Congenital Heart Disease Clinical Trial
— SPECKLEKIDNEYOfficial title:
Use of 2D-Speckle Tracking Echocardiography in a Pediatric Population With Chronic Renal Disease: a Multicentre Cross-sectional Controlled Study (SPECKLE-KIDNEY-PED)
Verified date | January 2022 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Uh Montpellier | Montpellier |
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 |
France,
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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