Clinical trial NCT04897672: 2D-speckle Tracking in Pediatric Renal Chronic Disease
Official title: Use of 2D-Speckle Tracking Echocardiography in a Pediatric Population With Chronic Renal Disease: a Multicentre Cross-sectional Controlled Study (SPECKLE-KIDNEY-PED)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Disease
Chronic Renal Insufficiency
Congenital Heart Disease
Keywords: Speckle-tracking
Exercice capacity
Cardiovascular prognosis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: University Hospital, Toulouse
name: University Hospital, Bordeaux
name: University Hospital, Limoges
name: Marseille University Hospital- La Timone
name: AP-HP - Hopital Robert Debré
First posted: 2021-05-21
Enrollment: 170
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Detailed description: Kidney disease and chronic kidney failure are one of the most common causes of chronic childhood disease. They are often complicated by cardiovascular disease, which can, in the long run, affect patients' prognosis. Thus, mortality in children undergoing hemodialysis for end-stage kidney failure is related in more than 30% of cases to a cardiovascular complication. An annual cardiac assessment is recommended as part of the follow-up of these patients to assess the cardiac impact of kidney disease (high blood pressure, hyper-uremia, etc.). The use of conventional cardiological assessment parameters does not predict the cardiovascular prognosis of patients because the alteration of these parameters is greatly delayed in the course of the disease. 2D strain or "speckle tracking echocardiography" is a non-invasive ultrasound technique that allows for a more sensitive assessment of myocardial tissue damage and its early impairment has been shown as a factor of poor prognosis in other pediatric chronic pathology (neuromuscular disease, cardiotoxic exposure, etc.) as well as in adult chronic kidney failure.

The SPECKLE- KIDNEY-PED trial is a multicentre observationnal controlled study. The main objective of this work is to asses the 2D strain ventricular function in children with kidney failure, to compare it with that of healthy children of 6 to 17 years old, and to correlate it with the cardio-renal severity of the disease in terms of level of kidney failure and aerobic physical fitness.

The secondary objective is to assess, in this population, the level of exercice capacity and to compare it to the general population of children of the same age.

A total of 180 children are recquired to observe a significant difference of 2,5% of the global strain value with a power of 90% and an alpha risk of 5%.

The SPECKLE- KIDNEY-PED trial intends to improve the level of evidence for future guidelines on cardiologic survey and promotion of physical activity in this population

Eligibility criteria: Inclusion criteria:

* 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)

Exclusion criteria:

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

Primary outcomes:
measure: Global and segmentary longitudinal 2D- speckle tracking value of the left ventricule by transthoracic echocardiography
timeFrame: Baseline (1day)
Secondary outcomes:
measure: Conventional echocardiography parameters
timeFrame: Baseline (1day)
measure: Exercice capacity
timeFrame: Baseline (1day)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Pascal AMEDRO, MD-PhD
role: STUDY_DIRECTOR
affiliation: UH MONTPELLIER
name: Oscar WERNER, MD
role: PRINCIPAL_INVESTIGATOR
References: