Clinical trial NCT06622928: Ventriculo-Arterial Coupling and Intra-Dialytic Changes in Hemodialysis Patients: Prognostic Insights
Official title: Ventriculo-arterial Coupling in Patients With End-stage Renal Disease on Hemodyalisis: Intra-dialytic Changes and Prognostic Value.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemodialysis
Ventriculo-arterial Coupling
Keywords: hemodialysis
end-stage renal disease
ventriculo-arterial coupling
advanced echocardiography
cardiac ultrasound
Lead sponsor: Nazarbayev University
Sponsor class: OTHER
Collaborators: name: B.B.NURA, Center of efferent therapy and hemodialysis in Astana
name: JSC National Research Cardiac Surgery Center
First posted: 2024-10-02
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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. VAC parameters before and after the hemodialysis session;
2. 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 \&lt;0.05.


Eligibility criteria: Inclusion Criteria:

* 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 \&gt;1.2

Exclusion Criteria:

* 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 \&gt;40 Kg/m2; or
* History of malignancy or other clinical conditions associated with very poor prognosis.

Primary outcomes:
measure: Evaluation of Interdialytic Changes in Ventricular-Arterial Coupling (VAC) and Its Prognostic Value in Patients Undergoing Regular Hemodialysis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Nazarbayev University School of Medicine
Study officials:
affiliation: Nazarbayev University School of Medicine
name: Alessandro Salustri, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.