Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-04 @ 12:31 PM
Study NCT ID:
NCT00313157
Status:
COMPLETED
Last Update Posted:
2014-05-13
First Post:
2006-04-10
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'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008790', 'term': 'Metoprolol'}, {'id': 'D004110', 'term': 'Diltiazem'}, {'id': 'D014700', 'term': 'Verapamil'}, {'id': 'D000077261', 'term': 'Carvedilol'}], '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': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-11', 'studyFirstSubmitDate': '2006-04-10', 'studyFirstSubmitQcDate': '2006-04-10', 'lastUpdatePostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventricular rate', 'timeFrame': 'Three weeks', 'description': 'Ventricular rate evaluated after three weeks on study drug treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '27142292', 'type': 'DERIVED', 'citation': 'Horjen AW, Ulimoen SR, Enger S, Norseth J, Seljeflot I, Arnesen H, Tveit A. Troponin I levels in permanent atrial fibrillation-impact of rate control and exercise testing. BMC Cardiovasc Disord. 2016 May 4;16:79. doi: 10.1186/s12872-016-0255-x.'}, {'pmid': '25362163', 'type': 'DERIVED', 'citation': 'Corino VD, Sandberg F, Platonov PG, Mainardi LT, Ulimoen SR, Enger S, Tveit A, Sornmo L. Non-invasive evaluation of the effect of metoprolol on the atrioventricular node during permanent atrial fibrillation. Europace. 2014 Nov;16 Suppl 4:iv129-iv134. doi: 10.1093/europace/euu246.'}, {'pmid': '24700386', 'type': 'DERIVED', 'citation': 'Ulimoen SR, Enger S, Norseth J, Pripp AH, Abdelnoor M, Arnesen H, Gjesdal K, Tveit A. Improved rate control reduces cardiac troponin T levels in permanent atrial fibrillation. Clin Cardiol. 2014 Jul;37(7):422-7. doi: 10.1002/clc.22281. Epub 2014 Apr 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of metoprolol, verapamil, diltiazem and carvedilol on ventricular rate, working capacity and quality of life in patients with chronic atrial fibrillation.', 'detailedDescription': 'This is a randomised, single blinded, cross-over study comparing the efficacy of metoprolol 100 mg o.d., verapamil 240 mg o.d., diltiazem 360 mg o.d. and carvedilol 25 mg o.d. in reducing ventricular rate in atrial fibrillation. A total of 60 patients will be included, with a minimum of 20 women.Patients will receive each of the drug regimens in a random sequence. Each regimen will be administered for 3 weeks, ensuring that steady-state drug concentration will be attained and to provide an adequate washout of the previous treatment. Following each regimen, exercise ECG and Holter registration will be performed and patients will undergo laboratory evaluation and complete QoL-forms. They will then be started on the next randomly assigned treatment regimen, until the entire sequence of treatment schedules is completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent or permanent atrial fibrillation with ventricular rate \\> 80/min at rest and/or \\> 100/min average at daytime.\n* Male or female, age \\> 18.\n\nExclusion Criteria:\n\n* Hypersensitivity or contraindication to metoprolol, verapamil, diltiazem or carvedilol.\n* Coronary heart disease or heart failure\n* Systolic blood pressure \\< 100 mmHg\n* AV-conduction disturbance\n* Severe hepatic or renal dysfunction\n* Thyrotoxicosis\n* Ongoing treatment with Digitalis\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT00313157', 'acronym': 'RATAF', 'briefTitle': 'RATe Control in Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Asker & Baerum Hospital'}, 'officialTitle': 'Rate Control in Atrial Fibrillation', 'orgStudyIdInfo': {'id': '2005-004221-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metoprolol', 'description': 'Treatment with Metoprolol 100 mg x 1 for three weeks', 'interventionNames': ['Drug: Metoprolol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diltiazem', 'description': 'Treatment with Diltiazem 360 mg x 1 for three weeks', 'interventionNames': ['Drug: Diltiazem']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Verapamil', 'description': 'Treatment with Verapamil 240 mg x 1 for three weeks', 'interventionNames': ['Drug: Verapamil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carvedilol', 'description': 'Treatment with Carvedilol 25 mg x 1 for three weeks', 'interventionNames': ['Drug: Carvedilol']}], 'interventions': [{'name': 'Metoprolol', 'type': 'DRUG', 'otherNames': ['Selo-Zok'], 'armGroupLabels': ['Metoprolol']}, {'name': 'Diltiazem', 'type': 'DRUG', 'otherNames': ['Cardizem'], 'armGroupLabels': ['Diltiazem']}, {'name': 'Verapamil', 'type': 'DRUG', 'otherNames': ['Isoptin Retard'], 'armGroupLabels': ['Verapamil']}, {'name': 'Carvedilol', 'type': 'DRUG', 'otherNames': ['Kredex'], 'armGroupLabels': ['Carvedilol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1309', 'city': 'Rud', 'state': 'Akershus', 'country': 'Norway', 'facility': 'Vestre Viken Hospital Trust, Baerum Hospital', 'geoPoint': {'lat': 60.38333, 'lon': 11.03333}}], 'overallOfficials': [{'name': 'Sara Reinvik Fagertun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asker and Baerum Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asker & Baerum Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sara Reinvik Ulimoe', 'investigatorAffiliation': 'Asker & Baerum Hospital'}}}}