2D-speckle Tracking in Pediatric Renal Chronic Disease (SPECKLEKIDNEY)

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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease; Chronic Renal Disease; Chronic Renal Insufficiency
• Intervention / Treatment: Other: Observational study

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

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global and segmentary longitudinal 2D- speckle tracking value of the left ventricule by transthoracic echocardiography	Transthoracic echocardiography parameters	Baseline (1day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conventional echocardiography parameters	ransthoracic echocardiography parameters	Baseline (1day)
Exercice capacity	Cardiopulmonary exercice test with VO2max assessment	Baseline (1day)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: University Hospital, Bordeaux; University Hospital, Limoges; Toulouse University Hospital; Marseille University Hospital- La Timone; AP-HP - Hopital Robert Debré
• Investigators: Principal Investigator: Oscar WERNER, MD, UH Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Speckle-tracking; Exercice capacity; Cardiovascular prognosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Urologic Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency; Heart Defects, Congenital
• Other Study ID Numbers: RECHMPL21_0344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No