Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy

Официальное название

Multiparametric Assessment of Maternal Vascular Function as a New Diagnostic and Prognostic Tool for Hypertensive Disorders of Pregnancy and Preeclampsia - EDIPE Study

Обзор

The present study is a single-centre prospective study that will enrol pregnant women during their first trimester of pregnancy (11+0 - 13+6 weeks of gestation). During pregnancy, women will undergo standard clinical evaluation and management. During the two study visits (enrollment and 24+0 - 27+6 weeks of gestation) the investigators will perform arterial tonometry (Pulsepen) and in vivo darkfield microscopy (Glycocheck) to evaluate endothelial and vascular function. A urine sample and a blood sample for specific study analyses on metabolic profile, endothelial and angiogenic markers will be collected. Pregnancy outcomes will be collected at delivery and five years after delivery all the participants will be interview to collect long-term cardiovascular outcomes. Serum endothelial and angiogenic markers will be evaluated only in participants who will develop hypertensive disorders of pregnancy and in an equal number of controls matched for age and body mass index at the time of conception.

Подробное описание

Primary aim:

To determine the role of the combination of arterial tonometry and endothelial glycocalyx measurement in predicting the risk of developing hypertensive disorders in pregnancy.

Secondary aims:

* To determine the association between circulating markers of angiogenesis and endothelial dysfunction (ANG-1, ANG-2, ET-1, ICAM-1 and VCAM-1) and the development of hypertensive disorders of pregnancy. * To define the trends of serum uric acid, lipids and xanthine oxidase activity in normotensive and hypertensive pregnancies. * To determine the ability of the combination of arterial tonometry and endothelial glycocalyx measurement, performed in the two study visits during pregnancy, in predicting the risk of long-term maternal cardiovascular disease.

Вмешательства

• Устройство Arterial applanation tonometry
  Arterial applanation tonometry will be performed at the carotid and femoral level by the PulsePen device (Software WPulsePen version 2.3.1, DiaTecne, Milan, Italy), while the subject is lying in the horizontal position and after 5 minutes of rest.
• Устройство In vivo endothelial glycocalyx measurement
  The in vivo microscopy (GlycoCheck system) is performed in the sublingual capillaries during the morning, with the participant sitting on a chair. The sublingual capillaries are visualized using an SDF video microscope (Capiscope handheld, KK Research technology Ltd).
• Диагностический тест Serum markers of angiogenesis and endothelial dysfunction
  ELISA assays to measure serum circulating markers of angiogenesis and endothelial dysfunction (ANG-1, ANG-2, ET-1, ICAM-1 and VCAM-1).
• Диагностический тест Blood chemistry test
  Immunochemistry analysis of serum levels of uric acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Lipoprotein (a)
• Диагностический тест Serum xanthine oxidase activity
  Serum xanthine oxidase (XO) activity will be assessed in blood samples measuring the ability of XO to produce uric acid

Первичные конечные точки

• Perfused Boundary Region (PBR) [Срок оценки: Baseline visit (11/13+6 weeks of pregnancy)]
• Perfused Boundary Region (PBR) [Срок оценки: Follow-up visit (24/27+6 weeks of pregnancy)]
• Carotid-femoral pulse wave velocity (cf-PWV) [Срок оценки: Baseline visit (11/13+6 weeks of pregnancy)]
• Carotid-femoral pulse wave velocity (cf-PWV) [Срок оценки: Follow-up visit (24/27+6 weeks of pregnancy)]
• Number of participants with hypertensive disorders of pregnancy [Срок оценки: From date of enrolment until the date of first documented diagnosis of hypertensive disorder of pregnancy, according to the International Society for the Study of Hypertension in Pregnancy Criteria, assessed up to one week after delivery]
• Number of participants with preeclampsia [Срок оценки: From date of enrolment until the date of first documented diagnosis of preeclampsia, according to the International Society for the Study of Hypertension in Pregnancy Criteria, assessed up to one week after delivery]

Вторичные конечные точки (11)

• Serum Angiopoietin 1 (ANG-1) [Срок оценки: Baseline visit (11/13+6 weeks of pregnancy)]
• Serum Angiopoietin 1 (ANG-1) [Срок оценки: Follow-up visit (24/27+6 weeks of pregnancy)]
• Serum Angiopoietin 2 (ANG-2) [Срок оценки: Baseline visit (11/13+6 weeks of pregnancy)]
• Serum Angiopoietin 2 (ANG-2) [Срок оценки: Follow-up visit (24/27+6 weeks of pregnancy)]
• Serum Endothelin-1 (ET-1) [Срок оценки: Baseline visit (11/13+6 weeks of pregnancy)]
• Serum Endothelin-1 (ET-1) [Срок оценки: Follow-up visit (24/27+6 weeks of pregnancy)]
• Serum Intercellular adhesion molecule-1 (ICAM-1) [Срок оценки: Baseline visit (11/13+6 weeks of pregnancy)]
• Serum Intercellular adhesion molecule-1 (ICAM-1) [Срок оценки: Follow-up visit (24/27+6 weeks of pregnancy)]
• Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) [Срок оценки: Baseline visit (11/13+6 weeks of pregnancy)]
• Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) [Срок оценки: Follow-up visit (24/27+6 weeks of pregnancy)]
• Number of participants with long-term cardiovascular outcomes [Срок оценки: Interview 5 years after delivery]

Критерии участия

Критерии включения

• Age greater than or equal to 18 years
• Single pregnancy
• No previous pregnancies lasting more than 12 weeks
• Participant willing and able to give informed consent for participation in the study

Критерии исключения

• Intermediate-high risk of genetic abnormalities and/or need to perform invasive tests (amniocentesis, villocentesis)
• History of solid organ or hematopoietic stem cell transplantation
• Chronic renal failure (eGFR≤45ml/min/1.73m2)
• Chronic treatment with antihypertensive drugs and/or xanthine oxidase (XO) inhibitors

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Италия · 1 центр

• Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Ital — Bologna

Идентификаторы

NCT: NCT05999851 · 346/2023/Oss/AOUBo

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗