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| Name | Class |
|---|---|
| Penn State University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Salsalate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salsalate Oral Tablet | Drug | 1500mg twice daily for 4 days prior to experimental testing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately following the 4 days or oral treatment (salsalate or placebo) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at the completion of 4 days of oral (placebo or salsalate) treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Stanhewicz, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States | ||
| Pennsylvania State University |
No individual participant data will be shared
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this is a crossover study design - all participants (23 total) completed each arm of the study in a randomized placebo controlled study design
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Salsalate | Placebo oral table twice daily for 4 days prior to experimental testing followed by 14 day washout period and then salsalate oral tablet 1500mg twice daily for 4 days prior to experimental testing |
| FG001 | Salsalate Then Placebo | Salsalate Oral Tablet 1500mg twice daily for 4 days prior to experimental testing followed by 14 day washout period and then placebo oral tablet twice daily for 4 days prior to experimental testing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants were randomized to received both interventions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | % of maximal cutaneous conductance | immediately following the 4 days or oral treatment (salsalate or placebo) |
|
Adverse event data were collected on day 2 and day 4 of the 4 day treatment periods.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo oral table twice daily for 4 days prior to experimental testing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tennitis while on salsalate | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Stanhewicz | University of Iowa | 3194671732 | anna-stanhewicz@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2020 | Mar 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 24, 2020 | Mar 27, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C014182 | salicylsalicylic acid |
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| Placebo Oral Tablet |
| Drug |
Placebo oral table twice daily for 4 days prior to experimental testing |
|
| University Park |
| Pennsylvania |
| 16802 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/ml | at the completion of 4 days of oral (placebo or salsalate) treatment |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Salsalate | Salsalate Oral Tablet 1500mg twice daily for 4 days prior to experimental testing. | 0 | 23 | 0 | 23 | 2 | 23 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |