The Influence of micro-and Macro Vascular Dysfunction on Clinical Severity in Adults With Sickle Cell Anemia (SS) and Sickle Cell Hemoglobin C Disease (SC)

NCT07277023 | Completed DMC

• 1 other identifier: RBM-PAP-2015/108
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to determine the implication of micro and macro vascular function on the clinical severity of SCD (SS, SC, Sß°) adults. The secondary aim of this study is to understand the contribution of several parameters, known to influence vascular function in non-SCD individuals, in SCD

Conditions

Sickle Cell Anemia

Keywords

vascular dysfunction; sickle cell anemia; hemoglobin C disease

Outcome Measures

Primary Outcomes (2)

• Microvascular Function

  What is measured: Peripheral microvascular function will be assessed using Laser Doppler flowmetry to measure hyperemia response induced by localized heat. Units: Perfusion units (PU)

  Through study completion, an average of 3 years

• Macrovascular Function (Arterial Stiffness)

  What is measured: Arterial rigidity will be evaluated using pulse wave velocity (PWV) measurements. Units: meters/second (m/s)

  Assessed through study completion, average follow-up 3 years

Secondary Outcomes (12)

• Hematological and Hemorheological Profile Complete blood count

  Through study completion, an average of 3 years

• Oxidative Stress Profile

  Through study completion, average follow-up 3 years

• Circulating Nitric Oxide Levels

  Through study completion, average follow-up 3 years

• Circulating Microparticles

  Through study completion, average follow-up 3 years

• Autonomic Nervous System Activity

  Through study completion, average follow-up 3 years

Study Arms (1)

functions micro and macro-vascular in connection the clinical

OTHER

To characterize the level of alteration of micro and macro vascular function in SCD (SS, SC and Sß°) adults measured by heat-mediated vasodilation and peripheral perfusion (Laser Doppler system) and pulse wave velocity and to test relationships between this measured vascular function and clinical severity which is based on the rate of vaso-occlusive crisis (severe if ≥ 3 per year), the rate of acute chest syndrome (severe if \> 0 per year) and/or the presence of chronic complications.

Diagnostic Test: The influence of micro-and macro vascular dysfunction on clinical severity in adults with sickle cell anemia (SS) and sickle cell hemoglobin C disease (SC)

Interventions

The influence of micro-and macro vascular dysfunction on clinical severity in adults with sickle cell anemia (SS) and sickle cell hemoglobin C disease (SC) DIAGNOSTIC_TEST

The study permit to characterize the level of alteration of micro and macro vascular function in SCD (SS, SC and Sß°) adults measured by heat-mediated vasodilation and peripheral perfusion (Laser Doppler system) and pulse wave velocity and to test relationships between this measured vascular function and clinical severity which is based on the rate of vaso-occlusive crisis (severe if ≥ 3 within the 2 preceding years) and the rate of acute chest syndrome (severe if \> 0 in the last 2 years).

functions micro and macro-vascular in connection the clinical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults ≥ 18 years old,
• medical diagnosed with SCD (genotype SS, SC or Sß°) by isoelectrofocusing or HPLC at clinical steady state at the time of the study (i.e., no blood transfusion within the last three months,
• regularly followed by the Sickle Cell Unit of the Academic Hospital of Pointe-à-Pitre (Guadeloupe) and having signed well informed the letter of agreement.

You may not qualify if:

• not at "steady-state";
• pregnancy or breast feeding;
• non-compliant patients to usual care;
• no signed informed consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

Hospital University Center of Pointe-à-Pitre

Pointe-à-Pitre, Guadeloupe, 97159, Guadeloupe

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Hemoglobin C Disease

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marie BILLAUD, Doctor in the Sickle Cell

  Hospital University Center of Pointe-à-Pitre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SCD patients are characterized by vascular alterations, with vascular function being severely affected. However, the exact contribution of vascular dysfunction in the clinical severity and the risk for frequent vaso-occlusive crises in SCD is unknown. Furthermore the factors involved in this imbalance remain unclear but it is supposed that cerebral hypoxia, the deficit in nitric oxide, abnormal blood rheology, increased microparticles levels, autonomic nervous system imbalance and a low level of physical activity as well as poor physical fitness might be involved.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 11, 2025
• Study Start: April 29, 2016
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2021
• Last Updated: December 11, 2025

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)