Clinical trial NCT05357014: Evaluation Of Cardiac Function In Children 0n Regular Heamodialysis
Official title: Evaluation Of Cardiac Function In Children 0n Regular Heamodialysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Children on Regular Heamodialysis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (2-18) years were undergoing regular HD, who were started on dialysis when GFR was ≤15 mL/min/1.73 m 3 three times per week, with each dialysis session lasting for 3-4 h.

Brief summary: Cardiovascular disease (CVD) is considered as the predominant cause of mortality and morbidity in chronic kidney disease (CKD) patients .

* Left ventricular diastolic and systolic dysfunction and left ventricular hy pertrophy (LVH) contribute to the increased cardiovascular mortality rate in these patients .Such changes have been observed in young adults and children on prolonged dialysis
* The cardiovascular mortality and morbidity are seen in earlier stages of CKD, and the risk is increased by multiple risk factors such as sodium and fluid retention,hypertension, anemia, inflammation and hyperparathyroidism .
* Left ventricular hypertrophy is a common finding in CKD patients \[8\] and its severity increases with increasing severity of CKD . Initially, LVH is discussed as a physiological response to volume and pressure overload. However, sustained overload in combination with CKD associated risk factors may result in maladaptive LVH characterized by structural changes in the myocardium (calcification, fibrosis and collagen accumulation), resulting in diastolic and systolic dysfunction .
* Causes of LV diastolic dysfunction are impaired active LV relaxation or decreased LV compliance.These changes are reflected in low diastolic volume for a given diastolic pressure, meaning reduced passive LV filling .
* Changes in cardiac structure and function are common among the patients with chronic kidney disease undergoing hemodialysis. As early as 1827, Richard Bright drew attention to the common presence of left ventricular hypertrophy and thickening of the aortic wall in the patients with end-stage renal disease (ESRD).
* Cardiovascular (CV) disease is the leading cause of mortality in the childhood renal replacement therapy population with long-term observational studies reporting 40-45% deaths attributable to CV disease , increasing to 57% when stratified to haemodialysis patients only . In children with CKD, left ventricular hypertrophy (LVH) is common and occurs early in the disease process with reported prevalence up to 65% and increasing to 82% in those on haemodialysis .

  * The present study stresses the importance of echocardiography as the gold standard for the diagnosis of cardiac disease in pediatric patients under maintenance HD as a high-risk population for cardiac diseases.


Eligibility criteria: Inclusion Criteria:

* All patients (2-18) years were undergoing regular HD, who were started on dialysis when GFR was ≤15 mL/min/1.73 m 3 three times per week, with each dialysis session lasting for 3-4 h.

Exclusion Criteria:

* Patients of primary cardiac diseases (e.g., congenital or rheumatic heart disease, cardio- myopathy).

Primary outcomes:
measure: Left ventricular mass (LVM).
timeFrame: one year
measure: Diastolic function .
timeFrame: one year
measure: The left ventricular myocardial performance index (MPI).
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Al-Biltagi M, Tolba OA, ElHafez MA, Abo-Elezz AA, El Kady EK, Hazza SM. Oxidative stress and cardiac dysfunction in children with chronic renal failure on regular hemodialysis. Pediatr Nephrol. 2016 Aug;31(8):1329-39. doi: 10.1007/s00467-016-3314-8. Epub 2016 Mar 18.
citation: Yeh HM, Lin TT, Yeh CF, Huang HS, Chang SN, Lin JW, Tsai CT, Lai LP, Huang YY, Chu CL. Biomarkers and echocardiography for evaluating the improvement of the ventricular diastolic function after surgical relief of hydronephrosis. PLoS One. 2017 Nov 21;12(11):e0188597. doi: 10.1371/journal.pone.0188597. eCollection 2017.
citation: Collins AJ, Foley RN, Chavers B, Gilbertson D, Herzog C, Johansen K, Kasiske B, Kutner N, Liu J, St Peter W, Guo H, Gustafson S, Heubner B, Lamb K, Li S, Li S, Peng Y, Qiu Y, Roberts T, Skeans M, Snyder J, Solid C, Thompson B, Wang C, Weinhandl E, Zaun D, Arko C, Chen SC, Daniels F, Ebben J, Frazier E, Hanzlik C, Johnson R, Sheets D, Wang X, Forrest B, Constantini E, Everson S, Eggers P, Agodoa L. 'United States Renal Data System 2011 Annual Data Report: Atlas of chronic kidney disease & end-stage renal disease in the United States. Am J Kidney Dis. 2012 Jan;59(1 Suppl 1):A7, e1-420. doi: 10.1053/j.ajkd.2011.11.015. No abstract available.
citation: Mitsnefes MM. Cardiovascular disease in children with chronic kidney disease. J Am Soc Nephrol. 2012 Apr;23(4):578-85. doi: 10.1681/ASN.2011111115. Epub 2012 Mar 1.