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Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound

T

Toulouse University Hospital

Status

Completed

Conditions

Sickle Cell Disease

Treatments

Procedure: Echocardiography

Study type

Interventional

Funder types

Other

Identifiers

NCT02829580
07 307 02 (Other Identifier)

Details and patient eligibility

About

Sickle cell disease (SCD) is an inherited disorder characterized by recurrent painful crises with ischemia resulting from vascular occlusion. Adults with SCD have increased arterial stiffness and reduced flow-mediated dilation (FMD), due to impaired release of substances such as nitric oxide.

The present study assess the vascular properties of carotid and brachial arteries in children with SCD compared with a control group without cardiovascular risk factors.

Enrollment

31 patients

Sex

All

Ages

7 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Sickle cell group :

  • Children with sickle cell syndrome (SS or SC)
  • Children hospitalized in the hematology unit (day hospital)
  • The girls set must have had a negative pregnancy test.
  • One of the two holders of parental authority must have signed consent form
  • Children affiliated to a social security scheme or equivalent

Control group : Children recruited in a previous study :

  • Holders of parental authority affiliated to a social security scheme
  • Children recruited during the balance of a heart murmur or a vasovagal reaction
  • Children whose cardiological examination is normal
  • Children having no cardiovascular risk factor

Exclusion criteria

Sickle cell group :

  • Children with intercurrent diseases such as obesity, intra uterine growth retardation (IUGR), hypertension, renal failure, infectious diseases (including HIV, Hepatitis C) or chronic inflammatory
  • Children who have sickle cell crisis there is less than 1 month.

Control group :

Children with intercurrent diseases: obesity, IUGR, hypertension, renal failure, infectious diseases (including HIV, Hepatitis C) or chronic inflammatory

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

31 participants in 2 patient groups

Sickle group
Experimental group
Description:
Children with major sickle cell syndrome will have an usual Echocardiography
Treatment:
Procedure: Echocardiography
Control group
Active Comparator group
Description:
Children recruited in a previous study and who had an usual Echocardiography
Treatment:
Procedure: Echocardiography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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