Pre-EclampsiaPAVANCT04484766
Preeclampsia Associated Vascular Aging
An observational study of Pre-Eclampsia, run by Jena University Hospital at 1 site in Germany.
Trial summary
To evaluate cardiovascular health, especially endothelial health, of women after pre-eclampsia compared to women without pre-eclampsia, and to compare women who had taken PETN during pregnancy with women who had not attempted treatment Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Primary data collection
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2019to 30 Jun 2023
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pre-eclampsia 10 to 20 years ago. The patients are matched with the next consenting patient who gave birth without pregnancy complications. Only singleton pregnancies born between the 24th and 42nd week of pregnancy are considered. Patients with and without PETN treatment are recruited from the patients who participated in the PETN pilot study from 2002 to 2008. In addition, patients are recruited who received PETN treatment as a personalised therapy trial. These are matched by patients without treatment. The matching includes the indication for treatment, the week of pregnancy at diagnosis and the percentiles of fetal growth
Who may be able to join
- Participants of the PETN pilot study from 2002-2008
- controls: uneventful pregnancies from 2002-2008
- Patients with pre-eclampsia with PETN treatment 10-20 years ago
- Controls: patients with pre-eclampsia without PETN treatment 10-20 years ago
- Written Informed Consent
- Singleton pregnancy
Who cannot join
- Patients who refuse to participate in the study
- Impossibility of the outpatient presentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preeclampsia Associated Vascular Age- Long-term Follow-up and New Prevention Strategy
To evaluate cardiovascular health, especially endothelial health, of women after pre-eclampsia compared to women without pre-eclampsia, and to compare women who had taken PETN during pregnancy with women who had not attempted treatment
Read the detailed description
The clinical observation that women with pre-eclampsia have a high risk of early onset cardiovascular disease with increased disease-associated mortality has led to the hypothesis that the endothelial status of these women is characterized by early onset of aging. We want to investigate the relationship between endothelial aging and pregnancy disorders such as pre-eclampsia, which are dominated by endothelial dysfunction. Do endothelial changes precede pregnancy and cause pre-eclampsia and later accelerated cardiovascular aging, or does pre-eclampsia trigger premature endothelial aging in affected individuals for the first time? The aim of this study is to investigate the cardiovascular health of women 10 to 20 years after pre-eclampsia and to compare it with that of women with uneventful pregnancies. In addition, the potential long-term endothelial protective effect of the NO-donor pentaerithrityltetranitrate (PETN) is investigated.
This in vivo study will be extended in vitro by the analysis of senescence induction in endothelial cells after pre-eclampsia associated stress. Additionally, the potential protective effect of PETN on stress-induced senescence will be evaluated.
The ultimate goal is to establish a prospective long-term study on the effect of PETN on vascular health in women with pre-eclampsia to assess whether treatment of endothelial dysfunction during pregnancy could reduce endothelial aging and thus premature cardiovascular morbidity and mortality in millions of women.
- Conditions
- Pre-Eclampsia
- Being tested
- Primary data collection
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary data collectionOther
Also called Physical examination, Cardiac measurement, Vascular Measurement, Serum analysis
Primary data collection takes place via questionnaires outside the study centre.
All other investigations take place at the study centre:
- Physical examination: height, weight, BMI, blood pressure
- Cardiac examination: cardiac output
- Vascular measurements: Carotid intima media thickness, total peripheral resistance, blood pressure, flow-mediated vascular dilatation, critical flicker frequency, pulse wave velocity, augmentation index
- Serum analysis: basic laboratory, multiplex analysis (human vascular inflammation, human angiogenesis and adhesion molecule panel)
| Study group | Role | What they receive |
|---|---|---|
| Patient after pre-eclampsia | Patients with pre-eclampsia who were treated at the University Hospital of Jena between 1999-2009. Receives: Other: Primary data collection | |
| Patients after PETN treatment | Patients of the PETN pilot study, with PETN and patients who received PETN as an individual therapy trial Receives: Other: Primary data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular health as combined outcome
Comparison of the vascular health of patients after pre-eclampsia with that of women with complication-free pregnancies 10-20 years after pregnancy by assessing physical parameters (height, weight, Blood pressure, bioelectric impedance analysis), measuring cardiac output, transthoracic echocardiography, carotid intima media thickness, total vascular resistance, flow mediated dilation, critical flicker frequency, puls-wave velocity and augmentation index
Measured: 1 day 10-20 years after pregnancy
Potential long-term effect of PETN treatment using combined outcome of vascular health measurements in correlaation with treatment with PETN
Analysis of a possible long-term effect of PETN treatment during pregnancy based on a vascular health comparison of patients who received PETN in the PETN pilot study from 2002 to 2008, or who received it in a personalised therapy trial, with those who received placebo or no therapy
Measured: 1 day 10-20 years after pregnancy
Endothelial cell senescence using senescence characterization of young and treated HUVEC cells
In vitro analysis of endothelial cell senescence established by hosting group after pre-eclampsia induced stress effect, as well as the possible protective effect of PETN on endothelial cell aging
Measured: 1 day 10-20 years after pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Sep 2019
- Primary completion10 Dec 2021
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Multhaup, Dr. med., Principal investigator, Klinik für Geburtsmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484766
- Sponsor's protocol ID
- 2019-1498
- Acronym
- PAVA
- Status last verified
- Apr 2023
- First submitted
- 15 Apr 2020
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preeclampsia Associated Vascular Age- Long-term Follow-up and New Prevention Strategy
- ClinicalTrials.gov ID
- NCT04484766
- Acronym / sponsor ID
- PAVA / 2019-1498
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 24 Jul 2020 (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.
To evaluate cardiovascular health, especially endothelial health, of women after pre-eclampsia compared to women without pre-eclampsia, and to compare women who had taken PETN during pregnancy with women who had not attempted treatment
Detailed description
The clinical observation that women with pre-eclampsia have a high risk of early onset cardiovascular disease with increased disease-associated mortality has led to the hypothesis that the endothelial status of these women is characterized by early onset of aging. We want to investigate the relationship between endothelial aging and pregnancy disorders such as pre-eclampsia, which are dominated by endothelial dysfunction. Do endothelial changes precede pregnancy and cause pre-eclampsia and later accelerated cardiovascular aging, or does pre-eclampsia trigger premature endothelial aging in affected individuals for the first time? The aim of this study is to investigate the cardiovascular health of women 10 to 20 years after pre-eclampsia and to compare it with that of women with uneventful pregnancies. In addition, the potential long-term endothelial protective effect of the NO-donor pentaerithrityltetranitrate (PETN) is investigated.
This in vivo study will be extended in vitro by the analysis of senescence induction in endothelial cells after pre-eclampsia associated stress. Additionally, the potential protective effect of PETN on stress-induced senescence will be evaluated.
The ultimate goal is to establish a prospective long-term study on the effect of PETN on vascular health in women with pre-eclampsia to assess whether treatment of endothelial dysfunction during pregnancy could reduce endothelial aging and thus premature cardiovascular morbidity and mortality in millions of women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient after pre-eclampsia | – | Other: Primary data collectionPatients with pre-eclampsia who were treated at the University Hospital of Jena between 1999-2009. |
| Patients after PETN treatment | – | Other: Primary data collectionPatients of the PETN pilot study, with PETN and patients who received PETN as an individual therapy trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pre-eclampsia 10 to 20 years ago. The patients are matched with the next consenting patient who gave birth without pregnancy complications. Only singleton pregnancies born between the 24th and 42nd week of pregnancy are considered. Patients with and without PETN treatment are recruited from the patients who participated in the PETN pilot study from 2002 to 2008. In addition, patients are recruited who received PETN treatment as a personalised therapy trial. These are matched by patients without treatment. The matching includes the indication for treatment, the week of pregnancy at diagnosis and the percentiles of fetal growth
Key inclusion criteria (6 listed)
- Participants of the PETN pilot study from 2002-2008
- controls: uneventful pregnancies from 2002-2008
- Patients with pre-eclampsia with PETN treatment 10-20 years ago
- Controls: patients with pre-eclampsia without PETN treatment 10-20 years ago
- Written Informed Consent
Key exclusion criteria (2 listed)
- Patients who refuse to participate in the study
- Impossibility of the outpatient presentation
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 |
|---|---|---|
| Primary data collectionAlso: Physical examination, Cardiac measurement, Vascular Measurement, Serum analysisPrimary data collection takes place via questionnaires outside the study centre. All other investigations take place at the study centre: * Physical examination: height, weight, BMI, blood pressure * Cardiac examination: cardiac output * Vascular measurements: Carotid intima media thickness, total peripheral resistance, blood pressure, flow-mediated vascular dilatation, critical flicker frequency, pulse wave velocity, augmentation index * Serum analysis: basic laboratory, multiplex analysis (human vascular inflammation, human angiogenesis and adhesion molecule panel) | Other | Patient after pre-eclampsia, Patients after PETN treatment |
Primary outcome
vascular health as combined outcome
Time frame: 1 day 10-20 years after pregnancy
Comparison of the vascular health of patients after pre-eclampsia with that of women with complication-free pregnancies 10-20 years after pregnancy by assessing physical parameters (height, weight, Blood pressure, bioelectric impedance analysis), measuring cardiac output, transthoracic echocardiography, carotid intima media thickness, total vascular resistance, flow mediated dilation, critical flicker frequency, puls-wave velocity and augmentation index
Potential long-term effect of PETN treatment using combined outcome of vascular health measurements in correlaation with treatment with PETN
Time frame: 1 day 10-20 years after pregnancy
Analysis of a possible long-term effect of PETN treatment during pregnancy based on a vascular health comparison of patients who received PETN in the PETN pilot study from 2002 to 2008, or who received it in a personalised therapy trial, with those who received placebo or no therapy
Endothelial cell senescence using senescence characterization of young and treated HUVEC cells
Time frame: 1 day 10-20 years after pregnancy
In vitro analysis of endothelial cell senescence established by hosting group after pre-eclampsia induced stress effect, as well as the possible protective effect of PETN on endothelial cell aging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Anna Multhaup, Dr. med. principal investigator
Klinik für Geburtsmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Jena University Hospital at 1 site in Germany.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. 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 Germany. 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.
Are results available for this study?
Results are not available in the source record.
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?
vascular health as combined outcome (time frame: 1 day 10-20 years after pregnancy). The study lists 3 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 14 Apr 2023.