2D-speckle Tracking in Pediatric Renal Chronic Disease

Congenital Heart Disease Clinical Trial

— SPECKLEKIDNEY  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04897672
• Other study ID #: RECHMPL21_0344
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Disease
• Chronic Renal Insufficiency
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• Observational study
Observational study

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Montpellier	AP-HP - Hopital Robert Debré, Marseille University Hospital- La Timone, Toulouse University Hospital, University Hospital, Bordeaux, University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global and segmentary longitudinal 2D- speckle tracking value of the left ventricule by transthoracic echocardiography	Transthoracic echocardiography parameters	Baseline (1day)
Secondary	Conventional echocardiography parameters	ransthoracic echocardiography parameters	Baseline (1day)
Secondary	Exercice capacity	Cardiopulmonary exercice test with VO2max assessment	Baseline (1day)