Evaluation Of Cardiac Function In Children 0n Regular Heamodialysis

April 26, 2022 updated by: Fatma Ahmed Sahy, Sohag University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: safaa H Ali, professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular mass (LVM).
Time Frame: one year
Left ventricular mass (LVM) will be calculated using the measurements obtained by two-dimensional directed M-mode echocardiography according to the American Society of Echocardiography (ASE) criteria . Indexed LVM (LVMI) will be calculated by dividing the LVM by height raised to a power of 2.7 (g/m2.7) using the formula devised by De Simone et al(De Simone G1992)
one year
Diastolic function .
Time Frame: one year
Diastolic function will be assessed by both Doppler echocardiography and tissue Doppler imaging. Early mitral inflow velocity (E), and late mitral inflow velocity (A) will be measured by Doppler echocardiography. Early (e) and late (a') peak mitral annular velocities will be measured at the medial and lateral mitral annulus using tissue Doppler. The e'/a' ratio at both annuli will be calculated. The peak early mitral annular velocity (E') will be computed as the average of the velocities at the medial and lateral annuli. Using these measurements, the ratio of Doppler-derived peak early mitral inflow velocity to tissue Doppler-derived peak early mitral annular velocity (E/E'ratio) will be calculated.
one year
The left ventricular myocardial performance index (MPI).
Time Frame: one year
The left ventricular myocardial performance index (MPI), a global index of systolic and diastolic function, will be defined as the sum of isovolumic relaxation time and isovolumic contraction time divided by ejection time.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2022

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

May 1, 2023

Study Registration Dates

First Submitted

April 17, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (ACTUAL)

May 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med-22-04-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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