Prevalence and Pathophysiology of Systemic Arterial Pressure Abnormalities in Childhood Sickle Cell Disease (DrépaPA)

• ClinicalTrials.gov Identifier: NCT04911049
• Recruitment Status: Recruiting
• First Posted: June 2, 2021
• Last Update Posted: October 18, 2021
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: May 27, 2021
• First Posted Date: June 2, 2021
• Last Update Posted Date: October 18, 2021
• Actual Study Start Date: June 1, 2021
• Estimated Primary Completion Date: June 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 27, 2021)

Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: 2 years ]

mean, systolic and diastolic arterial pressure

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevalence and Pathophysiology of Systemic Arterial Pressure Abnormalities in Childhood Sickle Cell Disease
• Official Title: Prevalence and Pathophysiology of Systemic Arterial Pressure Abnormalities in Childhood Sickle Cell Disease
• 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).
• Detailed Description: Main objective (200 children): To evaluate the prevalence of elevated blood pressure (former pre-hypertension) and hypertension (including masked hypertension) in children with sickle cell disease. Secondary objectives (60 children): to evaluate the prevalence of loss of nocturnal decrease in blood pressure (dipping); to evaluate arterial stiffness (pulse wave velocity: PWV) and vascular resistance (Augmentation Index, AI) in the different groups: normal, pre-hypertension and hypertension; to evaluate the cardiac sympathovagal balance by studying heart rate variability (HRV) in the three groups: normal, pre-hypertension and hypertension; to evaluate arterial in the three groups: normal, pre-hypertension and hypertension; to evaluate whether the absence of nocturnal dipping is or is not an associated factor of abnormal arterial stiffness, systemic vascular resistance, sympathovagal balance or baroreflex by comparison of subjects with normal dipping versus abnormal dipping.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: childhood sickle cell disease
• Condition: Sickle Cell Disease

Intervention

Diagnostic Test: Blood Pressure measurement

Blood Pressure measurement

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 27, 2021): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2023
• Estimated Primary Completion Date: June 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Christophe DELCLAUX, MD, PhD; +331 40 03 41 90; christophe.delclaux@aphp.fr

Contact: Bérengère KOEHL, MD; berengere.koehl@aphp.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04911049
• Other Study ID Numbers: APHP201318
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bérengère KOEHL, MD; Assistance Publique - Hôpitaux de Paris

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: May 2021