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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04897672
Other study ID # RECHMPL21_0344
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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