Clinical trial NCT06912477: Endothelial Dysfunction for Prognosis In Patients With preeClampSia
Official title: Systematic Evaluation of Endothelial Dysfunction as a Prognostic Marker for Outcomes in Women With Preeclampsia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia (PE)
Hypertensive Disorder of Pregnancy
Keywords: preeclampsia
hyperspectral imaging
endothelial dysfunction
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 385
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are admitted to the Department of obstetrics at Heidelberg University Hospital

Brief summary: Preeclampsia is a pregnancy-specific hypertensive disorder and can progress rapidly to severe adverse outcomes affecting both the mother and the fetus. Endothelial and microcirculatory dysfunction mediate systemic preeclampsia-related organ dysfunctions. Changes in endothelial and vascular function in preeclampsia have been demonstrated through reduced flow-mediated vasodilation as a result of reduced availability of nitric oxide, which potentially persists up to several years postpartum. Hyperspectral imaging is a new innovative technology that allows to assess the peripheral microcirculation and perfusion non-invasively and contactless, but has never been evaluated in the context of preeclampsia before.

This EPICS project (Endothelial dysfunction for Prognosis In patients with preeClampSia) is a prospective observational study and aims to investigate hyperspectral imaging as a new potential diagnostic and prognostic marker in preeclampsia.

Detailed description: Preeclampsia is defined as hypertension combined with features of multi-organ dysfunction and can progress rapidly to severe adverse outcomes affecting both the mother and the fetus. Endothelial dysfunction is a key driver in the pathophysiology of preeclampsia mediating the systemic complications of this multi-organ disease. Changes in endothelial and vascular function in preeclampsia have been observed through reduced flow-mediated vasodilation, which occurs due to diminished nitric oxide availability and may persist for years after childbirth. Although symptoms of preeclampsia often resolve spontaneously after delivery, affected women will face a significantly increased risk of long-term cardiovascular complications. Thus, preeclampsia is viewed as an individual female-specific cardiovascular risk factor.

Beyond this background, hyperspectral imaging as an assessment of peripheral microcirculation and tissue perfusion appears to be a suitable method. Hyperspectral imaging is an innovative technique that visualizes hemodynamic changes by displaying the oxygen saturation of hemoglobin in the capillary system, the distribution of hemoglobin in the tissue, and the relative tissue water content. Hyperspectral imaging has not yet been studied in obstetrics or in the context of preeclampsia before. Given the well-documented microcirculatory disturbances associated with preeclampsia, the investigators hypothesize hyperspectral analysis as a valuable tool to bridge a diagnostic gap that might be useful to tailor individualized obstetric care of patients with preeclampsia.

Recently the "Endothelial Activation and Stress Index" (EASIX) was evaluated as prognostic marker in preeclampsia by the investigator group. EASIX is based on lactate dehydrogenase, platelets, and creatinine and was originally developed as simple score to predict endothelial-related complications after allogenic stem cell transplantation. However, the exact relationship of EASIX to endothelial cell biology and microcirculation requires further clarification. The investigators hypothesize that a reduced peripheral microcirculation will mediate direct interactions of platelets with endothelial cells, resulting in cellular damage (increased LDH), loss of platelets due to activation and microembolism, and lead to kidney damage.

The EPICS study (Endothelial dysfunction for Prognosis In patients with preeClampSia) is the first prospective study to investigate hyperspectral imaging in women with preeclampsia. The aim of this study is to evaluate whether and how changes in microcirculation in women with preeclampsia can be detected with hyperspectral imaging compared to women with pregnancy-induced hypertension, normotensive pregnant women and non-pregnant controls and whether microcirculatory perfusion quality is associated with other biochemical markers such as EASIX or markers of endothelial dysfunction. Furthermore, the EPICS study aims to evaluate the predictive performance of hyperspectral imaging with or without combination of other biochemical markers for adverse maternal and perinatal outcomes and the remaining time until delivery in patients with preeclampsia.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancies
* Age ≥ 18 years
* Patient's ability to provide consent
* written informed consent

Exclusion Criteria:

* Lack of consent
* Language barrier
* Dark to very dark skin type
* Severe fetal chromosomal/genetic/structural anomalies
* Laboratory changes in LDH, creatinine, or platelets due to other causes (e.g., isolated thrombocytopenia, e.g., immune thrombocytopenia, carcinoma)

Primary outcomes:
measure: Time Until Delivery
timeFrame: observation period until 6 months after delivery
Secondary outcomes:
measure: maternal adverse event
timeFrame: observation period until 6 months after delivery
measure: perinatal adverse event
timeFrame: observation period until 6 months after delivery
measure: maternal cardiovascular outcome: persistence of hypertension
timeFrame: observation period until 6 months after delivery
measure: maternal cardiovascular outcome: blood pressure
timeFrame: observation period until 6 months after delivery
measure: maternal cardiovascular outcome: antihypertensive medication
timeFrame: observation period until 6 months after delivery
measure: maternal cardiovascular outcome: readmission
timeFrame: observation period until 6 months after delivery
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital, Department of Gynecology and Obstetrics
Study officials:
affiliation: University Heidelberg
name: Dr. med. Alexandra von Au
role: PRINCIPAL_INVESTIGATOR
References: