2D-speckle Tracking in Pediatric Renal Chronic Disease

NCT04897672 | Completed

• 1 other identifier: RECHMPL21_0344
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The SPECKLE- KIDNEY-PED is a multicentre observational controlled trial aiming to evaluate the 2D-Speckle tracking in a population of 85 patients aged from 6 to 17 years old with a chronic renal disease and to compare the results to those of 85 age and gender-matched healthy subjects. The secondary objective is to assess the conventional echocardiographic parameters and the level of exercice capacity.

Conditions

Chronic Renal Disease; Chronic Renal Insufficiency; Congenital Heart Disease

Keywords

Speckle-tracking; Exercice capacity; Cardiovascular prognosis

Outcome Measures

Primary Outcomes (1)

• Global and segmentary longitudinal 2D- speckle tracking value of the left ventricule by transthoracic echocardiography

  Transthoracic echocardiography parameters

  Baseline (1day)

Secondary Outcomes (2)

• Conventional echocardiography parameters

  Baseline (1day)

• Exercice capacity

  Baseline (1day)

Study Arms (2)

case

case: Children aged 6 to 17 years old reffered to the pediatric cardiology consultation with a chronic renal disease and renal insufficiency

Other: Observational study

control

control : Children aged 6 to 17 years old reffered to the pediatric cardiology consultation who were classified in the control group after a completely normal check-up, including physical examination, electrocardiogram, and echocardiography

Other: Observational study

Interventions

Observational study OTHER

Observational study

case; control

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Cases group : Children aged 6 to 17years old with chronic renal insufficiency Control group: Children aged 6 to 17 years old with normal check up

You may qualify if:

• Patient aged 6 to 17 years old
• Patient with chronic renal disease (\>3 months)
• Patient with renal insufficiency (glomerular filtration rate \< 80ml/min/1,73m2)

You may not qualify if:

• Patient with associated congenital heart disease
• Patient with uncontrolled arrythmia

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• University Hospital, Toulouse: collaborator
• University Hospital, Bordeaux: collaborator
• University Hospital, Limoges: collaborator
• Marseille University Hospital- La Timone: collaborator
• AP-HP - Hopital Robert Debré: collaborator

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Heart Defects, Congenital

Interventions

Observation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Pascal AMEDRO, MD-PhD

  UH MONTPELLIER

  STUDY DIRECTOR

• Oscar WERNER, MD

  UH MONTPELLIER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

FR (1)