Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT02166060
Status:
UNKNOWN
Last Update Posted:
2014-06-18
First Post:
2014-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077550', 'term': 'Ivabradine'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-13', 'studyFirstSubmitDate': '2014-06-10', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': 'Percentage of biventricular pacing >95%', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of biventricular pacing >98%', 'timeFrame': '6 months'}, {'measure': 'Time to first inappropriate shock', 'timeFrame': '6 months'}, {'measure': 'change of mean heart rate compared with baseline', 'timeFrame': '6 months'}, {'measure': 'Cardiovascular hospitalization', 'timeFrame': '6 months'}, {'measure': 'The change between baseline and final echocardiographic parameters', 'timeFrame': '6 months'}, {'measure': 'The assessment of quality of life (SF36)', 'timeFrame': '6 months'}, {'measure': 'The change between baseline and final NYHA class', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the role of ivabradine in cardiac resynchronization recipients with an unsatisfactory percentage biventricular pacing.\n\nThe study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV treated with optimal medical therapy as clinically indicated who received CRT-D device more than 3 months ago. Patients with biventricular pacing \\<95% will and heart rate \\<70 at rest and \\>50% of heart rate in device memory \\>70 will receive ivabradine. The minimal follow-up of patients in the study will be at least six months.', 'detailedDescription': 'Approximately 30% of CRT recipients do not respond to therapy. One of the causes ot that is unsatisfactory percentage of biventricular pacing. Patients may loose biventricular pacing because of inadequate sinus tachycardia.\n\nIvabradine may prevent inadequate sinus tachycardia and improve quality of live of CRT recipients.\n\nAccording to current guidelines ivabradine is recommended in patients with symptomatic heart failure with heart rate at rest \\>70.\n\nThe hypothesis of this study is that ivabradine may increase percentage of biventricular pacing in CRT recipients who have unsatisfactory percentage of biventricular pacing and \\>50% of heart rate in device memory \\>70.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* heart failure NYHA II-IV\n* left ventricular ejection fraction =\\<35%\n* CRT-D implanted over 3 months ago\n* optimal CRT-D parameters\n* biventricular pacing \\<95% despite the optimal parameters of the device\n* optimal pharmacotherapy with the highest well-tolerated beta-adrenolytic dosage\n* heart rate at rest below 70 bpm\n* over 50% of heart rhythm over 70 bpm at interrogation with the device\n\nExclusion Criteria:\n\n* persistent atrial fibrillation/flutter\n* device associated ineffective resynchronization\n* contraindications to ivabradine'}, 'identificationModule': {'nctId': 'NCT02166060', 'acronym': 'IvaCRT', 'briefTitle': 'Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy', 'orgStudyIdInfo': {'id': 'IvaCRT KB/111/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ivabradine', 'description': 'Ivabradine 5 mg twice a day or 7,5 mg twice a day', 'interventionNames': ['Drug: Ivabradine']}], 'interventions': [{'name': 'Ivabradine', 'type': 'DRUG', 'otherNames': ['Procoralan'], 'description': 'Ivabradine 5 mg twice a day or 7,5 mg twice a day', 'armGroupLabels': ['Ivabradine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-097', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'contacts': [{'name': 'Marcin Grabowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '1st Department of Cariology of Medcial University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Marcin Grabowski, PhD', 'role': 'CONTACT', 'email': 'marcin.grabowski@wum.edu.pl', 'phone': '+48 660 751 816'}, {'name': 'Lukasz Januszkiewicz, MD', 'role': 'CONTACT', 'email': 'lukasz.jan.januszkiewicz@gmail.com', 'phone': '+48 694 333 056'}], 'overallOfficials': [{'name': 'Marcin Grabowski, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Warsaw'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Marcin Grabowski', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}