, and vascular properties in response to changes in loading conditions and their impact on the outcome.
With these concepts in mind, we aim to evaluate the effect of volume changes induced by HD on ventriculo-arterial coupling (VAC) computed from speckle-tracking echocardiography. In particular, we seek to study patients with end-stage renal disease (ESRD) to assess:
- VAC parameters before and after the hemodialysis session;
- The value of VAC parameters in predicting adverse outcome
Three-hundred-eighty-four patients with ESRD will be evaluated by standard 2-D echocardiography before and after the HD session. Echocardiographic speckle tracking images will be analysed off-line using a dedicated software based on a mathematical model (QStrain, Medis BV, Leiden, NL). The software reconstructs the pressure/volume (PV) loop by determining the end-systolic and end-diastolic pressure-volume relationship using the single-beat algorithms. The PV relation will be depicted for the entire cardiac cycle where each point of the curve is described as (Vt, Pt). Based on this integrated PV loop analysis, the following hemodynamic parameters will be calculated: LV systolic elastance (Ees); Arterial elastance (Ea); Ventricular-Arterial Coupling (VAC); Stroke Work (SW); Pressure-volume area (PVA); Work efficiency (WE).
Patients will be followed-up for 18 months. Primary end-point will be a composite of all-cause of death, nonfatal myocardial infarction, and hospitalization due to worsening heart failure. Secondary end-point will be a composite of cardiac death, nonfatal myocardial infarction, and hospitalization for heart failure. Event-free survival for each of the echocardiographic and VAC parameters will be assessed using Kaplan-Meier analysis and compared with a log-rank test, where each index will be dichotomized according to the median of its distribution. The prognostic value will be determined using the Cox proportional hazards model. Differences will be considered statistically significant when p \<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End-Stage Renal Disease Patients on Hemodialysis | – | Diagnostic Test: EchocardiogramPatients with end-stage renal disease (ESRD) undergoing regular hemodialysis, recruited based on specific inclusion and exclusion criteria. Inclusion criteria include patients aged 18 or older, receiving a standard renal replacement therapy of three dialysis sessions per week, with a dialysis history of at least 3 months and dialysis adequacy (Kt/V >1.2). Exclusion criteria include patients with a history of kidney transplantation, recent myocardial infarction or stroke, severe heart failure, chronic atrial fibrillation, obesity (BMI >40 kg/m²), and malignancy. Patients will undergo echocardiographic evaluations before and after dialysis, with a focus on left ventricular function and ventriculo-arterial coupling (VAC) using speckle-tracking echocardiography and pressure-volume loop analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 384 patients with end-stage renal disease (ESRD) recruited from the B.B. NURA Center of Efferent Therapy and Hemodialysis in Astana. This center, operational since 1988, provides comprehensive hemodialysis services, including 24/7 emergency care for patients requiring renal replacement therapy.
Key inclusion criteria (4 listed)
- 18 years or older;
- Standard renal replacement schedule with 3 dialysis sessions per week;
- Dialysis vintage of at least 3 months;
- Dialysis adequacy with single-pool Kt/V \>1.2
Key exclusion criteria (7 listed)
- Previous kidney transplantation
- Myocardial infarction, unstable angina or stroke during the previous 6 months;
- Severe stage III to IV congestive heart failure according to the NYHA classification;
- Chronic atrial fibrillation or other known arrhythmia;
- History of non-adherence to the prescribed weekly dialysis schedule in the previous month;
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 |
|---|---|---|
| EchocardiogramEchocardiographic Assessments: Pre-Hemodialysis Echocardiography: Before each hemodialysis session, echocardiograms will be performed to evaluate cardiac function and gather baseline data on ventriculo-arterial coupling (VAC) parameters. This will include recording three apical echocardiographic views (4-chamber, 2-chamber, and 3-chamber) by a trained sonographer. Post-Hemodialysis Echocardiography: Following the completion of the hemodialysis session, echocardiographic assessments will be repeated to measure changes in VAC parameters and other relevant cardiac metrics. | Diagnostic test | End-Stage Renal Disease Patients on Hemodialysis |
Primary outcome
Evaluation of Interdialytic Changes in Ventricular-Arterial Coupling (VAC) and Its Prognostic Value in Patients Undergoing Regular Hemodialysis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Background: PubMed 31146814Bansal N, Zelnick L, Bhat Z, Dobre M, He J, Lash J, Jaar B, Mehta R, Raj D, Rincon-Choles H, Saunders M, Schrauben S, Weir M, Wright J, Go AS; CRIC Study Investigators. Burden and Outcomes of Heart Failure Hospitalizations in Adults With Chronic Kidney Disease. J Am Coll Cardiol. 2019 Jun 4;73(21):2691-2700. doi: 10.1016/j.jacc.2019.02.071.
- Background: PubMed 11007686Iseki K, Fukiyama K. Long-term prognosis and incidence of acute myocardial infarction in patients on chronic hemodialysis. The Okinawa Dialysis Study Group. Am J Kidney Dis. 2000 Oct;36(4):820-5. doi: 10.1053/ajkd.2000.17676.
- Background: PubMed 27347424Inuzuka R, Kass DA, Senzaki H. Novel, single-beat approach for determining both end-systolic pressure-dimension relationship and preload recruitable stroke work. Open Heart. 2016 Jun 15;3(1):e000451. doi: 10.1136/openhrt-2016-000451. eCollection 2016.
- Background: PubMed 37579725Zuo ML, Chen QY, Pu L, Shi L, Wu D, Li H, Luo X, Yin LX, Siu CW, Hong DQ, Gan H. Impact of Hemodialysis on Left Ventricular-Arterial Coupling in End-Stage Renal Disease Patients. Blood Purif. 2023;52(7-8):702-711. doi: 10.1159/000531188. Epub 2023 Aug 14.
- Background: PubMed 23453441Sasso L, Capuano A, Minco M, Paglia A, Pirozzi F, Memoli B, Carlomagno G, Petretta M, Bonaduce D. Hemodialysis does not affect ventricular-arterial coupling beyond the reduction of blood pressure and preload. Int J Cardiol. 2013 Sep 30;168(2):1553-4. doi: 10.1016/j.ijcard.2012.12.024. Epub 2013 Feb 27. No abstract available.
- Derived from this study: PubMed 40550123Salustri A, Tonti G, Pedrizzetti G, Zhankorazova A, Khamitova Z, Toktarbay B, Jumadilova D, Khvan M, Galiyeva D, Bekbossynova M, Mukarov M, Kokoshko A, Gaipov A. Intradialytic Changes and Prognostic Value of Ventriculo-Arterial Coupling in Patients With End-Stage Renal Disease: Protocol for an Observational Prospective Trial. JMIR Res Protoc. 2025 Jun 23;14:e71948. doi: 10.2196/71948.
- Individual participant dataSharing planned: Undecided
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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.
Alessandro Salustri, MD, PhD principal investigator
Nazarbayev University School of Medicine
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 Hemodialysis and Ventriculo-arterial Coupling, run by Nazarbayev University at 1 site in Kazakhstan.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Oct 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 Kazakhstan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Salustri, MD, PhD (+ 39 339 360 9520, alessandro.salustri@nu.edu.kz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Interdialytic Changes in Ventricular-Arterial Coupling (VAC) and Its Prognostic Value in Patients Undergoing Regular Hemodialysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06622928, which also lists 6 linked publications.
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 2 Oct 2024.