DrepaSympa: Autonomic Nervous System and Sickle Cell Disease

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT04062409

Collaborator

(none)

Enrollment

Location

16.8

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sickle cell disease (SCD) children and adults with asthma have an increased rate of vaso-occlusive crisis, acute chest syndrome episodes, and premature mortality when compared to those without asthma. We hypothesised that either asthma diagnosis and/or bronchodilator treatment may aggravate SCD via their modulating effect on autonomic nervous system.

Condition or Disease	Intervention/Treatment	Phase
Heart Rate Variability (ANS Function)

Detailed Description

Heart rate variability during pulmonary function tests (spirometry, static volumes, DLCO/DLNO, exhaled NO at multiple flow rates) including salbutamol administration will be evaluated in patients with SCD (n=60) receiving asthma treatment or not, as compared to asthmatic children without SCD (n=30) matched for ethnicity

Study Design

Study Type:

Observational

Actual Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Effect of Salbutamol on Autonomic Nervous System Dysfunction of Children With Sickle Cell Disease

Actual Study Start Date :

Jan 5, 2018

Actual Primary Completion Date :

Apr 15, 2019

Actual Study Completion Date :

May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Sickle cell patients
Asmathic patients

Outcome Measures

Primary Outcome Measures

To assess the effect of salbutamol administration on ANS in these SCD children (with and without asthma) and in control asthmatics (without SCD) [cross-sectional, one hour]
heart rate variability after salbutamol administration

Secondary Outcome Measures

To assess ANS functions in patients with SCD receiving asthma treatment or not, as compared to asthmatic children without SCD matched for ethnicity [cross-sectional, one hour]
baseline heart rate variability

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

age from 8 to 16 years (≥ 8 years and < 16 years) (spirometry and DLCO study feasible)
Sub-Saharan African or Caribbean ethnic origin.
child with sickle cell disease referred for monitoring of respiratory function in the framework of its sickle cell disease and whether or not it presents a possible disease asthmatic (asthma treatment prescribed in the past year)
or asthmatic child (typical functional signs + history of exacerbation severe hospitalized or reversible obstructive pulmonary disorder) not sickle cell
addressed for respiratory function monitoring

Exclusion Criteria:

Refusal to participate (lack of consent)
Sickle cell child of North African origin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert Debre Hospital	Paris		France	75019

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Christophe Delclaux, MD PhD, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT04062409

Other Study ID Numbers:

K170302

First Posted:

Aug 20, 2019

Last Update Posted:

Nov 18, 2019

Last Verified:

Aug 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

sickle cell disease; asthma; beta-agonist; hear rate variability

Additional relevant MeSH terms:

Anemia, Sickle Cell

Study Results

No Results Posted as of Nov 18, 2019