PreeclampsiaEarly Phase 1NCT03482440
Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia
A Early Phase 1 study testing Salsalate Oral Tablet in people with Preeclampsia, run by University of Iowa at 2 sites in United States.
Trial summary
Women who develop preeclampsia during pregnancy are more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists… 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
- What is being tested?
- Salsalate Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Aug 2018to 31 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Post-partum women who have delivered within two years and who have had a preeclamptic pregnancy diagnosed by their obstetrician before 34 weeks of gestation and confirmed according to the American College of Obstetricians and Gynecologists criteria for severe preeclampsia. [This information will be self-reported by the subjects.]
- Post-partum women who have delivered within two years and who have had a normal pregnancy.
- 18 years and older.
Who cannot join
- skin diseases
- current tobacco use
- diagnosed or suspected hepatic or metabolic disease
- statin or other cholesterol-lowering medication
- history of hypertension prior to pregnancy
- history of gestational diabetes
Show all 12Show fewer
- current pregnancy
- allergy to aspirin or NSAIDs or known allergy to materials used during the experiment (e.g. latex)
- renal disease, bleeding disorders and history of gastrointestinal bleeding.
- Known allergies to study drugs
- Taking blood thinners, aspirin or NSAIDS.
- Women who choose to breastfeed will not participate in any parts of the project that include salsalate.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa
Iowa City, Iowa, 52242
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Role of Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclamptic Pregnancy
Women who develop preeclampsia during pregnancy are more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. The purpose of this investigation is to 1) determine the mechanisms contributing to this lasting blood vessel damage and chronic inflammation, and to 2) identify factors (both physiological and pharmacological) that mitigate these negative effects in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.
- Conditions
- Preeclampsia
- Being tested
- Salsalate Oral Tablet, Placebo Oral Tablet
- Keywords
- preeclampsia, microvascular, inflammation, angiotensin II
- Medical subject headings
- Pre-Eclampsia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salsalate Oral TabletDrug
1500mg twice daily for 4 days prior to experimental testing
Placebo Oral TabletDrug
Placebo oral table twice daily for 4 days prior to experimental testing
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
| Salsalate | Experimental | Not described Receives: Drug: Salsalate Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular Endothelial Function (Cutaneous Conductance, %Maximum)
Endothelium-dependent vasodilation assessed as cutaneous conductance response (cutaneous conductance = local red blood cell flux/mean arterial pressure; %maximum) to exogenous acetylcholine delivered via intradermal microdialysis.
Measured: immediately following the 4 days or oral treatment (salsalate or placebo)
Secondary outcomes (1)
Peripheral Blood Mononuclear Cell Inflammatory Response to Ang II
inflammatory cytokine (TNFalpha) release by peripheral blood mononuclear cells isolated from fresh whole blood collected via venipuncture and stimulated with angiotensin II ex vivo.
Measured: at the completion of 4 days of oral (placebo or salsalate) treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start26 Aug 2018
- Primary completion11 Jul 2019
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Principal investigator, Anna Stanhewicz, PhD, University of Iowa
- Investigators
- Anna Stanhewicz, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482440
- Sponsor's protocol ID
- 201909818
- Status last verified
- Jun 2025
- First submitted
- 15 Mar 2018
- Last updated
- 3 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclamptic Pregnancy
- ClinicalTrials.gov ID
- NCT03482440
- Acronym / sponsor ID
- 201909818
- Conditions
- Preeclampsia
- Keywords
- preeclampsia, microvascular, inflammation, angiotensin II
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- 26 Aug 2018 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 3 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women who develop preeclampsia during pregnancy are more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. The purpose of this investigation is to 1) determine the mechanisms contributing to this lasting blood vessel damage and chronic inflammation, and to 2) identify factors (both physiological and pharmacological) that mitigate these negative effects in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet |
| Salsalate | Experimental | Drug: Salsalate Oral Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post-partum women who have delivered within two years and who have had a preeclamptic pregnancy diagnosed by their obstetrician before 34 weeks of gestation and confirmed according to the American College of Obstetricians and Gynecologists criteria for severe preeclampsia. [This information will be self-reported by the subjects.]
- Post-partum women who have delivered within two years and who have had a normal pregnancy.
- 18 years and older.
Key exclusion criteria (12 listed)
- skin diseases
- current tobacco use
- diagnosed or suspected hepatic or metabolic disease
- statin or other cholesterol-lowering medication
- history of hypertension prior to pregnancy
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 |
|---|---|---|
| Salsalate Oral Tablet1500mg twice daily for 4 days prior to experimental testing | Drug | Salsalate |
| Placebo Oral TabletPlacebo oral table twice daily for 4 days prior to experimental testing | Drug | Placebo |
Primary outcome
Microvascular Endothelial Function (Cutaneous Conductance, %Maximum)
Time frame: immediately following the 4 days or oral treatment (salsalate or placebo)
Endothelium-dependent vasodilation assessed as cutaneous conductance response (cutaneous conductance = local red blood cell flux/mean arterial pressure; %maximum) to exogenous acetylcholine delivered via intradermal microdialysis.
1 secondary outcome
Peripheral Blood Mononuclear Cell Inflammatory Response to Ang II
Time frame: at the completion of 4 days of oral (placebo or salsalate) treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No individual participant data will be shared
Related trials for Preeclampsia
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Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
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Daily Aspirin Treatment After Preeclampsia
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Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
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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. This study is not recruiting at the moment.
Anna Stanhewicz, PhD principal investigator
University of Iowa
2 sites 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 Salsalate Oral Tablet in people with Preeclampsia, run by University of Iowa at 2 sites 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 12 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: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Microvascular Endothelial Function (Cutaneous Conductance, %Maximum) (time frame: immediately following the 4 days or oral treatment (salsalate or placebo)). 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 3 Jun 2025.