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Trial Outcomes & Findings for Losartan for Improved Vascular Endothelial Function After Preeclampsia (NCT NCT04632589)

NCT ID: NCT04632589

Last Updated: 2025-07-10

Results Overview

Cutaneous vascular vasodilator response to exogenous acetylcholine perfusion; measured with laser-Doppler flowmetry during intradermal microdialysis delivery of acetylcholine alone or co-infused with L-NAME. Cutaneous conductance is calculated (laser-Doppler flux/mean arterial pressure) and normalized to site specific maximal dilation (%maximum).

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

11 participants

Primary outcome timeframe

immediately following 6 weeks of oral treatment (losartan or placebo)

Results posted on

2025-07-10

Participant Flow

Participant milestones

Participant milestones
Measure
Losartan Than Placebo
6 weeks of daily (50mg/day) oral losartan potassium tablet followed by 14 day washout period then 6 weeks of daily oral placebo tablet. Losartan Potassium: subjects ingest 50mg losartan potassium tablet daily for 6 weeks Placebo: subjects ingest placebo tablet daily for 6 weeks
Placebo Than Losartan
6 weeks of daily oral placebo tablet followed by 14 day washout period then 6 weeks of daily oral placebo tablet. Placebo: subjects ingest placebo tablet daily for 6 weeks Losartan Potassium: subjects ingest 50mg losartan potassium tablet daily for 6 weeks
Overall Study
STARTED
6
5
Overall Study
COMPLETED
6
5
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Losartan for Improved Vascular Endothelial Function After Preeclampsia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=11 Participants
All participants were randomized to receive both interventions.
Age, Continuous
33 years
STANDARD_DEVIATION 6 • n=39 Participants
Sex: Female, Male
Female
11 Participants
n=39 Participants
Sex: Female, Male
Male
0 Participants
n=39 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=39 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
n=39 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=39 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=39 Participants
Race (NIH/OMB)
Asian
0 Participants
n=39 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=39 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=39 Participants
Race (NIH/OMB)
White
8 Participants
n=39 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=39 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=39 Participants
Region of Enrollment
United States
11 Participants
n=39 Participants

PRIMARY outcome

Timeframe: immediately following 6 weeks of oral treatment (losartan or placebo)

Population: All participants completed both treatments in randomized, blinded, cross-over design

Cutaneous vascular vasodilator response to exogenous acetylcholine perfusion; measured with laser-Doppler flowmetry during intradermal microdialysis delivery of acetylcholine alone or co-infused with L-NAME. Cutaneous conductance is calculated (laser-Doppler flux/mean arterial pressure) and normalized to site specific maximal dilation (%maximum).

Outcome measures

Outcome measures
Measure
Losartan
n=11 Participants
6 weeks of daily (50mg/day) oral losartan potassium tablet Losartan Potassium: subjects ingest 50mg losartan potassium tablet daily for 6 weeks
Placebo
n=11 Participants
6 weeks of daily oral placebo tablet Placebo: subjects ingest placebo tablet daily for 6 weeks
Cutaneous Conductance (%Maximum) Response to Acetylcholine
89.4 % of maximal cutaneous conductance
Standard Deviation 22.6
72.5 % of maximal cutaneous conductance
Standard Deviation 16.5

PRIMARY outcome

Timeframe: immediately following 6 weeks of oral treatment (losartan or placebo)

Population: all participants completed both treatments in randomized, blinded, cross-over design

Cutaneous vascular constrictor response to exogenous ang II perfusion; measured by laser-Doppler flowmetry during intradermal microdialysis delivery of angiotensin II. Cutaneous conductance is calculated (laser-Doppler flux/mean arterial pressure) and normalized to site-specific baseline conductance (%baseline) measured on the study day before the perfusion of angiotensin II.

Outcome measures

Outcome measures
Measure
Losartan
n=11 Participants
6 weeks of daily (50mg/day) oral losartan potassium tablet Losartan Potassium: subjects ingest 50mg losartan potassium tablet daily for 6 weeks
Placebo
n=11 Participants
6 weeks of daily oral placebo tablet Placebo: subjects ingest placebo tablet daily for 6 weeks
Cutaneous Conductance (%Baseline) Response to Angiotensin II
76.7 % of baseline cutaneous conductance
Standard Deviation 29.1
53.8 % of baseline cutaneous conductance
Standard Deviation 27.3

Adverse Events

Losartan

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anna Stanhewicz, PhD

University of Iowa

Phone: 3194671732

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place