An Early Phase 1 interventional study of Salsalate Oral Tablet and Placebo Oral Tablet in Preeclampsia, sponsored by University of Iowa. Completed at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by University of Iowa · Early Phase 1, Interventional, and Basic science
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.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's enrollment of 24 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →University of Iowa is the lead sponsor of 279 studies on the registry; 33 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 40 (89%) have results posted.
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Exclusion Criteria:
Drug: Placebo Oral Tablet
Drug: Salsalate Oral Tablet
1500mg twice daily for 4 days prior to experimental testing
Placebo oral table twice daily for 4 days prior to experimental testing
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.
Time frame: immediately following the 4 days or oral treatment (salsalate or placebo)
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.
Time frame: at the completion of 4 days of oral (placebo or salsalate) treatment
| Milestone | Placebo Then Salsalate | Salsalate Then Placebo |
|---|---|---|
| Started | 13 | 10 |
| Completed | 13 | 10 |
| Not completed | 0 | 0 |
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.
| % of maximal cutaneous conductance | Oral Salsalate | Oral Placebo |
|---|---|---|
| Microvascular Endothelial Function (Cutaneous Conductance, %Maximum) | 95 ± 6 | 77 ± 8 |
inflammatory cytokine (TNFalpha) release by peripheral blood mononuclear cells isolated from fresh whole blood collected via venipuncture and stimulated with angiotensin II ex vivo.
| ng/ml | Oral Salsalate | Oral Placebo |
|---|---|---|
| Peripheral Blood Mononuclear Cell Inflammatory Response to Ang II | 2.37 ± 1.28 | 2.77 ± 1.01 |
Collected over Adverse event data were collected on day 2 and day 4 of the 4 day treatment periods.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Salsalate | 0/23 (0%) | 0/23 (0%) | 2/23 (8.7%) |
| Event | Placebo | Salsalate |
|---|---|---|
| tennitis while on salsalateEar and labyrinth disorders | 0/23 | 2/23 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 30 ± 5 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 23 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 22 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No individual participant data will be shared
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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