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Completed

NCT Number: NCT02721472

Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Avicenne

Bobigny, Île-de-France Region, 93009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

micro- and macro-circulatory vascular remodelling measures not practice in routine care

Procedure

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 care

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Relationship between plasma DNA levels and cardiac damages

    Time frame: 1 day

  3. Relationship between plasma DNA levels and pulmonary blood pressure

    Time frame: 1 day

  4. Relationship between plasma DNA levels and macrocirculatory vascular measurements

    Time frame: 2 days

  5. Relationship between plasma DNA levels and nephropathy

    Time frame: 1 day

  6. Relationship between plasma DNA levels and a clinical index of the sickle cell disease severity in a stable condition

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Theravia

Industry

Registry information

Acronym: PADRE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2016
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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