Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT03587558
Status:
UNKNOWN
Last Update Posted:
2018-07-18
First Post:
2018-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Carvedilol on Suppressing the Premature Ventricular Complex/Ventricular Tachycardia From Outflow Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018879', 'term': 'Ventricular Premature Complexes'}], 'ancestors': [{'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077261', 'term': 'Carvedilol'}, {'id': 'D005424', 'term': 'Flecainide'}], 'ancestors': [{'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': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2018-07-02', 'studyFirstSubmitQcDate': '2018-07-02', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PVC burden', 'timeFrame': '3 months after reaching the maximum tolerated dose', 'description': 'Percentage of PVC/VT beat out of 24 hour total heart beat in Holter monitoring'}], 'secondaryOutcomes': [{'measure': 'Symptom assessment scale', 'timeFrame': '3 months after reaching the maximum tolerated dose', 'description': 'questionnaire for PVC/VT symptoms using symptom assessment scale (Min 0 to Max 100)'}, {'measure': 'Side effect of drugs', 'timeFrame': '3 months after reaching the maximum tolerated dose', 'description': 'Difference in occurrence of side effects of each drug'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carvedilol', 'SOICR', 'triggered activity', 'outflow tract PVC/VT'], 'conditions': ['Ventricular Premature Complexes', 'Outflow Tract', 'Carvedilol']}, 'descriptionModule': {'briefSummary': 'Carvedilol is known to be effective in reducing ventricular arrhythmias and mortality in patients with heart failure. It is suggested that one of the mechanisms is its ability to block store overload-induced Calcium release which activates spontaneous calcium release by Ryanodine receptors. Ventricular outflow tract tachyarrhythmia is known to be associated with calcium overload due to activation of Ryanodine receptors. The aim of this study is to evaluate the efficacy of Carvedilol on premature ventricular complex(PVC)/ventricular tachycardia(VT) originating from outflow tract.', 'detailedDescription': 'Carvedilol is one of the third-generation beta-blockers effective in reducing ventricular arrhythmias and mortality in patients with heart failure. Antioxidative and alpha - blocking effects, along with nonselective beta - blockade, have been described as a mechanism of effect in various diseases.\n\nThe antiarrhythmic effect of carvedilol inhibiting atrial fibrillation or ventricular arrhythmia has been reported, but its mechanism is not yet clear. Among them, inhibition of store overload-induced Ca2+ release (SOICR) is suggested as an antiarrhythmic mechanism of carvedilol.\n\nStimulation of the beta receptor leads to the entry of calcium into the sarcoplasmic reticulum (SR) by opening the L-type calcium channel. The influx of calcium through the L-type calcium channel also increases the calcium release through the Ryanodine receptor (RyR) in the sarcoplasmic reticulum. This is called Ca-induced Ca release and is known as a normal physiological response. However, when calcium overload in the myofibrillar body occurs, spontaneous calcium release, known as SOICR, can occur through RyR, which can make triggered activity by inducing Na+/Ca2+ exchanger present in myocardium, leading to severe arrhythmia. Among several beta-blockers, only carvedilol has been known as a drug that can directly inhibit SOICR in combination with beta-blockade effect.\n\nVentricular tachyarrhythmia originating from the ventricular outflow tract is an arrhythmia occurring in a patient with normal cardiac function. The mechanism of the arrhythmia is known to be triggered activity which is caused by activation of RyR due to increased cyclic adenosine monophasphate, resulting in calcium overload, eventually causing activation of Na+/Ca2+ exchanger. The aim of this study is to evaluate the efficacy of Carvedilol on PVC/VT originating from outflow tract.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ventricular premature complexes/ventricular tachycardias originating from ventricular outflow tract confirmed on the 12-lead surface ECG\n* Patients with PVC burden of 5% or more in 24-hour Holter monitoring\n* Patients with normal left ventricular function\n\n * left ventricular ejection fraction ≥50%\n* Patients without structural heart disease\n\nExclusion Criteria:\n\n* Pregnant, trying to become pregnant or breast feeding\n* History of bronchial asthma\n* History of coronary arterial disease'}, 'identificationModule': {'nctId': 'NCT03587558', 'acronym': 'FOREVER', 'briefTitle': 'Effects of Carvedilol on Suppressing the Premature Ventricular Complex/Ventricular Tachycardia From Outflow Tract', 'organization': {'class': 'OTHER', 'fullName': 'Keimyung University Dongsan Medical Center'}, 'officialTitle': 'Effects of Carvedilol on Suppressing the Premature Ventricular Complex/Ventricular Tachycardia From Outflow Tract', 'orgStudyIdInfo': {'id': '2017-07-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carvedilol group', 'description': 'Patients in this group are taking carvedilol to inhibit outflow tract PVC/VT. Dilatrend® sustained release form of Chong Kun Dang Pharmaceutical will be used (initial dose: 8 mg sustained release form). Outpatient follow-up will be performed every 2 weeks and the dose is increased from the initial dose to a maximal tolerable dose, at the discretion of the investigator.', 'interventionNames': ['Drug: Carvedilol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flecainide group', 'description': 'Patients in this group are taking flecainide to inhibit outflow tract PVC/VT. Tambocor® of JW Pharmaceutical will be used. Outpatient follow-up will be performed every 2 weeks and the dose is increased from the initial dose to a maximal tolerable dose, at the discretion of the investigator.', 'interventionNames': ['Drug: Flecainide']}], 'interventions': [{'name': 'Carvedilol', 'type': 'DRUG', 'otherNames': ['Dilatrend'], 'description': 'Patients in this group are taking carvedilol to inhibit outflow tract PVC/VT.', 'armGroupLabels': ['Carvedilol group']}, {'name': 'Flecainide', 'type': 'DRUG', 'otherNames': ['Tambocor'], 'description': 'Patients in this group are taking flecainide to inhibit outflow tract PVC/VT.', 'armGroupLabels': ['Flecainide group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41931', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jongmin Hwang, M.D.', 'role': 'CONTACT', 'email': 'dsmcep@dsmc.or.kr', 'phone': '+82-53-250-7333'}, {'name': 'Seongwook Han, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yoon-Nyun Kim, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hyoung-Seob Park, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jongmin Hwang, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '41944', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Myung Hwan Bae, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42415', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong Gu Shin, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42472', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Soo Lee, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '61469', 'city': 'Gwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyung Wook Park, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '02841', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong-Il Choi, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eue-Keun Choi, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Boyoung Joung, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Severance Cardiovascular Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jun Kim, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Seoul Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Keun On, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Seoul Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung-Hwan Kim', 'role': 'CONTACT'}], 'facility': "Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jongmin Hwang, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'dsmcep@dsmc.or.kr', 'phone': '+82-53-250-7333'}], 'overallOfficials': [{'name': 'Seongwook Han, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Keimyung University Dongsan Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available within 6 months of study completion.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcome measures will be made available.', 'accessCriteria': 'Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chong Kun Dang Pharmaceutical Corp.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}