Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-06-04 @ 5:45 PM
Study NCT ID:
NCT03877692
Status:
TERMINATED
Last Update Posted:
2020-07-22
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Control of Chronic Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The principle investigator and outcomes assessor are masked to group assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to blood pressure control', 'timeFrame': 'This outcome will be measured during antepartum admission and will start with the first dose of IV labetalol given for severe blood pressure until subsequent blood pressure check is non-severe (<160 systolic and <110 diastolic), ending with delivery', 'description': 'length of time in minutes between IV labetalol treatment and non-severe blood pressure'}, {'measure': 'Length of blood pressure control', 'timeFrame': 'This outcome will be measured during antepartum admission and will start with the first non-severe blood pressure after IV labetalol dosing until the next dose of IV labetalol is indicated (by severe blood pressure), ending with delivery', 'description': 'length of time in minutes between successful treatment resulting in non-severe blood pressure and need for next dose of IV labetalol'}], 'secondaryOutcomes': [{'measure': 'Maternal adverse events', 'timeFrame': 'within 3 months of delivery', 'description': 'Anticipated and unanticipated adverse events experienced by the mother including Symptomatic hypotension, bradsycardia, bronchospam, seizure, stroke, death'}, {'measure': 'Neonatal adverse events', 'timeFrame': 'within 28 days of delivery', 'description': 'Any complications experienced by the neonate including APGAR score \\< 5, need for respiratory support, blood glucose, death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Labetalol'], 'conditions': ['Preeclampsia With Severe Features', 'Chronic Hypertension in Obstetric Context']}, 'referencesModule': {'references': [{'pmid': '25611642', 'type': 'BACKGROUND', 'citation': 'Committee Opinion No. 623: Emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2015 Feb;125(2):521-525. doi: 10.1097/01.AOG.0000460762.59152.d7.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to understand if administration of a personalized dose of the anti-hypertensive medication, labetalol, based on patient's history of preexisting hypertension, will be more effective at controlling severe hypertension during pregnancy, compared to the current standard dosing.", 'detailedDescription': "The investigators seek to asses the effect of preexisting hypertension on the patient's response to treatment for severe hypertension in preeclampsia with severe features. The investigators hypothesize that successive administration of 40-60-80 mg of labetolol will reduce time to blood pressure control versus the standard dosing, 20-40-80 mg labetolol, recommended by the American College of Obstetricians and Gynecologists in 2015."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Gestational age ≥ 24 weeks\n* Singleton gestation\n* Chronic hypertension as defined as two elevated blood pressures (SBP ≥ 140mmHg and/or DBP ≥ 90mmHg) at least 4 hours apart before 20 weeks gestation\n\nExclusion Criteria:\n\n* Known allergic reaction to labetalol\n* Persistent mild-moderate asthma (≥ 2 rescue inhaler uses per week in the previous month)\n* Obstructive airway disease\n* Bradycardia \\< 70 beats/min\n* Heart block \\> 1st degree or history of heart failure'}, 'identificationModule': {'nctId': 'NCT03877692', 'acronym': 'ACCTIVE', 'briefTitle': 'Acute Control of Chronic Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Albany Medical College'}, 'officialTitle': 'Acute Control of Chronic Hypertension in Preeclampsia', 'orgStudyIdInfo': {'id': '5253'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental labetalol dose', 'description': 'Subjects receive 40mg, 60mg, 80mg after each severe BP', 'interventionNames': ['Drug: Experimental dosing of labetalol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Current standard of care', 'description': 'Subjects receive 20mg, 40mg, 60mg after each severe BP', 'interventionNames': ['Other: Standard dosing of labetalol']}], 'interventions': [{'name': 'Experimental dosing of labetalol', 'type': 'DRUG', 'description': 'Subjects with preexisting hypertension who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive the experimental dosing of labetolol. Subjects in both groups are managed following the standard guidelines established by ACOG (Committee Opinion #623). For each successive episode of hypertension treatment, patients are asked a set of questions to monitor for adverse medication side-effects. The fetus is electronically monitored for four hours after the last IV dose.', 'armGroupLabels': ['Experimental labetalol dose']}, {'name': 'Standard dosing of labetalol', 'type': 'OTHER', 'description': 'Subjects with preexisting hypertension who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive either the standard of care dosing of labetolol. Subjects in both groups are managed following the standard guidelines established by ACOG (Committee Opinion #623). For each successive episode of hypertension treatment, patients are asked a set of questions to monitor for adverse medication side-effects. The fetus is electronically monitored for four hours after the last IV dose.', 'armGroupLabels': ['Current standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center Obstetrics and Gynecology', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albany Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}