Prevalence and Pathophysiology of Systemic Arterial Pressure Abnormalities in Childhood Sickle Cell Disease
DrépaPA
1 other identifier
observational
200
1 country
1
Brief Summary
It is usually found that the blood pressure of adults with sickle cell disease is lower than in non-sickle cell patients. On the other hand, three recent prospective studies in children with sickle cell disease show prevalence of hypertension diagnosed by ambulatory blood pressure measurement (ABPM) ranging from 32 to 45% but on small numbers of patients (n = 54 at most). This hypertension appears to affect kidney function and has been previously associated with the risk of hemorrhagic stroke. It is therefore important to know the prevalence of hypertension in children with sickle cell disease and to determine its mechanisms. The factors which could explain this high prevalence are the increase in arterial stiffness and the increase in systemic vascular resistance linked to the alteration of the sympathovagal balance contributing to the regulation of vascular tone. Indeed, a disturbance of this balance with an increase in vasoconstrictor sympathetic tone has already been found. Hypothesis: In a subgroup of sickle cell children there is systemic hypertension (prevalence: main objective) linked to the alteration of the sympathovagal balance already established during sickle cell disease (increase in sympathetic tone and decrease in parasympathetic tone) affecting systemic vascular resistance (secondary pathophysiological objectives).
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Jun 2021
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedOctober 18, 2021
May 1, 2021
2 years
May 27, 2021
October 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ambulatory Blood Pressure Monitoring (ABPM)
mean, systolic and diastolic arterial pressure
2 years
Interventions
Blood Pressure measurement
Eligibility Criteria
childhood sickle cell disease
You may qualify if:
- child (age \<18 years);
- sub-Saharan or Caribbean origin;
- major sickle cell disease (SS, SC and Sbeta-thalassemia);
- height ≥ 120 cm; absence of treated hypertension or antihypertensive treatment;
- parents informed and not opposed to participation in research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert Debre Hospital
Paris, 75019, France
Related Publications (1)
Bokov P, Koehl B, Benzouid C, Verlhac S, Missud F, Benkerrou M, Delclaux C. No Increase in Masked Hypertension Prevalence in Children With Sickle Cell Disease in France. Am J Hypertens. 2024 Apr 15;37(5):358-365. doi: 10.1093/ajh/hpae013.
PMID: 38323455DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bérengère KOEHL, MD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2021
First Posted
June 2, 2021
Study Start
June 1, 2021
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
October 18, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share