Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-30 @ 12:33 AM
Study NCT ID:
NCT03830957
Status:
UNKNOWN
Last Update Posted:
2019-04-12
First Post:
2018-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D054143', 'term': 'Heart Failure, Systolic'}, {'id': 'D054144', 'term': 'Heart Failure, Diastolic'}, {'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077550', 'term': 'Ivabradine'}, {'id': 'D008790', 'term': 'Metoprolol'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2018-11-26', 'studyFirstSubmitQcDate': '2019-02-02', 'lastUpdatePostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '30 minutes before and after coronary CT angiography', 'description': 'Changing heart rate during imaging study'}], 'secondaryOutcomes': [{'measure': 'Dyspnea', 'timeFrame': '30 minutes before and after coronary CT angiography and 6 months later', 'description': 'Shortness of breath, or "dyspnea", is the most famous symptom of left ventricular failure. It typically appears during strenuous activities, and progresses to ordinary activities, less than ordinary activities and ultimately resting state. The severity is categorized as above (FC 1 to 4)'}, {'measure': 'Functional calss', 'timeFrame': '30 minutes before and after coronary CT angiography and 6 months later', 'description': 'Heart Failure severity has been classified according to New York Heart Association (NYHA) to:\n\n* Class I: No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF.\n* Class II: Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF.\n* Class III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF.\n* Class IV: Unable to perform any physical activity without symptoms of HF, or symptoms of HF at rest.'}, {'measure': 'Blood pressure, systolic and diastolic', 'timeFrame': '30 minutes before and after coronary CT angiography and 6 months later', 'description': 'The amount of blood pressure measured by sphygmomanometer'}, {'measure': 'Sleep quality', 'timeFrame': 'Before CT angiography and 6 months later', 'description': 'The rate of disturbed sleep measured as better than before, Worse than before, and No change\n\nThere are no standard classification for severity of this symptom. In our study, we measure this symptom as :\n\n* Better than before (1)\n* Worse than before (2)\n* No change (0)'}, {'measure': 'Appetite', 'timeFrame': 'Before CT angiography and 6 months later', 'description': 'The rate of changing in appetite level measured as better than before, Worse than before, and No change\n\nLoss of appetite is a common symptom of heart failure. There are no standard classification for severity of this symptom. In our study, we measure this symptom as :\n\n* Better than before (1)\n* Worse than before (2)\n* No change (0)'}, {'measure': 'Prolonged bradycardia', 'timeFrame': '30 minutes before and after coronary CT angiography', 'description': 'Persistence of Bradycardia more than 6 hours is called prolonged bradycardia.'}, {'measure': 'Hypotension', 'timeFrame': '30 minutes before and after coronary CT angiography', 'description': 'Systolic less than 80 mm Hg'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'CT Angiography', 'Ischemic Cardiomyopathy', 'Non-ischemic Cardiomyopathy', 'Heart Failure, Systolic', 'Heart Failure，Congestive', 'Heart Failure, Diastolic', 'Heart Rate Low']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effects of Ivabradine and metoprolol to reduce heart rate prior to coronary CT angiography in patients with advanced heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sinus rhythm\n* Heart rate \\>60/min\n\nExclusion Criteria:\n\n* Atrial fibrillation\n* Any contraindication for beta-blocker use'}, 'identificationModule': {'nctId': 'NCT03830957', 'briefTitle': 'Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker', 'organization': {'class': 'OTHER', 'fullName': 'Rajaie Cardiovascular Medical and Research Center'}, 'officialTitle': 'Randomized Clinical Trial of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker', 'orgStudyIdInfo': {'id': 'HFRC_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ivabradine', 'interventionNames': ['Drug: Ivabradine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'metoprolol', 'interventionNames': ['Drug: Metoprolol']}], 'interventions': [{'name': 'Ivabradine', 'type': 'DRUG', 'description': '7.5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 7.5 mg', 'armGroupLabels': ['Ivabradine']}, {'name': 'Metoprolol', 'type': 'DRUG', 'description': '5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 5 mg', 'armGroupLabels': ['metoprolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1996911151', 'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Ahmad Amin, MD', 'role': 'CONTACT', 'email': 'amina33@gmail.com', 'phone': '+98 21 2392', 'phoneExt': '2172'}], 'facility': 'Ahmad Amin', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rajaie Cardiovascular Medical and Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}