Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-31 @ 9:09 AM
Study NCT ID:
NCT04484766
Status:
UNKNOWN
Last Update Posted:
2023-04-14
First Post:
2020-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preeclampsia Associated Vascular Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2020-04-15', 'studyFirstSubmitQcDate': '2020-07-20', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vascular health as combined outcome', 'timeFrame': '1 day 10-20 years after pregnancy', 'description': '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'}, {'measure': 'Potential long-term effect of PETN treatment using combined outcome of vascular health measurements in correlaation with treatment with PETN', 'timeFrame': '1 day 10-20 years after pregnancy', 'description': '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'}, {'measure': 'Endothelial cell senescence using senescence characterization of young and treated HUVEC cells', 'timeFrame': '1 day 10-20 years after pregnancy', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-Eclampsia']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nThis 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nPatients 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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants of the PETN pilot study from 2002-2008\n* controls: uneventful pregnancies from 2002-2008\n* Patients with pre-eclampsia with PETN treatment 10-20 years ago\n* Controls: patients with pre-eclampsia without PETN treatment 10-20 years ago\n* Written Informed Consent\n* Singleton pregnancy\n\nExclusion criteria:\n\n* Patients who refuse to participate in the study\n* Impossibility of the outpatient presentation'}, 'identificationModule': {'nctId': 'NCT04484766', 'acronym': 'PAVA', 'briefTitle': 'Preeclampsia Associated Vascular Aging', 'organization': {'class': 'OTHER', 'fullName': 'Jena University Hospital'}, 'officialTitle': 'Preeclampsia Associated Vascular Age- Long-term Follow-up and New Prevention Strategy', 'orgStudyIdInfo': {'id': '2019-1498'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient after pre-eclampsia', 'description': 'Patients with pre-eclampsia who were treated at the University Hospital of Jena between 1999-2009.', 'interventionNames': ['Other: Primary data collection']}, {'label': 'Patients after PETN treatment', 'description': 'Patients of the PETN pilot study, with PETN and patients who received PETN as an individual therapy trial', 'interventionNames': ['Other: Primary data collection']}], 'interventions': [{'name': 'Primary data collection', 'type': 'OTHER', 'otherNames': ['Physical examination', 'Cardiac measurement', 'Vascular Measurement', 'Serum analysis'], 'description': 'Primary data collection takes place via questionnaires outside the study centre.\n\nAll other investigations take place at the study centre:\n\n* Physical examination: height, weight, BMI, blood pressure\n* Cardiac examination: cardiac output\n* Vascular measurements: Carotid intima media thickness, total peripheral resistance, blood pressure, flow-mediated vascular dilatation, critical flicker frequency, pulse wave velocity, augmentation index\n* Serum analysis: basic laboratory, multiplex analysis (human vascular inflammation, human angiogenesis and adhesion molecule panel)', 'armGroupLabels': ['Patient after pre-eclampsia', 'Patients after PETN treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07747', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Anna Multhaup, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Geburtsmedizin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jena University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}