Preeclampsia (PE)EPICSNCT06912477
Endothelial Dysfunction for Prognosis In Patients With preeClampSia
An observational study of Preeclampsia (PE) and Hypertensive Disorder of Pregnancy, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia (PE), Hypertensive Disorder of Pregnancy
- What is being tested?
- Hyperspectral imaging and Further markers of endothelial dysfunction
- How many people
- 385 participants
- Where
- 1 siteGermany
- Study dates
- 8 May 2025to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are admitted to the Department of obstetrics at Heidelberg University Hospital
Who may be able to join
- singleton pregnancies
- Age ≥ 18 years
- Patient's ability to provide consent
- written informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Heidelberg University Hospital, Department of Gynecology and Obstetrics
Heidelberg, 69120
Dr. med. Anna Scholz, +49 6221 56 32080, anna.scholz@med.uni-heidelberg.de
Alexandra von Au, Dr. med., alexandra.vonau@med.uni-heidelberg.de
About this study
Official title: Systematic Evaluation of Endothelial Dysfunction as a Prognostic Marker for Outcomes in Women With Preeclampsia
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.
Read the 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.
- Being tested
- Hyperspectral imaging, Further markers of endothelial dysfunction
- Keywords
- preeclampsia, hyperspectral imaging, endothelial dysfunction
- Medical subject headings
- Pre-Eclampsia, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperspectral imagingDiagnostic test
Hyperspectral imaging will be performed at study inclusion and will be repeated longitudinally every 1-2 days until delivery and on the first and second day after delivery. After a baseline measurement, a blood pressure cuff is inflated on the upper arm to 50 mmHg above the systolic blood pressure for 5 minutes, and then the hyperspectral imaging measurement is repeated.
Blood samples are collected at study inclusion and on the first and second day after delivery and are processed within the Department of Gynecology and Obstetrics of the Heidelberg University Hospital.
Further markers of endothelial dysfunctionDiagnostic test
At study inclusion: 1. blood samples will be collected for the measurement of EASIX and cardiac/endothelial markers; 2. sublingual in vivo microscopy will be performed (requires about 20 minutes and can be compared to a sublingual temperature measurement); 3. Doppler ultrasound will be performed to evaluate uterine and ophthalmic arteries.
Blood samples will also be collected at the first and second day after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Preeclampsia | patients with diagnosis of preeclampsia according to definitions by the International Society for the Study of Hypertension in Pregnancy (n=110) Receives: Diagnostic Test: Hyperspectral imaging; Diagnostic Test: Further markers of endothelial dysfunction | |
| Pregnancy induced Hypertension and chronic Hypertension | patients with hypertension in pregnancy without fulfilling criteria of preeclampsia (n=110) Receives: Diagnostic Test: Hyperspectral imaging; Diagnostic Test: Further markers of endothelial dysfunction | |
| Normotensive pregnant control group | normotensive pregnancies (n=110) Receives: Diagnostic Test: Hyperspectral imaging; Diagnostic Test: Further markers of endothelial dysfunction | |
| Non-pregnant control group | normotensive, non-pregnant women (n=55) Receives: Diagnostic Test: Hyperspectral imaging; Diagnostic Test: Further markers of endothelial dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Until Delivery
Time period between date of study inclusion (diagnostic tests) to delivery
Measured: observation period until 6 months after delivery
Secondary outcomes (6)
maternal adverse event
composite adverse maternal outcome (categorical, yes/no): death, acute kidney injury, cardiorespiratory complication (e.g. pulmonary edema), eclampsia, cerebrovascular event, hematological complication, hepatic complication, postpartum hemorrhage, the Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome, placental abruption
Measured: observation period until 6 months after delivery
perinatal adverse event
composite perinatal endpoint (categorical, yes/no): neonatal mortality, stillbirth, preeclampsia-related preterm delivery, respiratory distress syndrome, neonatal seizures, intraventricular hemorrhage, necrotizing enterocolitis, birthweight <10th percentile, admission to neonatal unit, respiratory support
Measured: observation period until 6 months after delivery
maternal cardiovascular outcome: persistence of hypertension
number of participants with persisting hypertension
Measured: observation period until 6 months after delivery
maternal cardiovascular outcome: blood pressure
blood pressure (mmHg)
Measured: observation period until 6 months after delivery
maternal cardiovascular outcome: antihypertensive medication
number of participants who required antihypertensive medication initiation or dose adjustment
Measured: observation period until 6 months after delivery
maternal cardiovascular outcome: readmission
number of participants who required readmission for hypertension
Measured: observation period until 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start8 May 2025
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia (PE)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Scholz, Heidelberg University
- Investigators
- Dr. med. Alexandra von Au, Principal investigator, University Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912477
- Sponsor's protocol ID
- S-457/2024
- Acronym
- EPICS
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Evaluation of Endothelial Dysfunction as a Prognostic Marker for Outcomes in Women With Preeclampsia
- ClinicalTrials.gov ID
- NCT06912477
- Acronym / sponsor ID
- EPICS / S-457/2024
- Keywords
- preeclampsia, hyperspectral imaging, endothelial dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 4 Apr 2025 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia | – | Diagnostic Test: Hyperspectral imaging, Diagnostic Test: Further markers of endothelial dysfunctionpatients with diagnosis of preeclampsia according to definitions by the International Society for the Study of Hypertension in Pregnancy (n=110) |
| Pregnancy induced Hypertension and chronic Hypertension | – | Diagnostic Test: Hyperspectral imaging, Diagnostic Test: Further markers of endothelial dysfunctionpatients with hypertension in pregnancy without fulfilling criteria of preeclampsia (n=110) |
| Normotensive pregnant control group | – | Diagnostic Test: Hyperspectral imaging, Diagnostic Test: Further markers of endothelial dysfunctionnormotensive pregnancies (n=110) |
| Non-pregnant control group | – | Diagnostic Test: Hyperspectral imaging, Diagnostic Test: Further markers of endothelial dysfunctionnormotensive, non-pregnant women (n=55) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are admitted to the Department of obstetrics at Heidelberg University Hospital
Key inclusion criteria (4 listed)
- singleton pregnancies
- Age ≥ 18 years
- Patient's ability to provide consent
- written informed consent
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Hyperspectral imagingHyperspectral imaging will be performed at study inclusion and will be repeated longitudinally every 1-2 days until delivery and on the first and second day after delivery. After a baseline measurement, a blood pressure cuff is inflated on the upper arm to 50 mmHg above the systolic blood pressure for 5 minutes, and then the hyperspectral imaging measurement is repeated. Blood samples are collected at study inclusion and on the first and second day after delivery and are processed within the Department of Gynecology and Obstetrics of the Heidelberg University Hospital. | Diagnostic test | Non-pregnant control group, Normotensive pregnant control group, Preeclampsia, Pregnancy induced Hypertension and chronic Hypertension |
| Further markers of endothelial dysfunctionAt study inclusion: 1. blood samples will be collected for the measurement of EASIX and cardiac/endothelial markers; 2. sublingual in vivo microscopy will be performed (requires about 20 minutes and can be compared to a sublingual temperature measurement); 3. Doppler ultrasound will be performed to evaluate uterine and ophthalmic arteries. Blood samples will also be collected at the first and second day after delivery. | Diagnostic test | Non-pregnant control group, Normotensive pregnant control group, Preeclampsia, Pregnancy induced Hypertension and chronic Hypertension |
Primary outcome
Time Until Delivery
Time frame: observation period until 6 months after delivery
Time period between date of study inclusion (diagnostic tests) to delivery
6 secondary outcomes
maternal adverse event
Time frame: observation period until 6 months after delivery
perinatal adverse event
Time frame: observation period until 6 months after delivery
maternal cardiovascular outcome: persistence of hypertension
Time frame: observation period until 6 months after delivery
maternal cardiovascular outcome: blood pressure
Time frame: observation period until 6 months after delivery
maternal cardiovascular outcome: antihypertensive medication
Time frame: observation period until 6 months after delivery
maternal cardiovascular outcome: readmission
Time frame: observation period until 6 months after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Dr. med. Alexandra von Au principal investigator
University Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia (PE) and Hypertensive Disorder of Pregnancy, run by Heidelberg University at 1 site in Germany.
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 5 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. med. Anna Scholz (+49 6221 56 32080, anna.scholz@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Until Delivery (time frame: observation period until 6 months after delivery). 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 4 Sep 2026.