Balance of Angiotensin II Receptors in Vessel Function After Preeclampsia

Preeclampsia Clinical Trial

Official title:

Balance of Angiotensin II Receptors in Vessel Function After Preeclampsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06157580
• Other study ID #: 202309383
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 1, 2023
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: University of Iowa
• Contact: Anna Reid-Stanhewicz, PHD
• Phone: 319-467-1732
• Email: anna-stanhewicz[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Otherwise healthy women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life. The reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during preeclampsia 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 differences in the microvascular balance of angiotensin II receptors women who have had preeclampsia. This will help the investigators better understand the mechanisms of dysregulated angiotensin II receptors in formerly preeclamptic women, and how activation or inhibition 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 or gestational hypertension
• 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 or >30 kg/m2
• allergy to materials used during the experiment.(e.g. latex),
• known allergy to study drugs

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Compound 21
differences in vasodilation to compound 21 in the skin between groups
• Angiotensin II
differences in vasoconstriction to angiotensin II in the skin between groups

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	Change in microvascular angiotensin II (ang II) type 2 receptor (AT2R)-mediated dilation response measured by laser-Doppler flowmetry	cutaneous vascular vasodilator responses to compound 21 perfusion in lactated Ringer's and losartan treated microdialysis sites	at the study visit, an average of 4 hours
Primary	Change in microvascular ang II-mediated constriction response measured by laser-Doppler flowmetry	cutaneous vascular vasoconstrictor responses to angiotensin II perfusion in lactated Ringer's and PD-123319 treated microdialysis sites	at the study visit, an average of 4 hours