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Completed

NCT Number: NCT04897672

2D-speckle Tracking in Pediatric Renal Chronic Disease

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

Observational study

Primary outcomes

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

    Time frame: Baseline (1day)

    Transthoracic echocardiography parameters

Secondary outcomes

  1. Conventional echocardiography parameters

    Time frame: Baseline (1day)

    ransthoracic echocardiography parameters

  2. Exercice capacity

    Time frame: Baseline (1day)

    Cardiopulmonary exercice test with VO2max assessment

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Hopital Universitaire Robert-Debre
  • Marseille University Hospital- La Timone
  • University Hospital, Bordeaux
  • University Hospital, Limoges
  • University Hospital, Toulouse

Registry information

Official study title

Use of 2D-Speckle Tracking Echocardiography in a Pediatric Population With Chronic Renal Disease: a Multicentre Cross-sectional Controlled Study (SPECKLE-KIDNEY-PED)

Acronym: SPECKLEKIDNEY

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 21, 2021
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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