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

NCT ID: NCT06622915

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-07-15

Brief Summary

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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

Detailed Description

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Conditions

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Nephrotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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group A,

steroid dependent nephrotic syndrome

Group Type ACTIVE_COMPARATOR

Tissue Doppler imaging and Conventional Echocardiography

Intervention Type DEVICE

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

Group B

steroid resistant nephrotic syndrome

Group Type ACTIVE_COMPARATOR

Tissue Doppler imaging and Conventional Echocardiography

Intervention Type DEVICE

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

Interventions

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Tissue 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

Intervention Type DEVICE

Other Intervention Names

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Conventional Echocardiography

Eligibility Criteria

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Inclusion Criteria

* Children with primary nephrotic syndrome.

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

Exclusion Criteria

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

Patients who refuse to give written informed consent to study
Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Alaa yahia Mohamed

Resident of pediatric and neonatology department, Sohag University Hospitals

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University hospitals

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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alaa y Mohamed, Resident

Role: CONTACT

01094667344

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 27445165 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16343035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24901023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23465106 (View on PubMed)

Other Identifiers

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soh_med_24_07_03MS

Identifier Type: -

Identifier Source: org_study_id

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