Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-04 @ 10:20 PM
Study NCT ID:
NCT01805804
Status:
TERMINATED
Last Update Posted:
2023-04-12
First Post:
2013-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020257', 'term': 'Ventricular Remodeling'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'whyStopped': 'Recall of some valsartan preparations. 88 patients enrolled and completed the observation. All patients are in continuous observation and are well.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2013-03-02', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in echocardiographically assessed left ventricle dimensions and left ventricle function', 'timeFrame': 'baseline and 12 months'}], 'secondaryOutcomes': [{'measure': 'change in plasma level of matrix metalloproteinase 9', 'timeFrame': 'baseline and 12 months'}, {'measure': 'change in plasma level of NTproBNP', 'timeFrame': 'baseline and 12 months'}, {'measure': 'change in atrial arrhythmia burden assessed from pacemaker memory', 'timeFrame': 'baseline and 12 months'}, {'measure': 'change in the rate of occurrence of any major adverse cardiovascular event', 'timeFrame': '2 weeks, 3 months, 6 months, 9 months and 12 months'}, {'measure': 'change in plasma level of tissue necrosis factor alpha', 'timeFrame': 'baseline and 12 months'}, {'measure': 'change in plasma level of tissue inhibitor of matrix metalloproteinase 3', 'timeFrame': 'baseline and 12 months'}, {'measure': 'change in distance walked during six minute walking test', 'timeFrame': 'baseline and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dual chamber pacing, left ventricle remodeling, valsartan'], 'conditions': ['First Time Dual Chamber Pacemaker Implantation']}, 'referencesModule': {'references': [{'pmid': '19346662', 'type': 'BACKGROUND', 'citation': 'Suzuki H, Geshi E, Nanjyo S, Nakano H, Yamazaki J, Sato N, Tanaka K, Takano T, Yagi H, Shibata T, Mochizuki S, Katagiri T. Inhibitory effect of valsartan against progression of left ventricular dysfunction after myocardial infarction: T-VENTURE study. Circ J. 2009 May;73(5):918-24. doi: 10.1253/circj.cj-08-0959. Epub 2009 Apr 2.'}, {'pmid': '20378999', 'type': 'BACKGROUND', 'citation': 'Miyazaki S, Kasai T, Miyauchi K, Miyazaki T, Akimoto Y, Takagi A, Aihara K, Kawamura M, Suwa S, Kojima S, Sumiyoshi M, Daida H. Changes of matrix metalloproteinase-9 level is associated with left ventricular remodeling following acute myocardial infarction among patients treated with trandolapril, valsartan or both. Circ J. 2010 Jun;74(6):1158-64. doi: 10.1253/circj.cj-09-0412. Epub 2010 Apr 6.'}, {'pmid': '15486029', 'type': 'BACKGROUND', 'citation': 'Garcia RA, Brown KL, Pavelec RS, Go KV, Covell JW, Villarreal FJ. Abnormal cardiac wall motion and early matrix metalloproteinase activity. Am J Physiol Heart Circ Physiol. 2005 Mar;288(3):H1080-7. doi: 10.1152/ajpheart.00860.2004. Epub 2004 Oct 14.'}, {'pmid': '25858003', 'type': 'DERIVED', 'citation': 'Tomasik A, Jachec W, Wojciechowska C, Kawecki D, Bialkowska B, Romuk E, Gabrysiak A, Birkner E, Kalarus Z, Nowalany-Kozielska E. Randomized placebo controlled blinded study to assess valsartan efficacy in preventing left ventricle remodeling in patients with dual chamber pacemaker--Rationale and design of the trial. Contemp Clin Trials. 2015 May;42:239-43. doi: 10.1016/j.cct.2015.03.015. Epub 2015 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'Dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to heart failure. The investigators aim to test hypothesis that valsartan started immediately after dual chamber pacemaker implantation will prevent left ventricle remodeling in twelve months long follow up in comparison with placebo. Echocardiographic assessment of left ventricle remodeling will be correlated with plasma activity of matrix metalloproteinases and their tissue inhibitors, indices of functional capacity such as plasma level of NTproBNP and distance in meters during six minute walking test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* informed written consent\n* age ≥ 18 years\n* first time pacemaker implantation for trifascicular block, atrioventricular second or third degree block\n* left ventricle ejection fraction ≥ 40%\n\nExclusion Criteria:\n\n* significant valvular heart disease\n* ischaemic heart disease requiring further revascularization\n* symptomatic hypotension\n* orthostatic disorders\n* pregnancy, breast feeding, child bearing potential\n* previous use of angiotensin receptor blocking agents\n* known hypersensitivity to valsartan\n* significant liver disorders\n* significant renal disorders, including renal artery stenosis\n* hyperaldosteronism\n* chronic use of nonsteroid antiinflammatory drugs\n* chronic use of lithium salts\n* Patient's reluctance or disability to obey protocol and/or follow the scheduled visits\n* any significant disease to reduce the expected life duration \\< 12 months\n* participation in any other trial within the last 30 days before randomization\n* any situation that would put more risk on patient"}, 'identificationModule': {'nctId': 'NCT01805804', 'briefTitle': 'Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': 'Randomized, Placebo Controlled Blinded Study to Assess the Efficacy of Valsartan to Prevent Left Ventricle Remodeling in Patients With Dual Chamber Pacemaker', 'orgStudyIdInfo': {'id': '01/2012'}, 'secondaryIdInfos': [{'id': 'KNW-1-154/P/2/0', 'type': 'OTHER_GRANT', 'domain': 'Medical University of Silesia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo pills to match valsartan tablets administered once daily', 'interventionNames': ['Drug: placebo/valsartan']}, {'type': 'EXPERIMENTAL', 'label': 'valsartan 80mg daily', 'description': 'Valsartan 80mg tablet once daily', 'interventionNames': ['Drug: placebo/valsartan']}, {'type': 'EXPERIMENTAL', 'label': 'valsartan 160mg daily', 'description': 'Valsartan 160mg tablet once daily', 'interventionNames': ['Drug: placebo/valsartan']}], 'interventions': [{'name': 'placebo/valsartan', 'type': 'DRUG', 'otherNames': ['Valsartan', 'Other names:', 'Diovan', 'Axudan', 'Vanatex'], 'armGroupLabels': ['Placebo', 'valsartan 160mg daily', 'valsartan 80mg daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41-800', 'city': 'Zabrze', 'state': 'Upper Silesia', 'country': 'Poland', 'facility': 'II Dept. of Cardiology in Zabrze Medical University of Silesia', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}], 'overallOfficials': [{'name': 'Ewa Nowalany-Kozielska, MD PhD Associate Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of Silesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Polpharma Pharmaceutical Company', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Andrzej Tomasik MD PhD FESC', 'investigatorAffiliation': 'Medical University of Silesia'}}}}