Autonomic Nervous System and Sickle Cell Disease

Heart Rate Variability (ANS Function) Clinical Trial

— DrepaSympa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062409
• Other study ID #: K170302
• Status: Completed
• Start date: January 5, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: August 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 31, 2019
• Est. primary completion date: April 15, 2019
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Heart Rate Variability (ANS Function)

Locations

Country	Name	City	State
France	Robert Debre Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Bokov P, El Jurdi H, Denjoy I, Peiffer C, Medjahdi N, Holvoet L, Benkerrou M, Delclaux C. Salbutamol Worsens the Autonomic Nervous System Dysfunction of Children With Sickle Cell Disease. Front Physiol. 2020 Feb 26;11:31. doi: 10.3389/fphys.2020.00031. eC — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of salbutamol administration on ANS in these SCD children (with and without asthma) and in control asthmatics (without SCD)	heart rate variability after salbutamol administration	cross-sectional, one hour
Secondary	To assess ANS functions in patients with SCD receiving asthma treatment or not, as compared to asthmatic children without SCD matched for ethnicity	baseline heart rate variability	cross-sectional, one hour