Trial Outcomes & Findings for Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia (NCT NCT03482440)

Last Updated: 2025-06-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

24 participants

Primary outcome timeframe

immediately following the 4 days or oral treatment (salsalate or placebo)

Results posted on

2025-06-03

Participant Flow

this is a crossover study design - all participants (23 total) completed each arm of the study in a randomized placebo controlled study design

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	13	10
Overall Study COMPLETED	13	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=23 Participants All participants were randomized to received both interventions.
Age, Continuous	30 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: immediately following the 4 days or oral treatment (salsalate or placebo)

Outcome measures

Outcome measures
Measure	Oral Salsalate n=23 Participants Participants first received 4 days oral salsalate tablet 1500mg twice daily.	Oral Placebo n=23 Participants Participants first received 4 days of placebo treatment twice daily.
Microvascular Endothelial Function (Cutaneous Conductance, %Maximum)	95 % of maximal cutaneous conductance Standard Deviation 6	77 % of maximal cutaneous conductance Standard Deviation 8

SECONDARY outcome

Timeframe: at the completion of 4 days of oral (placebo or salsalate) treatment

inflammatory cytokine (TNFalpha) release by peripheral blood mononuclear cells isolated from fresh whole blood collected via venipuncture and stimulated with angiotensin II ex vivo.

Outcome measures

Outcome measures
Measure	Oral Salsalate n=23 Participants Participants first received 4 days oral salsalate tablet 1500mg twice daily.	Oral Placebo n=23 Participants Participants first received 4 days of placebo treatment twice daily.
Peripheral Blood Mononuclear Cell Inflammatory Response to Ang II	2.37 ng/ml Standard Deviation 1.28	2.77 ng/ml Standard Deviation 1.01

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Salsalate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=23 participants at risk Placebo oral table twice daily for 4 days prior to experimental testing.	Salsalate n=23 participants at risk Salsalate Oral Tablet 1500mg twice daily for 4 days prior to experimental testing.
Ear and labyrinth disorders tennitis while on salsalate	0.00% 0/23 • Adverse event data were collected on day 2 and day 4 of the 4 day treatment periods.	8.7% 2/23 • Number of events 2 • Adverse event data were collected on day 2 and day 4 of the 4 day treatment periods.

Additional Information

Anna Stanhewicz

University of Iowa

Phone: 3194671732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place