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

NCT06622915 | Recruiting

• 1 other identifier: soh_med_24_07_03MS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Nephrotic Syndrome

Outcome Measures

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

  12 months

Study Arms (2)

group A,

ACTIVE COMPARATOR

steroid dependent nephrotic syndrome

Device: Tissue Doppler imaging and Conventional Echocardiography

Group B

ACTIVE COMPARATOR

steroid resistant nephrotic syndrome

Device: Tissue Doppler imaging and Conventional Echocardiography

Interventions

Tissue Doppler imaging and Conventional Echocardiography 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

Also known as: Conventional Echocardiography

Group B; group A,

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with primary nephrotic syndrome.
• Age: 2 - 14 years.
• Both males and females

You may not qualify if:

• Patients of primary cardiac diseases (e.g., congenital or rheumatic heart disease, cardio- myopathy).
• Patients who refuse to give written informed consent to study

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 27445165 BACKGROUND

• 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.

  PMID: 16343035 BACKGROUND

• 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.

  PMID: 24901023 BACKGROUND

• 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.

  PMID: 23465106 BACKGROUND

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

alaa y Mohamed, Resident

CONTACT

01094667344; alaa.yehya@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of pediatric and neonatology department, Sohag University Hospitals

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: October 2, 2024
• Study Start: July 15, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

EG (1)