Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT07204756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HOPE-BP 2.0: Evaluating the Optimal Duration of Postpartum Remote Blood Pressure Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014115', 'term': 'Toxemia'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-09-24', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Week 6', 'description': "The primary outcome will be the patient's diastolic blood pressure (DBP) at their 6-week postpartum visit."}], 'secondaryOutcomes': [{'measure': 'Systolic Blood Pressure at 6 weeks post-partum', 'timeFrame': 'Week 6', 'description': "Patient's systolic blood pressure at their 6-week postpartum visit"}, {'measure': '6-Week Post-partum Follow-up Rates', 'timeFrame': 'Week 6', 'description': 'Participants who complete a 6-week post-partum visit / Total participants eligible for a 6-week post-partum visit'}, {'measure': 'Unscheduled OB visit, triage visit, ED visit, or readmission rates', 'timeFrame': 'Week 6'}, {'measure': 'Patient Satisfaction Survey responses at 6 weeks', 'timeFrame': 'Week 6', 'description': 'PSS Score, where higher score indicates greater satisfaction'}, {'measure': 'Rate of severe hypertension', 'timeFrame': 'Week 6', 'description': 'defined as systolic blood pressure ≥ 160mmHg and/or DBP ≥ 110 mmHg'}, {'measure': 'Rate of new hypertension diagnosis at 6 weeks postpartum', 'timeFrame': 'Week 6', 'description': 'based on American Heart Association and American College of Cardiology criteria (AHA/ACC)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum', 'Hypertension', 'Hypertensive Disorder of Pregnancy']}, 'descriptionModule': {'briefSummary': "Postpartum remote blood pressure monitoring programs for patients with hypertensive disorders of pregnancy (HDP) are becoming part of standard postpartum management. Existing programs range in duration from 2 to 6 weeks but there has not been any evaluation as to what program duration is optimal. The primary objective of this study is to evaluate the impact of program duration on clinical outcomes for patients participating in a single institution's postpartum remote blood pressure monitoring program for patients with HDP."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Discharged after delivery at University of Minnesota Medical Center\n* Enrolled into the HOPE-BP Program\n\nExclusion Criteria:\n\n* Ongoing antihypertensive medication use at 2 weeks (time of randomization)\n* Have a medical comorbidity that would not be clinically appropriate to randomize\n* Patients opted out of clinical research'}, 'identificationModule': {'nctId': 'NCT07204756', 'briefTitle': 'HOPE-BP 2.0: Evaluating the Optimal Duration of Postpartum Remote Blood Pressure Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'HOPE-BP 2.0: Evaluating the Optimal Duration of Postpartum Remote Blood Pressure Monitoring', 'orgStudyIdInfo': {'id': 'OBGYN-2025-34107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2-Week Arm', 'description': 'Participants randomized into the 2 week arm will be immediately unenrolled from the postpartum remote blood pressure monitoring program and resume standard postpartum care', 'interventionNames': ['Diagnostic Test: 2-Week Home Monitoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6-Week Arm', 'description': 'Patients randomized into the 6 week arm will continue and complete the program in its entirety per current SOC (4 additional weeks)', 'interventionNames': ['Diagnostic Test: 6-Week Home Monitoring']}], 'interventions': [{'name': '2-Week Home Monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'Those who are randomized into the 2-week intervention arm will be unenrolled from the postpartum remote blood pressure monitoring program and therefore will no longer be transmitting twice daily blood pressures for review.', 'armGroupLabels': ['2-Week Arm']}, {'name': '6-Week Home Monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': "HOPE-BP provides remote monitoring for the 35% of approximately 2,800 annual births at our institution complicated by HDP. Eligible patients enroll at hospital discharge into a 6-week program, submitting blood pressure readings twice daily via Epic's MyChart Care Companion. Participants receive immediate automated feedback, and a dedicated Maternal Fetal Medicine nursing team reviews data daily (Monday-Friday, 8 AM-4 PM), initiating or adjusting antihypertensive therapy as needed.", 'armGroupLabels': ['6-Week Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Erin Linden', 'role': 'CONTACT', 'email': 'linde491@umn.edu', 'phone': '612-625-2273'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Erin Linden', 'role': 'CONTACT', 'email': 'linde491@umn.edu', 'phone': '612-625-2273'}], 'overallOfficials': [{'name': 'Bethany Sabol, MD MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}