Sickle Cell DiseasePADRENCT02721472
Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease
A study testing micro- and macro-circulatory vascular remodelling measures not practice in routine care and Biological measures not practice in routine care in people with Sickle Cell Disease, run by Theravia at 1 site in France.
Trial summary
The purpose of this study is to evaluate the relationship between plasma DNA levels and micro- and macro-circulatory vascular remodelling in patients with sickle cell disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- micro- and macro-circulatory vascular remodelling measures not practice in routine care and Biological measures not practice in routine care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2016to 14 Nov 2019
- 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
- Age ≥ 18 years.
- Homozygous SS or Sß0 sickle cell disease patients.
- Seen in consultation for an annual clinical and para-clinical evaluation of his/her disease.
- Stable clinical condition of the disease defined as the absence of severe vaso-occlusive crises (requiring hospitalisation or a visit to the emergency unit) in the previous month and absence of transfusion in the previous 3 months.
Who cannot join
- Other haemoglobinopathy
- Known diabetes.
- Recent administration of an anticoagulant treatment at curative doses (< 48h before inclusion), or platelet-inhibiting drugs (less than 1 week prior to inclusion).
- Recent transfusion (less than 3 months prior to inclusion).
- Pregnancy or post-partum (first 40 days after giving birth).
- Recent consumption of alcohol (less than 10h), coffee (less than 3h), and tobacco (less than 36h) before inclusion.
Show all 18Show fewer
- Known infection with hepatitis B, C, and HIV infection.
- Known cancer or progressive blood disease.
- Known haemostasis or coagulation disorders.
- Progressive inflammatory or infectious diseases.
- Recent history (dating less than 3 months) of venous (pulmonary embolism, deep venous thrombosis) or arterial (acute coronary syndrome, stroke, peripheral arterial ischaemia) thromboembolic event.
- Adult patients subject to legal protection measures.
- Patients already involved in a therapeutic protocol.
- Patients not affiliated to a social security system.
- Non-inclusion criteria related to the technical requirements of the Endo-PAT:
- Known cardiac arrhythmia.
- Severe Raynaud's syndrome.
- Hand or arm deformity that prevents an EndoPAT analysis.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the relationship between plasma DNA levels and micro- and macro-circulatory vascular remodelling in patients with sickle cell disease
- Conditions
- Sickle Cell Disease
- Being tested
- micro- and macro-circulatory vascular remodelling measures not practice in routine care, Biological measures not practice in routine care
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro- and macro-circulatory vascular remodelling measures not practice in routine careProcedure or surgery
Vascular measures : reactive hyperaemia index (RHI) assessed by Endo-PAT, central aortic blood pressure, aortic augmentation index, carotid-femoral pulse wave velocity
Biological measures not practice in routine careProcedure or surgery
Biological measures : Plasma DNA level, NETs (plasma nucleosome levels), Microparticules (MPs) (total, associated with red blood cells, neutrophils, platelets), haem (total and bound to MPs), Myeloperoxydase and elastase activity, neutrophils/DNA, Annexin A5, RNA and TSP1
| Study group | Role | What they receive |
|---|---|---|
| sickle cell disease patients | Other | Sickle cell disease patients included in the study and Plasma DNA levels will be analyzed and compared in patients with a reactive hyperaemia index (RHI) < 1.67 (endothelial dysfunction) assessed by Endo-PAT 2000 versus those recorded in patients with a RHI ≥ 1.67 (no endothelial dysfunction). Receives: Procedure: micro- and macro-circulatory vascular remodelling measures not practice in routine care; Procedure: Biological measures not practice in routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of plasma DNA levels in patients with a reactive hyperaemia index (RHI) < 1.67 (endothelial dysfunction) assessed by Endo-PAT 2000 versus those recorded in patients with a RHI ≥ 1.67 (no endothelial dysfunction)
Measured: 1 days
Secondary outcomes (6)
Relationship between plasma DNA levels and cerebral micro- and macro-angiopathy assessed by CT angiography or MRI angiography and transcranial Doppler ultrasound
Measured: 1 day
Relationship between plasma DNA levels and cardiac damages
Measured: 1 day
Relationship between plasma DNA levels and pulmonary blood pressure
Measured: 1 day
Relationship between plasma DNA levels and macrocirculatory vascular measurements
Measured: 2 days
Relationship between plasma DNA levels and nephropathy
Measured: 1 day
Relationship between plasma DNA levels and a clinical index of the sickle cell disease severity in a stable condition
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start17 May 2016
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LE JEUNE Sylvain, MD, Principal investigator, Hôpital Avicenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721472
- Sponsor's protocol ID
- DRE-FR-15-1
- Acronym
- PADRE
- Status last verified
- Jan 2020
- First submitted
- 18 Mar 2016
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02721472
- Acronym / sponsor ID
- PADRE / DRE-FR-15-1
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- TheraviaIndustry (pharma, biotech, devices)
- Study start
- 17 May 2016 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 29 Mar 2016 (estimated)
- 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 purpose of this study is to evaluate the relationship between plasma DNA levels and micro- and macro-circulatory vascular remodelling in patients with sickle cell disease
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sickle cell disease patients | Other | Procedure: micro- and macro-circulatory vascular remodelling measures not practice in routine care, Procedure: Biological measures not practice in routine careSickle cell disease patients included in the study and Plasma DNA levels will be analyzed and compared in patients with a reactive hyperaemia index (RHI) < 1.67 (endothelial dysfunction) assessed by Endo-PAT 2000 versus those recorded in patients with a RHI ≥ 1.67 (no endothelial dysfunction). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Homozygous SS or Sß0 sickle cell disease patients.
- Seen in consultation for an annual clinical and para-clinical evaluation of his/her disease.
- Stable clinical condition of the disease defined as the absence of severe vaso-occlusive crises (requiring hospitalisation or a visit to the emergency unit) in the previous month and absence of transfusion in the previous 3 months.
Key exclusion criteria (18 listed)
- Other haemoglobinopathy
- Known diabetes.
- Recent administration of an anticoagulant treatment at curative doses (< 48h before inclusion), or platelet-inhibiting drugs (less than 1 week prior to inclusion).
- Recent transfusion (less than 3 months prior to inclusion).
- Pregnancy or post-partum (first 40 days after giving birth).
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 |
|---|---|---|
| micro- and macro-circulatory vascular remodelling measures not practice in routine careVascular measures : reactive hyperaemia index (RHI) assessed by Endo-PAT, central aortic blood pressure, aortic augmentation index, carotid-femoral pulse wave velocity | Procedure or surgery | sickle cell disease patients |
| Biological measures not practice in routine careBiological measures : Plasma DNA level, NETs (plasma nucleosome levels), Microparticules (MPs) (total, associated with red blood cells, neutrophils, platelets), haem (total and bound to MPs), Myeloperoxydase and elastase activity, neutrophils/DNA, Annexin A5, RNA and TSP1 | Procedure or surgery | sickle cell disease patients |
Primary outcome
Comparison of plasma DNA levels in patients with a reactive hyperaemia index (RHI) < 1.67 (endothelial dysfunction) assessed by Endo-PAT 2000 versus those recorded in patients with a RHI ≥ 1.67 (no endothelial dysfunction)
Time frame: 1 days
6 secondary outcomes
Relationship between plasma DNA levels and cerebral micro- and macro-angiopathy assessed by CT angiography or MRI angiography and transcranial Doppler ultrasound
Time frame: 1 day
Relationship between plasma DNA levels and cardiac damages
Time frame: 1 day
Relationship between plasma DNA levels and pulmonary blood pressure
Time frame: 1 day
Relationship between plasma DNA levels and macrocirculatory vascular measurements
Time frame: 2 days
Relationship between plasma DNA levels and nephropathy
Time frame: 1 day
Relationship between plasma DNA levels and a clinical index of the sickle cell disease severity in a stable condition
Time frame: 1 day
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 9 Jan 2020.
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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.
LE JEUNE Sylvain, MD principal investigator
Hôpital Avicenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro- and macro-circulatory vascular remodelling measures not practice in routine care and Biological measures not practice in routine care in people with Sickle Cell Disease, run by Theravia at 1 site in France.
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 18 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 9 Jan 2020. 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 France. 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?
Comparison of plasma DNA levels in patients with a reactive hyperaemia index (RHI) < 1.67 (endothelial dysfunction) assessed by Endo-PAT 2000 versus those recorded in patients with a RHI ≥ 1.67 (no endothelial dysfunction) (time frame: 1 days). 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 9 Jan 2020.