Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-03-10 @ 2:34 AM
Study NCT ID:
NCT01655303
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2012-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rate Control in Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}, {'id': 'D008790', 'term': 'Metoprolol'}, {'id': 'D014700', 'term': 'Verapamil'}, {'id': 'D004110', 'term': 'Diltiazem'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-30', 'studyFirstSubmitDate': '2012-07-30', 'studyFirstSubmitQcDate': '2012-07-30', 'lastUpdatePostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate less than 100 per minute', 'timeFrame': 'In 1 hour', 'description': 'Ventricular rate less than 100 per minute after 1 hour of per oral medication administration'}], 'secondaryOutcomes': [{'measure': 'Drugs adverse effects', 'timeFrame': '2 hours', 'description': 'Drugs adverse effects seen in patients in 2 hours after per oral medication administration'}, {'measure': 'Unstability in hemodynamic', 'timeFrame': '2 hours', 'description': 'Hemodynamic instability (systolic blood pressure less than 90 mmHg, loss of consciousness, pulmonary edema, chest pain)'}]}, 'conditionsModule': {'conditions': ['Rapid Ventricular Response Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Rate control in atrial fibrillation is a usual battle in emergency departments. Oral medications have a natural superiority to intravenous ones because they are easy-to-use and decrease the workload in busy emergency departments.\n\nThis study wants to find an effective oral medication for rate control in rapid ventricular response atrial fibrillation. Propranolol and Metoprolol, Diltiazem and Verapamil are compared in patients with a stable hemodynamic status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 18 years old\n* Stability in hemodynamic\n\nExclusion Criteria:\n\n* Systolic blood pressure less than 90 mm Hg\n* Altered mental status attributable to rapid ventricular response atrial fibrillation\n* Acute pulmonary edema attributable to rapid ventricular response atrial fibrillation\n* Chest pain attributable to rapid ventricular response atrial fibrillation\n* Allergy to Propranolol or Metoprolol or Verapamil or Diltiazem\n* History of asthma'}, 'identificationModule': {'nctId': 'NCT01655303', 'briefTitle': 'Rate Control in Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Oral Propranolol, Diltiazem, Metoprolol and Verapamil in Atrial Fibrillation Rate Control in Patients With Stable Hemodynamic Status', 'orgStudyIdInfo': {'id': '16057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metoprolol Per Oral', 'description': '50 mg Metoprolol', 'interventionNames': ['Drug: Metoprolol']}, {'type': 'EXPERIMENTAL', 'label': 'Verapamil', 'description': '40 mg Verapamil Per Oral', 'interventionNames': ['Drug: Verapamil']}, {'type': 'EXPERIMENTAL', 'label': 'Propranolol', 'description': '40 mg Propranolol Per Oral', 'interventionNames': ['Drug: Propranolol']}, {'type': 'EXPERIMENTAL', 'label': 'Diltiazem', 'description': '60 mg Diltiazem Per Oral', 'interventionNames': ['Drug: Diltiazem']}], 'interventions': [{'name': 'Propranolol', 'type': 'DRUG', 'otherNames': ['Inderal'], 'armGroupLabels': ['Propranolol']}, {'name': 'Metoprolol', 'type': 'DRUG', 'otherNames': ['Metoral'], 'armGroupLabels': ['Metoprolol Per Oral']}, {'name': 'Verapamil', 'type': 'DRUG', 'armGroupLabels': ['Verapamil']}, {'name': 'Diltiazem', 'type': 'DRUG', 'armGroupLabels': ['Diltiazem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14436151', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Rasoul-e-Akram Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}