PreeclampsiaEarly Phase 1NCT07345845
MR and Inflammation After Preeclampsia
A Early Phase 1 study testing Eplerenone in people with Preeclampsia and Preeclampsia Postpartum, run by Anna Stanhewicz, PhD at 1 site in United States.
Trial summary
The purpose of this investigation is to examine the role of inappropriate mineralocorticoid receptor activation in endothelial dysfunction and vascular inflammation in otherwise healthy women with a history of preeclampsia. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Preeclampsia Postpartum
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2025to 1 Feb 2029
- Phase
- Early Phase 1
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women who had preeclampsia and women who did not have preeclampsia
- 12 weeks to 5 years postpartum
- 18-45 years old
Who cannot join
- history of hypertension or metabolic disease before pregnancy
- history of gestational diabetes
- history of gestational hypertension without preeclampsia
- skin diseases
- current tobacco use
- current antihypertensive medication
Show all 11Show fewer
- statin or other cholesterol-lowering medication
- currently pregnant
- body mass index less than 18.5 kg/m2
- allergy to materials used during the experiment.(e.g. latex),
- known allergy to study drugs or salt-supplement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of Mineralocorticoid Receptor Signaling to Vascular Dysfunction & Aberrant Inflammation After Preeclampsia
The purpose of this investigation is to examine the role of inappropriate mineralocorticoid receptor activation in endothelial dysfunction and vascular inflammation in otherwise healthy women with a history of preeclampsia. The main questions it aims to answer are:
- Does overactivation of the mineralocorticoid receptor contribute to reduced endothelial function in women who had preeclampsia?
- To what extent does the mineralocorticoid receptor mediated exaggerated production of inflammatory cytokines in immune cells from women who had preeclampsia?
Read more
Participants will visit the research laboratory for 2 experimental visits:
- Visit 1: Skin blood flow will be measured using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) to examine blood vessels in a nickel-sized area of the skin.
- Visit 2: Endothelial cells will be collected from an antecubital vein.
- Conditions
- Preeclampsia, Preeclampsia Postpartum
- Being tested
- Eplerenone
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Local heating: eplerenone is locally and acutely delivered to the cutaneous microvasculature during local heating of the skin to assess endothelium-dependent dilation, L-NAME is added to assess nitric oxide-dependent dilation during this response
| Study group | Role | What they receive |
|---|---|---|
| Assessment of microvascular function | Experimental | The investigators use intradermal microdialysis to deliver eplerenone and L-NAME to the cutaneous microvasculature Receives: Drug: Eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microvascular endothelial function following local eplerenone treatment compared to placebo treatment measured by laser-Doppler flowmetry
Cutaneous vascular vasodilator response (cutaneous conductance; %max) to local heating of the skin; intradermal microdialysis for the local delivery of eplerenone compared to control (Ringer's solution), followed by L-NAME infusion to quantify NO-dependent response
Measured: post 1 hour of skin perfusion
Secondary outcomes (2)
Mineralocorticoid receptor expression in endothelial cells
The investigators will quantify expression of the mineralocorticoid receptor in biopsied endothelial cells.
Measured: a total of 1 time during the study, within ~4 weeks following enrollment
Inflammatory response from isolated immune cells
The investigators will measure inflammatory responses, assessed as inflammatory cytokine release following activation of immune cells in the presence and absence of eplerenone treatment. Cells are collected from a blood draw and treated with eplerenone in a cell culture environment (ex vivo treatment).
Measured: from a blood draw collected at the start of the experimental visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start17 Dec 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Stanhewicz, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Stanhewicz, PhD, University of Iowa
- Investigators
- Anna Reid-Stanhewicz, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345845
- Sponsor's protocol ID
- 202508378
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Mineralocorticoid Receptor Signaling to Vascular Dysfunction & Aberrant Inflammation After Preeclampsia
- ClinicalTrials.gov ID
- NCT07345845
- Acronym / sponsor ID
- 202508378
- Conditions
- Preeclampsia, Preeclampsia Postpartum
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anna Stanhewicz, PhDUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 16 Jan 2026 (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.
The purpose of this investigation is to examine the role of inappropriate mineralocorticoid receptor activation in endothelial dysfunction and vascular inflammation in otherwise healthy women with a history of preeclampsia. The main questions it aims to answer are:
- Does overactivation of the mineralocorticoid receptor contribute to reduced endothelial function in women who had preeclampsia?
- To what extent does the mineralocorticoid receptor mediated exaggerated production of inflammatory cytokines in immune cells from women who had preeclampsia?
Participants will visit the research laboratory for 2 experimental visits:
- Visit 1: Skin blood flow will be measured using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) to examine blood vessels in a nickel-sized area of the skin.
- Visit 2: Endothelial cells will be collected from an antecubital vein.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment of microvascular function | Experimental | Drug: EplerenoneThe investigators use intradermal microdialysis to deliver eplerenone and L-NAME to the cutaneous microvasculature |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women who had preeclampsia and women who did not have preeclampsia
- 12 weeks to 5 years postpartum
- 18-45 years old
Key exclusion criteria (11 listed)
- history of hypertension or metabolic disease before pregnancy
- history of gestational diabetes
- history of gestational hypertension without preeclampsia
- skin diseases
- current tobacco use
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 |
|---|---|---|
| EplerenoneLocal heating: eplerenone is locally and acutely delivered to the cutaneous microvasculature during local heating of the skin to assess endothelium-dependent dilation, L-NAME is added to assess nitric oxide-dependent dilation during this response | Drug | Assessment of microvascular function |
Primary outcome
Change in microvascular endothelial function following local eplerenone treatment compared to placebo treatment measured by laser-Doppler flowmetry
Time frame: post 1 hour of skin perfusion
Cutaneous vascular vasodilator response (cutaneous conductance; %max) to local heating of the skin; intradermal microdialysis for the local delivery of eplerenone compared to control (Ringer's solution), followed by L-NAME infusion to quantify NO-dependent response
2 secondary outcomes
Mineralocorticoid receptor expression in endothelial cells
Time frame: a total of 1 time during the study, within ~4 weeks following enrollment
Inflammatory response from isolated immune cells
Time frame: from a blood draw collected at the start of the experimental visit
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 16 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
RecruitingPhase 4
AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Hypertensive Disorders of Pregnancy, Preeclampsia
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
RecruitingPhase 2
Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
Preeclampsia
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. This study is not recruiting at the moment.
Anna Reid-Stanhewicz, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Eplerenone in people with Preeclampsia and Preeclampsia Postpartum, run by Anna Stanhewicz, PhD at 1 site in United States.
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 3 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microvascular endothelial function following local eplerenone treatment compared to placebo treatment measured by laser-Doppler flowmetry (time frame: post 1 hour of skin perfusion). 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 16 Jan 2026.