Children on Regular HeamodialysisNCT05357014
Evaluation Of Cardiac Function In Children 0n Regular Heamodialysis
An observational study of Children on Regular Heamodialysis, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Children on Regular Heamodialysis
- What is being tested?
- echocardiography
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- May 2022to May 2023
- 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 2 to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients of primary cardiac diseases (e.g., congenital or rheumatic heart disease, cardio- myopathy).
Trial locations and contacts
1 site in 1 country.
safaa h ali, professor contact
About this study
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.
- Conditions
- Children on Regular Heamodialysis
- Being tested
- echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDiagnostic test
evaluation of cardiac function hn children on regular heamodialysis by echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mass (LVM).
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)
Measured: one year
Diastolic function .
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.
Measured: one year
The left ventricular myocardial performance index (MPI).
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study startMay 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Children on Regular HeamodialysisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ahmed Sahy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357014
- Sponsor's protocol ID
- Soh-Med-22-04-10
- Status last verified
- Apr 2022
- First submitted
- 17 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 26993814Yeh 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.
PubMed 29161313Collins 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.
PubMed 22177944Mitsnefes 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.
PubMed 22383696
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Cardiac Function In Children 0n Regular Heamodialysis
- ClinicalTrials.gov ID
- NCT05357014
- Acronym / sponsor ID
- Soh-Med-22-04-10
- Conditions
- Children on Regular Heamodialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 2 May 2022 (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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients of primary cardiac diseases (e.g., congenital or rheumatic heart disease, cardio- myopathy).
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 |
|---|---|---|
| echocardiographyevaluation of cardiac function hn children on regular heamodialysis by echocardiography | Diagnostic test | – |
Primary outcome
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)
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Background: PubMed 26993814Al-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.
- Background: PubMed 29161313Yeh 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.
- Background: PubMed 22177944Collins 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.
- Background: PubMed 22383696Mitsnefes 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.
- Individual participant dataSharing planned: Yes
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.
safaa h ali, professor contact
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 Children on Regular Heamodialysis, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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 May 2022. 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 Egypt. 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 fatma a Ahmed, resident (01061440302, fatmasahy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular mass (LVM). (time frame: one year). The study lists 3 primary outcomes in all. 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 NCT05357014, which also lists 4 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 May 2022.