PreeclampsiaEarly Phase 1NCT06157580
Balance of Angiotensin II Receptors in Vessel Function After Preeclampsia
A Early Phase 1 study testing Compound 21 and Angiotensin II in people with Preeclampsia, run by Anna Stanhewicz, PhD at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Compound 21 and Angiotensin II
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2023to 10 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women who had preeclampsia and women who did not have preeclampsia
- 12 weeks to 5 years postpartum
- 18-45 years old
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Preeclampsia
- Being tested
- Compound 21, Angiotensin II
- Keywords
- postpartum, vascular
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound 21Drug
differences in vasodilation to compound 21 in the skin between groups
Angiotensin IIDrug
differences in vasoconstriction to angiotensin II in the skin between groups
| Study group | Role | What they receive |
|---|---|---|
| History of a preeclampsia | Other | Women who had preeclampsia in their most recent pregnancy Receives: Drug: Compound 21; Drug: Angiotensin II |
| History of a healthy pregnancy | Other | Women who had an uncomplicated pregnancy Receives: Drug: Compound 21; Drug: Angiotensin II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the study visit, an average of 4 hours
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
Measured: at the study visit, an average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start8 Dec 2023
- Primary completion24 Oct 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Stanhewicz, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Stanhewicz, PhD, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157580
- Sponsor's protocol ID
- 202309383
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2023
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance of Angiotensin II Receptors in Vessel Function After Preeclampsia
- ClinicalTrials.gov ID
- NCT06157580
- Acronym / sponsor ID
- 202309383
- Conditions
- Preeclampsia
- Keywords
- postpartum, vascular
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Anna Stanhewicz, PhDUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| History of a preeclampsia | Other | Drug: Compound 21, Drug: Angiotensin IIWomen who had preeclampsia in their most recent pregnancy |
| History of a healthy pregnancy | Other | Drug: Compound 21, Drug: Angiotensin IIWomen who had an uncomplicated pregnancy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women who had preeclampsia and women who did not have preeclampsia
- 12 weeks to 5 years postpartum
- 18-45 years old
Key exclusion criteria (10 listed)
- history of hypertension or metabolic disease before pregnancy
- history of gestational diabetes or gestational hypertension
- skin diseases
- current tobacco use
- current antihypertensive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound 21differences in vasodilation to compound 21 in the skin between groups | Drug | History of a healthy pregnancy, History of a preeclampsia |
| Angiotensin IIdifferences in vasoconstriction to angiotensin II in the skin between groups | Drug | History of a healthy pregnancy, History of a preeclampsia |
Primary outcome
Change in microvascular angiotensin II (ang II) type 2 receptor (AT2R)-mediated dilation response measured by laser-Doppler flowmetry
Time frame: at the study visit, an average of 4 hours
cutaneous vascular vasodilator responses to compound 21 perfusion in lactated Ringer's and losartan treated microdialysis sites
Change in microvascular ang II-mediated constriction response measured by laser-Doppler flowmetry
Time frame: at the study visit, an average of 4 hours
cutaneous vascular vasoconstrictor responses to angiotensin II perfusion in lactated Ringer's and PD-123319 treated microdialysis sites
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Compound 21 and Angiotensin II in people with Preeclampsia, run by Anna Stanhewicz, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microvascular angiotensin II (ang II) type 2 receptor (AT2R)-mediated dilation response measured by laser-Doppler flowmetry (time frame: at the study visit, an average of 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.