Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT06069102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-03
First Post:
2023-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal Blood Pressure Treatment Thresholds Postpartum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D004461', 'term': 'Eclampsia'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Once randomization is complete, there will be no blinding of participants, care providers or investigators. Outcomes assessors will be masked to intervention arm.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The investigators will conduct a prospective single site, single-blinded, parallel randomized control trial in which individuals diagnosed with HDP will be randomized to usual care or tight blood pressure control for therapeutic intent. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2023-09-28', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of participants eligible, enrolled and retained (feasibility)', 'timeFrame': 'Baseline to approximately 6 months postpartum', 'description': 'To determine if a randomized controlled trial of tight blood pressure control (\\<135/85 mmHg on home blood pressure monitoring) vs. standard of care (\\<150/100 mmHg on home blood pressure monitoring) in postpartum individuals following a hypertensive disorder of pregnancy (HDP) is feasible.'}], 'secondaryOutcomes': [{'measure': 'Anti-hypertensive medication use (efficacy)', 'timeFrame': '6 months postpartum', 'description': 'Anti-hypertensive medication use'}, {'measure': 'Anti-hypertensive medication use', 'timeFrame': '6 weeks postpartum', 'description': 'Anti-hypertensive medication use'}, {'measure': 'Mean arterial pressure (efficacy)', 'timeFrame': '6 months postpartum', 'description': 'Mean arterial pressure (systolic BP + 2\\*diastolic BP / 3)'}, {'measure': 'Mean arterial pressure', 'timeFrame': '6 weeks postpartum', 'description': 'Mean arterial pressure (systolic BP + 2\\*diastolic BP / 3)'}, {'measure': 'Systolic blood pressure', 'timeFrame': '6 months postpartum', 'description': 'Mean systolic blood pressure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '6 months postpartum', 'description': 'Mean diastolic blood pressure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '6 weeks postpartum', 'description': 'Mean diastolic blood pressure'}, {'measure': 'Change in MAP', 'timeFrame': 'Enrollment to 6 weeks postpartum', 'description': 'Change in mean arterial pressure (systolic BP + 2\\*diastolic BP / 3)'}, {'measure': 'Change in systolic BP', 'timeFrame': 'Enrollment to 6 weeks postpartum', 'description': 'Change in systolic BP'}, {'measure': 'Change in diastolic BP', 'timeFrame': 'Enrollment to 6 weeks postpartum', 'description': 'Change in diastolic BP'}, {'measure': 'Proportion of participants with readmissions', 'timeFrame': 'Enrollment through six months postpartum', 'description': 'Postpartum hospital readmissions'}, {'measure': 'Proportion of participants with ER visits', 'timeFrame': 'Enrollment through six months postpartum', 'description': 'Emergency room visits'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension'], 'conditions': ['Hypertensive Disorder of Pregnancy', 'Pre-Eclampsia', 'Hypertension', 'Eclampsia', 'Gestational Hypertension', 'Cardiovascular Diseases', 'Toxemia', 'Pregnancy Complications', 'Vascular Diseases', 'Hypertension, Pregnancy Induced', 'Hypertension;Pre-Eclamptic']}, 'descriptionModule': {'briefSummary': "The objective of this research project is to conduct a single-site pilot trial within our institution's clinical remote blood pressures (BP) management program to assess the feasibility and effect of tight blood pressure control versus usual care in the immediate postpartum period after a hypertensive disorder of pregnancy (HDP).\n\nThe investigators' central hypothesis is that tight blood pressure control will be feasible and acceptable to postpartum individuals and will result in lower BP at six months postpartum and a reduction in postpartum hospital readmissions. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.", 'detailedDescription': 'The investigators will determine the feasibility of conducting a randomized controlled trial of tight blood pressure control (\\<135/85 mmHg on home BP monitoring) vs. standard of care (\\<150/100 mmHg on home BP monitoring) in postpartum individuals following a HDP with assessment of individuals who are eligible, enrolled, and remain in the study until six weeks postpartum. Individuals who are retained in the study for 6 months postpartum. Lastly, investigators will analyze effect outcomes to inform the sample size for a subsequent large-scale randomized trial. This will be done through analysis of mean arterial pressure (MAP), systolic blood pressure, and diastolic blood pressure of participants at 6 weeks and at 6 months postpartum. The study will be conducted on the postpartum unit of Magee-Womens Hospital. Participants will be enrolled at the time of postpartum hospitalization with study visit #1 occurring in the hospital. At this study visit, participants will be administered questionnaires, will provide a blood sample, and BP will be measured. Study visit #2 will be a remote study visit conducted via telemedicine or a telephone call at 6 weeks postpartum. At this visit, participants will provide questionnaires and blood pressure data. Study visit #3 will be a remote study visit conducted via telemedicine or a telephone call at 6 months postpartum. At this visit, participants will again provide questionnaires and blood pressure data.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postpartum individuals ≥18 years old\n* Preeclampsia or gestational hypertension diagnosis (complying ACOG criteria)\n* Enrolled in remote BP management program.\n\nExclusion Criteria:\n\n* Pre-pregnancy hypertension\n* Pre-pregnancy diabetes\n* Maternal cardiac disease\n* Chronic kidney disease'}, 'identificationModule': {'nctId': 'NCT06069102', 'briefTitle': 'Optimal Blood Pressure Treatment Thresholds Postpartum', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'OPT-BP: Optimal Blood Pressure Treatment Thresholds Following a Hypertensive Disorder of Pregnancy: A Pilot Trial', 'orgStudyIdInfo': {'id': 'STUDY23060147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Group', 'description': "Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.", 'interventionNames': ['Drug: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention (Tight Blood Pressure Control) Group', 'description': "BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg.", 'interventionNames': ['Drug: Tight blood pressure control']}], 'interventions': [{'name': 'Usual care', 'type': 'DRUG', 'description': "The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.", 'armGroupLabels': ['Usual Care Group']}, {'name': 'Tight blood pressure control', 'type': 'DRUG', 'otherNames': ['Tight control'], 'description': "The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.", 'armGroupLabels': ['Intervention (Tight Blood Pressure Control) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Magee-Womens Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Alisse K Hauspurg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UPMC Magee Women's Hospital"}]}, 'ipdSharingStatementModule': {'url': 'https://biolincc.nhlbi.nih.gov/home/', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Within a year after outcomes are published and no later than 3 years after the end of clinical activities.', 'ipdSharing': 'YES', 'description': 'Deidentified data (including data dictionaries) will be shared at the direction of the primary investigator. Data will include blood pressure, weight, demographics, physical activity, and pregnancy related information. Additional documents (such as the study protocol) will be made available. The dataset for our project will be prepared according to requirements for and stored on the Clinicaltrials.gov data repository. Per the NIH guidelines, the dataset will be submitted to the program officer within a year after the outcomes are published and no later than 3 years after the end of clinical activities.', 'accessCriteria': 'NHLBI data repository request process'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alisse Hauspurg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alisse Hauspurg', 'investigatorAffiliation': 'University of Pittsburgh'}}}}