New Therapeutic Strategy Against Preeclampsia

NCT06464159 | Recruiting

• 2 other identifiers: APHP2317722023-A01545-40
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Preeclampsia is a hypertensive disorder of pregnancy associated with important maternal and perinatal mortality. It complicates 2 to 5% of pregnancies and causes more than 70 000 maternal deaths each year worldwide. Although symptomatic management has improved there is currently no curative treatment, and only childbirth and delivery of the placenta, usually prematurely, alleviate the mother's symptoms. The management of extremely preterm infants is a major societal challenge in medical, ethical and economic terms. Placental insufficiency plays a central role in the pathophysiology of preeclampsia. Abnormal placentation during the first trimester leads to placental hypoperfusion, which induces trophoblast dysfunction and the release in maternal circulation of trophoblastic factors leading to the maternal symptoms. Among molecules that participate to the pathophysiology of preeclampsia, one of the most important players is soluble fms-like tyrosine kinase 1 (sFlt-1), which is a soluble form of the vascular endothelial growth factor (VEGF) and placenta growth factor (PlGF) receptor. sFlt-1 binds to free VEGF and PlGF in the maternal circulation, thus reducing their bioavailability for their membrane receptors. Targeting the sFlt-1 pathway is one of the most promising strategies for the development of new treatments for preeclampsia. As sFlt-1 results from alternative splicing, its peptide sequence is identical to that of the extracellular part of the membrane receptor. The development of drugs that act specifically on the soluble form and not on the membrane form is therefore particularly complex. The general objective of this research is to restore the angiogenic balance that maintains the physiological concentrations of free angiogenic factors in order to significantly prolong the pregnancy and diminish the consequences of the great prematurity. The precise objectives of the APHERESE 2 project are:

1. 1.To transpose the proof of concept of the APHERESE1 project to the scale of a real apheresis column
2. 2.To develop an innovative assay technology to determine the global circulating angiogenic balance for each patient

Conditions

Preeclampsia

Keywords

Preeclampsia; Apheresis; Angiogenic factors; Maternal biomarkers; sFLt-1; PIGF; Placenta; Pregnancy

Outcome Measures

Primary Outcomes (2)

• Concentration of total sFlt-1

  in pg/mL - to assess main angiogenic factors during PE, intra uterine growth restriction (IUGR) and normal pregnancy

  6 months

• Concentration of free PlGF

  in pg/mL - to assess main angiogenic factors during PE, intra uterine growth restriction (IUGR) and normal pregnancy

  6 months

Secondary Outcomes (3)

• Concentration of total PIGF

  6 months

• Concentration of total VEGFA

  6 months

• Concentration of total sVEGFR2

  6 months

Study Arms (3)

Preeclampsia

Pregnancy with preeclampsia

Biological: Biological collection

Pregnancies with intra uterine growth restriction (IUGR)

Pregnancy with intra uterine growth restriction (IUGR)

Biological: Biological collection

Normal pregnancy

Pregnancy without preeclampsia and intra uterine growth restriction (IUGR) and complications

Biological: Biological collection

Interventions

Biological collection BIOLOGICAL

A collection of maternal plasma, serum and urine

Normal pregnancy; Preeclampsia; Pregnancies with intra uterine growth restriction (IUGR)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnancy with preeclampsia or intra uterine growth restriction (IUGR) and without preeclampsia and intra uterine growth restriction (IUGR) and complications

You may qualify if:

• Age from 18 to 50 years old
• Singleton pregnancies between 20 and 41 weeks of gestation
• Preeclampsia / normal pregnancy

You may not qualify if:

• Age \< 18 years old
• Infectious disease: HIV, HBV or HCV
• Multiple pregnancies
• refusal to participate in the protocol
• Lack of social security cover

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Maternité Port-Royal

Paris, 75014, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, serum, plasma, urine

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Vassilis TSASARIS, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Edouard LECARPENTIER, MD, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY CHAIR

• Jean GUIBOURDENCHE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Vassilis TSASARIS, MD, PhD

CONTACT

+33 158413871; vassilis.tsasaris@aphp.fr

Charly LARRIEU

CONTACT

+33 1 58 41 34 78; charly.larrieu@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 18, 2024
• Study Start: February 10, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)