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Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia

Primary Purpose

Preeclampsia Postpartum

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Compound 21
Sponsored by
Anna Stanhewicz, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Preeclampsia Postpartum

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: women who had preeclampsia and women who did not have preeclampsia 12 weeks to 5 years postpartum 18-45 years old Exclusion Criteria: history of hypertension or metabolic disease before pregnancy history of gestational diabetes skin diseases current tobacco use current antihypertensive medication statin or other cholesterol-lowering medication currently pregnant or planning to become pregnant body mass index less than 18.5 kg/m2 allergy to materials used during the experiment.(e.g. latex), known allergy to study drugs

Sites / Locations

  • University of IowaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

assessment of microvascular function

Arm Description

The investigators use intradermal microdialysis to deliver compound 21 and L-NAME to the cutaneous microvasculature

Outcomes

Primary Outcome Measures

Change in microvascular blood flow response to local compound 21 treatment measured by laser-Doppler flowmetry
Cutaneous vascular vasodilator response (cutaneous conductance; %max) to exogenous compound 21 perfusion; intradermal microdialysis for the local delivery of compound 21
Change in microvascular endothelial function following local C21 treatment compared to placebo treatment measured by laser-Doppler flowmetry
Cutaneous vascular vasodilator response (cutaneous conductance; %max) to local heating of the skin; intradermal microdialysis for the local delivery of compound 21 compared to control (Ringer's solution), followed by L-NAME infusion to quantify NO-dependent response

Secondary Outcome Measures

Angiotensin receptor expression in endothelial cells
Quantify expression of angiotensin II receptor expression in biopsied endothelial cells

Full Information

First Posted
June 21, 2023
Last Updated
July 7, 2023
Sponsor
Anna Stanhewicz, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT05937841
Brief Title
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
Official Title
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Stanhewicz, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 impaired endothelial function and dysregulation of the angiotensin system that occurs during the preeclamptic pregnancy and persists postpartum, despite the remission of clinical symptoms. The purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage caused by reduced endothelial function in women who have had preeclampsia compared to women who had a healthy pregnancy. Identification of these mechanisms and treatment strategies may lead to better clinical management of cardiovascular disease risk in these women. The purpose of this study is to examine the microvascular differences in women who have had preeclampsia following activation of protective angiotensin receptors in the skin. This will help increase understanding of the mechanisms of angiotensin II receptors in these women, and how activation of these receptors may restore microvascular function. In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) the investigators examine the blood vessels in a dime-sized area of the skin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia Postpartum

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
assessment of microvascular function
Arm Type
Experimental
Arm Description
The investigators use intradermal microdialysis to deliver compound 21 and L-NAME to the cutaneous microvasculature
Intervention Type
Drug
Intervention Name(s)
Compound 21
Intervention Description
AT2R sensitivity: compound 21, and compound 21+ L-NAME (nitric oxide synthase inhibitor) are locally and acutely delivered to the cutaneous microvasculature to assess AT2R-mediated dilation and role of nitric oxide in this response Local heating: compound 21 is locally and acutely delivered to the cutaneous microvasculature during local heating of the skin to assess endothelium-dependent dilation, L-NAME is added to assess nitric oxide-dependent dilation during this response
Primary Outcome Measure Information:
Title
Change in microvascular blood flow response to local compound 21 treatment measured by laser-Doppler flowmetry
Description
Cutaneous vascular vasodilator response (cutaneous conductance; %max) to exogenous compound 21 perfusion; intradermal microdialysis for the local delivery of compound 21
Time Frame
post 1 hour of skin perfusion
Title
Change in microvascular endothelial function following local C21 treatment compared to placebo treatment measured by laser-Doppler flowmetry
Description
Cutaneous vascular vasodilator response (cutaneous conductance; %max) to local heating of the skin; intradermal microdialysis for the local delivery of compound 21 compared to control (Ringer's solution), followed by L-NAME infusion to quantify NO-dependent response
Time Frame
post 1 hour of skin perfusion
Secondary Outcome Measure Information:
Title
Angiotensin receptor expression in endothelial cells
Description
Quantify expression of angiotensin II receptor expression in biopsied endothelial cells
Time Frame
a total of 1 time during the study, within ~4 weeks following enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women who had preeclampsia and women who did not have preeclampsia 12 weeks to 5 years postpartum 18-45 years old Exclusion Criteria: history of hypertension or metabolic disease before pregnancy history of gestational diabetes skin diseases current tobacco use current antihypertensive medication statin or other cholesterol-lowering medication currently pregnant or planning to become pregnant body mass index less than 18.5 kg/m2 allergy to materials used during the experiment.(e.g. latex), known allergy to study drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelsey Schwartz
Phone
319-467-3096
Email
kelsey-schwartz@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Reid-Stanhewicz, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Schwartz
Phone
319-467-3096
Email
kelsey-schwartz@uiowa.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia

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