Sickle Cell AnemiaVASCUDREPANCT07277023
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)
A study testing 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) in people with Sickle Cell Anemia, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Anemia
- What is being tested?
- 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)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 29 Apr 2016to 29 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
- absence of acute episodes of infection, vaso-occlusive crisis or acute chest syndrome at least one month before inclusion in the study),
- 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.
Who cannot join
- not at "steady-state";
- pregnancy or breast feeding;
- non-compliant patients to usual care;
- no signed informed consent
Trial locations and contacts
1 site in 1 country.
Guadeloupe1 site
Hospital University Center of Pointe-à-Pitre
Pointe-à-Pitre, Guadeloupe, 97159
About this study
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
Read the detailed description
TSCD 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.
- Primary outcome: The primary outcome of the present study is 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.
- Secondary outcomes: To test the existence of relationships between several factors: biological (hematology, blood rheology, nitric oxide and microparticles), physiological (the autonomic nervous system activity measured by Holter electrocardiogram and tissue oxygenation (muscular and cerebral)) and physical activity level (estimated by questionnaire and accelerometer) and physical fitness (estimated by the six minute walk test with oxygen consumption measurements).
- Study design: This study has been designed as biomedical, monocentric prospective and interventional study
- Conditions
- Sickle Cell Anemia
- Being tested
- 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)
- Keywords
- vascular dysfunction, sickle cell anemia, hemoglobin C disease
- Medical subject headings
- Anemia, Sickle Cell, Hemoglobin C Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Assessed through study completion, average follow-up 3 years
Secondary outcomes (12)
Hematological and Hemorheological Profile Complete blood count
Units: g/dL (hemoglobin),
Measured: Through study completion, an average of 3 years
Oxidative Stress Profile
Plasma and erythrocyte markers of oxidative stress (e.g., malondialdehyde, glutathione).
Units: μmol/L or standardized assay units
Measured: Through study completion, average follow-up 3 years
Circulating Nitric Oxide Levels
Plasma concentration of nitric oxide metabolites. Units: μmol/L
Measured: Through study completion, average follow-up 3 years
Circulating Microparticles
Number and origin of circulating microparticles (platelet, leukocyte, erythrocyte, endothelial). Units: particles/μL
Measured: Through study completion, average follow-up 3 years
Autonomic Nervous System Activity
Heart rate variability (HRV) derived from Holter ECG recordings. Units: ms (standard deviation of NN intervals), normalized units (frequency domain parameters)
Measured: Through study completion, average follow-up 3 years
Muscle and Cerebral Oxygenation
Oxygen saturation of muscle and brain tissue using near-infrared spectroscopy (NIRS). Units: % oxygen saturation
Measured: Through study completion, average follow-up 3 years
Physical Activity and Capacity 6-minute walk test distance
Units: meters (walk test),
Measured: Through study completion, average follow-up 3 years
Effect of Hydroxyurea on Vascular Function
Units: Perfusion units (microvascular), m/s (pulse wave velocity)
Measured: Through study completion, average follow-up 3 years
Hematological and Hemorheological Profile hematocrit
Units: % (hematocrit),
Measured: Thought study completion , an average of 3 years
Hematological and Hemorheological Profile blood viscosity parameters
mPa·s (blood viscosity)
Measured: Through study completion, an average of 3 years
Physical Activity and Capacity oxygen consumption (VO2)
mL/kg/min (VO2)
Measured: Through study completion, average follow-up 3 years
Physical Activity and Capacity Accelerometer
activity counts
Measured: Through study completion, average follow-up 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start29 Apr 2016
- Primary completion29 Oct 2018
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie BILLAUD, Doctor in the Sickle Cell, Principal investigator, Hospital University Center of Pointe-à-Pitre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277023
- Sponsor's protocol ID
- RBM-PAP-2015/108
- Acronym
- VASCUDREPA
- Status last verified
- Nov 2017
- First submitted
- 27 Nov 2017
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07277023
- Acronym / sponsor ID
- VASCUDREPA / RBM-PAP-2015/108
- Conditions
- Sickle Cell Anemia
- Keywords
- vascular dysfunction, sickle cell anemia, hemoglobin C disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 29 Apr 2016 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
TSCD 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.
- Primary outcome: The primary outcome of the present study is 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.
- Secondary outcomes: To test the existence of relationships between several factors: biological (hematology, blood rheology, nitric oxide and microparticles), physiological (the autonomic nervous system activity measured by Holter electrocardiogram and tissue oxygenation (muscular and cerebral)) and physical activity level (estimated by questionnaire and accelerometer) and physical fitness (estimated by the six minute walk test with oxygen consumption measurements).
- Study design: This study has been designed as biomedical, monocentric prospective and interventional study
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| functions micro and macro-vascular in connection the clinical | Other | 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)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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,
- absence of acute episodes of infection, vaso-occlusive crisis or acute chest syndrome at least one month before inclusion in the study),
- 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.
Key exclusion criteria (4 listed)
- not at "steady-state";
- pregnancy or breast feeding;
- non-compliant patients to usual care;
- no signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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)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). | Diagnostic test | functions micro and macro-vascular in connection the clinical |
Primary outcome
Microvascular Function
Time frame: Through study completion, an average of 3 years
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)
Macrovascular Function (Arterial Stiffness)
Time frame: Assessed through study completion, average follow-up 3 years
What is measured: Arterial rigidity will be evaluated using pulse wave velocity (PWV) measurements. Units: meters/second (m/s)
12 secondary outcomes
Hematological and Hemorheological Profile Complete blood count
Time frame: Through study completion, an average of 3 years
Oxidative Stress Profile
Time frame: Through study completion, average follow-up 3 years
Circulating Nitric Oxide Levels
Time frame: Through study completion, average follow-up 3 years
Circulating Microparticles
Time frame: Through study completion, average follow-up 3 years
Autonomic Nervous System Activity
Time frame: Through study completion, average follow-up 3 years
Muscle and Cerebral Oxygenation
Time frame: Through study completion, average follow-up 3 years
Physical Activity and Capacity 6-minute walk test distance
Time frame: Through study completion, average follow-up 3 years
Effect of Hydroxyurea on Vascular Function
Time frame: Through study completion, average follow-up 3 years
Hematological and Hemorheological Profile hematocrit
Time frame: Thought study completion , an average of 3 years
Hematological and Hemorheological Profile blood viscosity parameters
Time frame: Through study completion, an average of 3 years
Physical Activity and Capacity oxygen consumption (VO2)
Time frame: Through study completion, average follow-up 3 years
Physical Activity and Capacity Accelerometer
Time frame: Through study completion, average follow-up 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie BILLAUD, Doctor in the Sickle Cell principal investigator
Hospital University Center of Pointe-à-Pitre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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) in people with Sickle Cell Anemia, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular Function (time frame: Through study completion, an average of 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.