Ventriculo-Arterial Coupling and Intra-Dialytic Changes in Hemodialysis Patients: Prognostic Insights

NCT06622928 | Not Yet Recruiting DMC

• 1 other identifier: AP23490021
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

Brief 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 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:

1. 1.VAC parameters before and after the hemodialysis session;
2. 2.The value of VAC parameters in predicting adverse outcome

Conditions

Hemodialysis; Ventriculo-arterial Coupling

Keywords

hemodialysis; end-stage renal disease; ventriculo-arterial coupling; advanced echocardiography; cardiac ultrasound

Outcome Measures

Primary Outcomes (1)

• Evaluation of Interdialytic Changes in Ventricular-Arterial Coupling (VAC) and Its Prognostic Value in Patients Undergoing Regular Hemodialysis

  1 year

Study Arms (1)

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.

Diagnostic Test: Echocardiogram

Interventions

Echocardiogram DIAGNOSTIC_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.

End-Stage Renal Disease Patients on Hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nazarbayev University: lead
• B.B.NURA, Center of efferent therapy and hemodialysis in Astana: collaborator
• JSC National Research Cardiac Surgery Center: collaborator

Study Sites (1)

Nazarbayev University School of Medicine

Astana, 010000, Kazakhstan

Location

Related Publications (6)

• 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.

  PMID: 31146814 BACKGROUND

• Iseki 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.

  PMID: 11007686 BACKGROUND

• Inuzuka 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.

  PMID: 27347424 BACKGROUND

• Zuo 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.

  PMID: 37579725 BACKGROUND

• Sasso 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.

  PMID: 23453441 BACKGROUND

• Salustri 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.

  PMID: 40550123 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Alessandro Salustri, MD, PhD

  Nazarbayev University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Salustri, MD, PhD

CONTACT

+ 39 339 360 9520; alessandro.salustri@nu.edu.kz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

KA (1)