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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04632589
Other study ID # 202006148
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date November 22, 2020
Est. completion date July 2025

Study information

Verified date September 2023
Source University of Iowa
Contact Anna Stanhewicz, PhD
Phone 319-467-1732
Email anna-stanhewicz@uiowa.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Women who develop preeclampsia during pregnancy are more likely to develop and die of 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 determine the mechanisms contributing to this lasting blood vessel damage and to test whether taking a medication that blocks angiotensin II receptors (losartan) decrease these negative effects in women who have had preeclampsia. Identification of these mechanisms and treatment strategies may lead to better clinical management,of cardiovascular disease risk in these women. In this study we use the blood vessels in the skin as a representative vascular bed. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickle-sized area of the skin in women who have had preeclampsia. We make these measurements after the subjects take a placebo and after they take losartan (an angiotensin II receptor blocker) to test whether this treatment improves vascular function in these women. As a compliment to these measurements, we also draw blood from the subjects and isolate the inflammatory cells to test how sensitive their inflammatory responses are following the placebo and the losartan treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date July 2025
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: Post-partum women, - 18 years or older, - who have delivered within 24 months of the study visit - who have had a preeclamptic pregnancy diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for preeclampsia. [This information will be self-reported by the subjects.] - Using an effective method of birth control and not planning to become pregnant in the next 6 months. Exclusion Criteria: - skin diseases, - current tobacco use, - diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR < 60 mL/min/1.73m2, - statin or other cholesterol-lowering medication, - current antihypertensive medication, - history of hypertension prior to pregnancy, - history of gestational diabetes, - current pregnancy or breastfeeding, - body mass index <18.5 kg/m2, - allergy to materials used during the experiment.(e.g. latex), - known allergies to study drugs.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Losartan Potassium
subjects ingest 50mg losartan potassium tablet daily for 6 weeks
Placebo
subjects ingest placebo tablet daily for 6 weeks

Locations

Country Name City State
United States University of Iowa Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
Anna Stanhewicz, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microvascular endothelial function following systemic AT1 receptor inhibition cutaneous vascular vasodilator response to exogenous acetylcholine perfusion; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of acetylcholine alone or co-infused with L-NAME at the completion of 6 weeks of oral losartan treatment
Primary Microvascular endothelial function following placebo cutaneous vascular vasodilator response to exogenous acetylcholine perfusion; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of acetylcholine alone or co-infused with L-NAME at the completion of 6 weeks of placebo treatment
Primary Microvascular angiotensin II sensitivity following systemic AT1 receptor inhibition cutaneous vascular constrictor response to exogenous ang II perfusion; measured by laser-Doppler flowmetry coupled with intradermal microdialysis delivery of angiotensin II at the completion of 6 weeks of oral losartan treatment, and 2) at the completion of 6 weeks of placebo treatment
Primary Microvascular angiotensin II sensitivity following placebo cutaneous vascular constrictor response to exogenous ang II perfusion; measured by laser-Doppler flowmetry coupled with intradermal microdialysis delivery of angiotensin II at the completion of 6 weeks of placebo treatment
Primary Central and Peripheral Vascular Stiffness following systemic AT1 receptor inhibition carotid-femoral and carotid-brachial Pulse Wave velocity; measured by applanation tonometry using the Sphygmocor pulse wave analysis system at the completion of 6 weeks of oral losartan treatment
Primary Central and Peripheral Vascular Stiffness following placebo carotid-femoral and carotid-brachial Pulse Wave velocity; measured by applanation tonometry using the Sphygmocor pulse wave analysis system at the completion of 6 weeks of placebo treatment
Secondary circulating inflammatory cytokines plasma measurement of circulating inflammatory cytokines; measured by ELISA in plasma samples a total of 2 times throughout the study: 1) at the completion of 6 weeks of oral losartan treatment, and 2) at the completion of 6 weeks of placebo treatment
Secondary PBMC inflammatory sensitivity isolated peripheral blood mononuclear cell inflammatory responses to ang II and LPS; measured by assessing inflammatory cytokines (ELISA) in cell culture supernatants collected from PBMCs treated with ang II or LPS for 24 hours a total of 2 times throughout the study: 1) at the completion of 6 weeks of oral losartan treatment, and 2) at the completion of 6 weeks of placebo treatment
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