Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-04 @ 2:05 AM
Study NCT ID:
NCT03472495
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2018-02-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001282', 'term': 'Atrial Flutter'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Tammy.Nguyen@vcuhealth.org', 'phone': '8046630969', 'title': 'Tammy Nguyen, PharmD', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 hours', 'description': 'self report by participant Only bradycardia (HR \\<60 beats/min) or hypotension (SBP \\<90 mmHg requiring intervention including IVF bolus administration, vasopressors, or medication discontinuation) related adverse events were recorded.\n\nMortality was not recorded Non-serious adverse events were not recorded', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Immediate Release Diltiazem', 'description': 'Diltiazem immediate release 60mg orally once (Diltiazem oral product)\n\nDiltiazem Oral Product: Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \\<60 kg)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Continuous Infusion IV Diltiazem', 'description': 'Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \\<110 (Diltiazem Injectable Product)\n\nDiltiazem Injectable Product: Diltiazem Continuous Infusion Titrated', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Braydcardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Heart Rate Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Immediate Release Diltiazem', 'description': 'Diltiazem immediate release 60mg orally once (Diltiazem oral product)\n\nDiltiazem Oral Product: Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \\<60 kg)'}, {'id': 'OG001', 'title': 'Continuous Infusion IV Diltiazem', 'description': 'Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \\<110 (Diltiazem Injectable Product)\n\nDiltiazem Injectable Product: Diltiazem Continuous Infusion Titrated'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hrs', 'description': 'Number of participant achieving heart rate control (defined as: HR \\<110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration between oral immediate release and intravenous continuous infusion diltiazem', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Immediate Release Diltiazem', 'description': 'Diltiazem immediate release 60mg orally once (Diltiazem oral product)\n\nDiltiazem Oral Product: Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \\<60 kg)'}, {'id': 'OG001', 'title': 'Continuous Infusion IV Diltiazem', 'description': 'Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \\<110 (Diltiazem Injectable Product)\n\nDiltiazem Injectable Product: Diltiazem Continuous Infusion Titrated'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hrs', 'description': 'Number of participants with heart rate or blood pressure adverse events: Heart rate \\< 60 beats/min, or systolic blood pressure \\<90 mmHg requiring intervention (intravenous fluid bolus, vasopressors, medication discontinuation)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participant Specific Variables Associated With Heart Rate Control in Each Treatment Arm', 'timeFrame': '4 hrs', 'description': 'These variables include: Age, sex, race, weight, history of atrial fibrillation or flutter, history of hypertension, history of congestive heart failure, prior medication therapy, mean initial HR, duration of atrial fibrillation or flutter episode (\\<48 hrs or \\>48 hrs), mean initial diltiazem dose (mg/kg)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Immediate Release Diltiazem', 'description': 'Diltiazem immediate release 60mg orally once (Diltiazem oral product)\n\nDiltiazem Oral Product: Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \\<60 kg)'}, {'id': 'FG001', 'title': 'Continuous Infusion IV Diltiazem', 'description': 'Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \\<110 (Diltiazem Injectable Product)\n\nDiltiazem Injectable Product: Diltiazem Continuous Infusion Titrated'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Treatment no longer indicated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Immediate Release Diltiazem', 'description': 'Diltiazem immediate release 60mg orally once (Diltiazem oral product)\n\nDiltiazem Oral Product: Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \\<60 kg)'}, {'id': 'BG001', 'title': 'Continuous Infusion IV Diltiazem', 'description': 'Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \\<110 (Diltiazem Injectable Product)\n\nDiltiazem Injectable Product: Diltiazem Continuous Infusion Titrated'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '58.3', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-03', 'size': 352254, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-01T12:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2018-02-23', 'resultsFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-03', 'studyFirstPostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participant Specific Variables Associated With Heart Rate Control in Each Treatment Arm', 'timeFrame': '4 hrs', 'description': 'These variables include: Age, sex, race, weight, history of atrial fibrillation or flutter, history of hypertension, history of congestive heart failure, prior medication therapy, mean initial HR, duration of atrial fibrillation or flutter episode (\\<48 hrs or \\>48 hrs), mean initial diltiazem dose (mg/kg)'}], 'primaryOutcomes': [{'measure': 'Heart Rate Control', 'timeFrame': '2 hrs', 'description': 'Number of participant achieving heart rate control (defined as: HR \\<110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration between oral immediate release and intravenous continuous infusion diltiazem'}], 'secondaryOutcomes': [{'measure': 'Adverse Event Rate', 'timeFrame': '4 hrs', 'description': 'Number of participants with heart rate or blood pressure adverse events: Heart rate \\< 60 beats/min, or systolic blood pressure \\<90 mmHg requiring intervention (intravenous fluid bolus, vasopressors, medication discontinuation)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diltiazem', 'Atrial Fibrillation', 'Atrial Flutter', 'Emergency Medicine'], 'conditions': ['Atrial Fibrillation and Flutter']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the incidence of rate control (defined as: HR \\<110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration between oral immediate release diltiazem and intravenous continuous infusion diltiazem.', 'detailedDescription': 'Atrial fibrillation (AF), a supraventricular tachyarrhythmia, is the primary diagnosis for over 467,000 hospitalizations each year. Historically, there have been two approaches to managing AF in the emergency department (ED): rate control and rhythm control.\n\nThe AFFIRM trial compared rate and rhythm control in 4,060 patients. It found no difference in mortality with the rate control approach and less hospitalizations. As a result, both rhythm and rate control are options in stable patients with an AF duration of \\< 48 hours. After 48 hours, rate control is preferred because of the increased risk of ischemic stroke. The subsequent RACE II trial, established that lenient heart rate control (HR \\<110 beats/min) was as effective as strict control (HR \\<80 beats/min) in preventing cardiovascular events and required less outpatient visits to achieve the goal HR. As a result of both the AFFIRM and RACE II trials, a rate control approach with a goal HR of \\<80-110 beats/min is the management plan for a majority of patients who present to the ED in AF. According to the American Heart Association 2014 guidelines, the initial acute, emergent management of atrial fibrillation and flutter (AFF) are similar and there are a number of medications used for rate control including beta blockers and non-dihydropyridine calcium channel blockers.\n\nDiltiazem, a non-dihydropyridine calcium channel blocker, is often the medication of choice in the management of AFF due to its ability to be given as an intravenous (IV) push, continuous infusion, and oral (PO) immediate release or extended release tablet. In the ED, a loading dose of IV diltiazem 0.25 mg/kg is usually administered to obtain a heart rate of \\< 110 beats/min or a decrease of at least 20% in the ventricular rate. If this does not work then a second bolus of 0.35mg/kg is administered. Once rate control of \\<110 beats/min or a 20% decrease in ventricular rate is obtained physicians typically chose between oral immediate release diltiazem tablet or IV continuous infusion diltiazem to maintain heart rate control. Both options allow for dose changes in the short term. The oral immediate release diltiazem tablet has a fast onset of action of 30-60 minutes and is dosed every 6 hours. Intravenous continuous infusion diltiazem has a variable onset of action with a titration frequency of every 15-30 minutes. The use of oral diltiazem allows for possible placement on a monitored general floor bed, whereas an intravenous drip requires placement to step down or intensive level of care. This impacts bed status and length of stay in the emergency department. Both oral and intravenous diltiazem are used clinically; however, no prospective studies exist comparing the two strategies. Retrospective data suggests that both forms are equal in their ability to control heart rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>/= 18 years old\n* Atrial fibrillation or flutter on electrocardiogram\n* Heart rate \\>110 beats/min\n* Systolic blood pressure \\>/= 90 mmHg\n\nExclusion Criteria:\n\n* Limited English proficiency (LEP)\n* Pregnant\n* Prisoners\n* Wolff Parkinson White syndrome\n* Administration of electrical or chemical cardioversion before screening\n* Administration of other antiarrhythmics for acute heart rate control (excluding adenosine)\n* History of allergy or idiosyncratic reaction to diltiazem\n* Unable to take oral medications\n* Heart rate \\<60 beats/min'}, 'identificationModule': {'nctId': 'NCT03472495', 'acronym': 'OVID RAF', 'briefTitle': 'Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial', 'orgStudyIdInfo': {'id': 'HM20009559'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Immediate Release Diltiazem', 'description': 'Diltiazem immediate release 60mg orally once (Diltiazem oral product)', 'interventionNames': ['Drug: Diltiazem Oral Product']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Infusion IV Diltiazem', 'description': 'Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \\<110 (Diltiazem Injectable Product)', 'interventionNames': ['Drug: Diltiazem Injectable Product']}], 'interventions': [{'name': 'Diltiazem Oral Product', 'type': 'DRUG', 'description': 'Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \\<60 kg)', 'armGroupLabels': ['Oral Immediate Release Diltiazem']}, {'name': 'Diltiazem Injectable Product', 'type': 'DRUG', 'description': 'Diltiazem Continuous Infusion Titrated', 'armGroupLabels': ['Continuous Infusion IV Diltiazem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Tammy T Nguyen, PharmD, BCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}