Status:

COMPLETED

VO2max & HRQoL in Children With Sickle Cell Disease

Lead Sponsor:

University Hospital, Montpellier

Conditions:

Sickle Cell

Children

Eligibility:

All Genders

6-17 years

Brief Summary

Sickle cell disease is the most common inherited genetic disorder, accounting for 300,000 births worldwide per year. It is caused by an autosomal recessive mutation of the β-globin gene, responsible f...

Detailed Description

This prospective case-control study included sickle cell children and healthy controls from 6 to 17 years old. Patients refuse the use of medical data will be excluded. After description of the study...

Eligibility Criteria

Inclusion

  • Sickle cell children
  • Child from 6 to 17 years old, with a confirmed diagnosis of sickle cell disease (i.e., homozygous HbS/S or heterozygous HbS/C mutations), during their routine follow-up, having performed :
  • a hematology consultation : physical examination, blood test
  • a cardiology consultation : electrocardiogram, transthoracic echocardiography
  • a respiratory plethysmography
  • a CPET and to fill in the study questionnaires.

Exclusion

  • Parents' refusal to use medical data.
  • Healthy children
  • Inclusion Criteria:
  • Child from 6 to 17 years old having performed a cardio-respiratory exercise test for chest pain, dyspnea on exertion, heart murmur and whose results do not find:
  • Congenital heart disease (normal echocardiography and ECG)
  • Respiratory disease (normal FEV1 and FVC)
  • Child having performed a maximal cardio-respiratory stress exercise until exhaustion.

Key Trial Info

Start Date :

November 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 1 2022

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT05995743

Start Date

November 1 2021

End Date

November 1 2022

Last Update

August 21 2023

Active Locations (1)

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1

Pediatric and Congenital Cardiology Department, Arnaud De Villeneuve University Hospital

Montpellier, Occitanie, France, 34295