{ "FullStudy":{ "Rank":217599, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519297", "OrgStudyIdInfo":{ "OrgStudyId":"PP PE 2012" }, "Organization":{ "OrgFullName":"Brigham and Women's Hospital", "OrgClass":"OTHER" }, "BriefTitle":"Preeclampsia: A Marker for Future Cardiovascular Risk in Women", "OfficialTitle":"Preeclampsia: A Marker for Future Cardiovascular Risk in Women" }, "StatusModule":{ "StatusVerifiedDate":"January 2019", "OverallStatus":"Suspended", "WhyStopped":"Pending funding", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 2017", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"July 2019", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 15, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 17, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Ellen W. Seely", "ResponsiblePartyInvestigatorTitle":"M.D.", "ResponsiblePartyInvestigatorAffiliation":"Brigham and Women's Hospital" }, "LeadSponsor":{ "LeadSponsorName":"Brigham and Women's Hospital", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This study will compare blood vessel and hormone differences between women who have a history of a pregnancy complicated by preeclampsia or high blood pressure, and women who have a history of uncomplicated pregnancy in the last 10 years. The investigators hypothesize that postpartum women with history of preeclampsia will have altered blood vessel function and abnormal hormone levels compared with postpartum women with history of uncomplicated pregnancy.\n\nThis study will take place over the course of 2 weeks. Each subject will be assessed on a fixed low-salt diet and a fixed high-salt diet. Subjects will have 2 non-invasive blood vessel imaging tests and fasting blood draws." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Preeclampsia", "Pregnancy Induced Hypertension" ] }, "KeywordList":{ "Keyword":[ "Preeclampsia", "Pregnancy Induced Hypertension" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Screening", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"150", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Single arm intervention", "ArmGroupType":"Other", "ArmGroupDescription":"Irbesartan 150 mg orally for one dose", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Irbesartan" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Irbesartan", "InterventionDescription":"150mg orally for one dose", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Single arm intervention" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Vascular function", "PrimaryOutcomeDescription":"Assess vascular function after administration of an angiotensin receptor blocker.", "PrimaryOutcomeTimeFrame":"60 minutes" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Hormonal measurements", "SecondaryOutcomeDescription":"Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.", "SecondaryOutcomeTimeFrame":"60 minutes" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy female premenopausal volunteers, with regular menstrual cycles (at least 8 cycles per year)\nAge 21 to 50 years\nSystolic blood pressure <140 and >90 mmHg and diastolic blood pressure <90 and >60 mmHg at the screening visit\nBody mass index < 35 kg/m2\nHistory of normotensive pregnancy or history of preeclamptic or hypertensive pregnancy within the last 10 years\nNo clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis, and electrocardiogram)\n\nExclusion Criteria:\n\nCurrent pregnancy\nLactation\nElevated blood pressure (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg)\nCurrent diagnosis of hypertension\nCurrent diagnosis of diabetes mellitus\nPersonal history of coronary disease, stroke and kidney disease\nUse of prescription medications (with the exception of stable thyroid hormone replacement dose) within 2 weeks of study\nUse of oral contraceptives or other hormone therapy within 3 months of study;\nRenal impairment (estimated GFR<60)\nActive liver disease (AST, ALT, alkaline phosphatase > 1.5 times normal);\nCurrent smoking, defined as smoking within the 6 months before the screening visit\nCurrent or past recreational drug use", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"Female", "MinimumAge":"21 Years", "MaximumAge":"50 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Ellen W Seely, MD", "OverallOfficialAffiliation":"Brigham and Women's Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Brigham and Women's Hospital", "LocationCity":"Boston", "LocationState":"Massachusetts", "LocationZip":"02115", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000077405", "InterventionMeshTerm":"Irbesartan" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000959", "InterventionAncestorTerm":"Antihypertensive Agents" },{ "InterventionAncestorId":"D000047228", "InterventionAncestorTerm":"Angiotensin II Type 1 Receptor Blockers" },{ "InterventionAncestorId":"D000057911", "InterventionAncestorTerm":"Angiotensin Receptor Antagonists" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M1786", "InterventionBrowseLeafName":"Irbesartan", "InterventionBrowseLeafAsFound":"Irbesartan", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2858", "InterventionBrowseLeafName":"Antihypertensive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2713", "InterventionBrowseLeafName":"Angiotensin II", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M269574", "InterventionBrowseLeafName":"Giapreza", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2716", "InterventionBrowseLeafName":"Angiotensinogen", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24376", "InterventionBrowseLeafName":"Angiotensin II Type 1 Receptor Blockers", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M27503", "InterventionBrowseLeafName":"Angiotensin Receptor Antagonists", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"AnAg", "InterventionBrowseBranchName":"Antihypertensive Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"VaCoAg", "InterventionBrowseBranchName":"Vasoconstrictor Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000011225", "ConditionMeshTerm":"Pre-Eclampsia" },{ "ConditionMeshId":"D000046110", "ConditionMeshTerm":"Hypertension, Pregnancy-Induced" },{ "ConditionMeshId":"D000006973", "ConditionMeshTerm":"Hypertension" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000011248", "ConditionAncestorTerm":"Pregnancy Complications" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M12689", "ConditionBrowseLeafName":"Pre-Eclampsia", "ConditionBrowseLeafAsFound":"Preeclampsia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8607", "ConditionBrowseLeafName":"Hypertension", "ConditionBrowseLeafAsFound":"Hypertension", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M24222", "ConditionBrowseLeafName":"Hypertension, Pregnancy-Induced", "ConditionBrowseLeafAsFound":"Pregnancy Induced Hypertension", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M6216", "ConditionBrowseLeafName":"Eclampsia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12710", "ConditionBrowseLeafName":"Pregnancy Complications", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T2030", "ConditionBrowseLeafName":"Eclampsia", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }