ClinicalTrials.gg
RecruitingNCT06622915Updated Oct 2, 2024

Cardiac Performance Evaluation in Children With Steroid Dependent vs Steroid Resistant Nephrotic Syndrome

An interventional study of Tissue Doppler imaging and Conventional Echocardiography in Nephrotic Syndrome, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 2 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by Sohag University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
2 Years to 14 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Nephrotic Syndrome with a site in Egypt — 5 open to participants now, 6 under way, 1 of them phase 3. Nephrotic Syndrome · Egypt.

Started
2024
with 2 others
No phase
3 of 10
2 open now
Registered
7th of 10
by date
Lead sponsor
3 of 10
Sohag University

Among the 10 studies in Nephrotic Syndrome with a site in Egypt, this one is one of 3 that started in 2024, is one of 3 with no phase, and was the 7th registered.

Nephrotic Syndrome

191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.

Browse Nephrotic Syndrome studies →

Open to participants now

5 of the 10 studies in Nephrotic Syndrome with a site in Egypt are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 50 Nephrotic Syndrome studies recruiting now, 23 (46%) set no upper age limit and 22 (44%) stop at 75 or younger; 37 take children under 18; 4 take healthy volunteers.

This study: 2 Years to 14 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Nephrotic Syndrome with a site in Egypt, or all of them as a file.
02

Study summary

nephrotic syndrome (NS) is one of the most common pediatric kidney diseases There is an increased incidence of heart disease in patients with primary nephrotic syndrome (PNS) compared to the normal population Conventional Echocardiography is usually utilized to diagnose myocardial dysfunction. Tissue Doppler imaging is a non-invasive cardiac imaging technique which measures the velocity of the longitudinal motion of the mitral annulus, tricuspid annulus and the basal part of interventricular septum

03

Conditions studied

  • Nephrotic Syndrome

Browse trials for

04

Who can participate

Ages eligible
2 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children with primary nephrotic syndrome.

    • Age: 2 - 14 years.
    • Both males and females

Exclusion criteria

Exclusion Criteria:

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

Patients who refuse to give written to study

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    group A,

    steroid dependent nephrotic syndrome

    Device: Tissue Doppler imaging and Conventional Echocardiography

  • Active comparator
    Group B

    steroid resistant nephrotic syndrome

    Device: Tissue Doppler imaging and Conventional Echocardiography

Interventions

  • DeviceTissue Doppler imaging and Conventional Echocardiography

    non-invasive cardiac imaging technique which measures the velocity of the longitudinal motion of the mitral annulus, tricuspid annulus and the basal part of interventricular septum

    Also known as: Conventional Echocardiography

06

What researchers measure

Primary outcomes

  1. cardiac performance evaluation in children with steroid dependent vs steroid resistant nephrotic syndrome

    compairing of myocardial performance index (MPI)(Tei index) in nephrotic dependant and resistant nephrotic syndrom by calculating ejection time (ET) of right and left ventricle and mitral closure time (MCT) using tissue doppler

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Banh THM, Hussain-Shamsy N, Patel V, Vasilevska-Ristovska J, Borges K, Sibbald C, Lipszyc D, Brooke J, Geary D, Langlois V, Reddon M, Pearl R, Levin L, Piekut M, Licht CPB, Radhakrishnan S, Aitken-Menezes K, Harvey E, Hebert D, Piscione TD, Parekh RS. Ethnic Differences in Incidence and Outcomes of Childhood Nephrotic Syndrome. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1760-1768. doi: 10.2215/CJN.00380116. Epub 2016 Jul 21. PubMed 27445165 ↗
  • Correia Pinto J, Henriques-Coelho T, Roncon-Albuquerque R Jr, Leite-Moreira AF. Differential right and left ventricular diastolic tolerance to acute afterload and NCX gene expression in Wistar rats. Physiol Res. 2006;55(5):513-526. doi: 10.33549/physiolres.930845. Epub 2005 Dec 12. PubMed 16343035 ↗
  • Ozkan G, Adar A, Ulusoy S, Bektas H, Kiris A, Fidan M, Celik S. Presence of fragmented QRS and its correlation with myocardial performance index in patients with nephrotic syndrome. Anadolu Kardiyol Derg. 2014 Aug;14(5):450-5. doi: 10.5152/akd.2014.4886. Epub 2014 Jan 28. PubMed 24901023 ↗
  • Loscalzo J. Venous thrombosis in the nephrotic syndrome. N Engl J Med. 2013 Mar 7;368(10):956-8. doi: 10.1056/NEJMcibr1209459. No abstract available. PubMed 23465106 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Jul 2025, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2024
First posted
Oct 2, 2024
StartActual
Jul 15, 2024
Primary completionEst.
Jul 15, 2025
CompletionEst.
Jul 15, 2025
Last update
Oct 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06622915
Lead sponsor
Sohag University
Responsible party
Alaa yahia Mohamed (Resident of pediatric and neonatology department, Sohag University Hospitals, Sohag University) — Principal investigator
First posted
Oct 2, 2024
Start date
Jul 15, 2024
Primary completion
Jul 15, 2025 (estimated)
Completion
Jul 15, 2025 (estimated)
Last update
Oct 2, 2024

Study contacts

alaa y Mohamed, Resident
Contact
alaa.yehya@med.sohag.edu.eg
01094667344

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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