{ "FullStudy":{ "Rank":218292, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510210", "OrgStudyIdInfo":{ "OrgStudyId":"NHS2010B233" }, "Organization":{ "OrgFullName":"University Medical Center Groningen", "OrgClass":"OTHER" }, "BriefTitle":"Risk Profile for Patients With Atrial Fibrillation", "OfficialTitle":"Identification of a Risk Profile to Guide Atrial Fibrillation Therapy" }, "StatusModule":{ "StatusVerifiedDate":"October 2018", "OverallStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2011", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"March 2021", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"March 2021", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"December 28, 2011", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 16, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"October 26, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 29, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor-Investigator", "ResponsiblePartyInvestigatorFullName":"I.C. Van Gelder", "ResponsiblePartyInvestigatorTitle":"MD. PhD", "ResponsiblePartyInvestigatorAffiliation":"University Medical Center Groningen" }, "LeadSponsor":{ "LeadSponsorName":"I.C. Van Gelder", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Netherlands Heart Foundation", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The objective of this study is to assess the risk profile in patients with atrial fibrillation, which represents the degree of changes in the atrial tissue and which can help predict in which patients rhythm control will be successful. This risk profile will consist of a combination of underlying (heart) disease and risk factors, measurements obtained from echocardiograms, and circulating biomarkers. Ultimately this risk profile can be used to guide type of rhythm control therapy in individual patients with atrial fibrillation.", "DetailedDescription":"Atrial fibrillation is responsible for substantial morbidity and mortality.Identification of patients with atrial fibrillation that is difficult to treat may improve the outcome of rhythm control therapy. Left atrial size could be a useful tool to select patients that will benefit from rhythm control therapy.Beside echocardiographic parameters,atrial fibrillation has been also associated with circulating biomarkers in blood like collagen metabolism, inflammatory mediators,neurohumoral factors and proteins/proteomic profiles. Beside more accepted risk factors (myocardial ischemia, diabetes and pulmonary disease)other less well-known clinical factors (sleep apnea, alcohol or other intoxication abuse, excessive physical activity, esophageal problems and increased body mass index) may also predict the outcome of rhythm control.It likes also plausible that recurrent atrial fibrillation within one month after start of rhythm control are associated with a different risk profile than late atrial fibrillation recurrence.During this study we will try to identify patients with atrial fibrillation who are more or less likely to respond to rhythm control therapy." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Atrial Fibrillation" ] }, "KeywordList":{ "Keyword":[ "Atrial Fibrillation", "Arrhythmia", "Rhythm control" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Case-Only" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "BioSpec":{ "BioSpecRetention":"Samples With DNA", "BioSpecDescription":"Serum and plasma stored at -80 degrees Celcius. If informed consent was obtained, DNA extraction has been performed." }, "EnrollmentInfo":{ "EnrollmentCount":"500", "EnrollmentType":"Actual" } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Success of rhythm control", "PrimaryOutcomeDescription":"(1) < 1 second AF on end-of-study ECG; (2) < 30 seconds AF on end-of-study 48-hour Holter recording; (3) no AF on end-of-study 2 weeks Vitaphone ECG-card recording.", "PrimaryOutcomeTimeFrame":"12 month" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Time to recurrence of (a)symptomatic AF", "SecondaryOutcomeDescription":"by assessment Percentage AF-burden on 24-holter during follow up", "SecondaryOutcomeTimeFrame":"1+3+6+9+12 month" },{ "SecondaryOutcomeMeasure":"Failure of rhythm control, i.e. permanent AF", "SecondaryOutcomeDescription":"failure of rhythm control medication or electric cardioversion.", "SecondaryOutcomeTimeFrame":"1+3+6+9+12 month" },{ "SecondaryOutcomeMeasure":"Risk profiles associated with early versus late AF recurrence", "SecondaryOutcomeDescription":"These parameters include underlying (heart) disease and risk factors (including age, family history for AF, signs of ischemia, coronary risk factors, pulmonary disease, diabetes, obesity, sleep apnea, esophageal problems), lifestyle (including caffeine and alcohol intake, exercise), autonomic trigger patterns of AF (i.e. vagal or adrenergic induced AF, or combination", "SecondaryOutcomeTimeFrame":"1month and 12 month" },{ "SecondaryOutcomeMeasure":"Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF", "SecondaryOutcomeDescription":"clinical commplaints and 3-lead Holter monitoring will be used for assessing the onset of AF episode", "SecondaryOutcomeTimeFrame":"1+3+6+9+12 month" },{ "SecondaryOutcomeMeasure":"Changes in atrial and ventricular echocardiographic parameters", "SecondaryOutcomeDescription":"Echocardiographic measures of LA size (LA size parasternal long axis view, LA volume,LA ejection fraction measurement, electro-echocardiographic parameters (Tissue Doppler total atrial conduction time (during sinus rhythm), AF cycle length and velocity (during AF)), and parameters of diastolic dysfunction, including E (early mitral valve flow velocity), A (late mitral valve flow velocity), E/A ratio, deceleration time, E' (early tissue Doppler lengthening velocity), and E/E' ratio", "SecondaryOutcomeTimeFrame":"1month and 12 month" },{ "SecondaryOutcomeMeasure":"Cardiovascular morbidity and mortality", "SecondaryOutcomeDescription":"hospitalization for cardiovascular reasons, non-cardiovascular and cardiovascular death will be carefully monitored through-out the study.", "SecondaryOutcomeTimeFrame":"1month and 12month" },{ "SecondaryOutcomeMeasure":"Pulmonary vein ablation", "SecondaryOutcomeDescription":"hospital admission for pulmonary vein ablation will be monitoring during the study.", "SecondaryOutcomeTimeFrame":"1month, 3month, 6month, 9 month, 12month" },{ "SecondaryOutcomeMeasure":"Pathophysiological mechanisms associated with AF and success of rhythm control", "SecondaryOutcomeDescription":"To study pathophysiological mechanisms of AF, e.g. collagen mediated or inflammation mediated AF", "SecondaryOutcomeTimeFrame":"baseline-12 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nShort-lasting symptomatic paroxysmal or persistent AF;\nRhythm control strategy is preferred;\nNo contra-indication for oral anticoagulation;\nAge > 18 years;\nWritten informed consent\n\nExclusion Criteria:\n\nTotal history of heart failure and/ or of severe valvular disease > 3 years;\nSevere valvular disease;\nAcute coronary syndrome/ myocardial infarction/ percutaneous coronary intervention/ coronary artery bypass surgery within the past one month;\nPost-operative AF.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"Patients with short-lasting symptomatic paroxysmal or persistent AF", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Harry Crijns, MD PhD", "OverallOfficialAffiliation":"Maastricht University Medical Center", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Isabelle C Van Gelder, MD PhD", "OverallOfficialAffiliation":"University Medical Center Groningen", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University Medical Center Groningen", "LocationCity":"Groningen", "LocationZip":"9713 GZ Groningen", "LocationCountry":"Netherlands" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"31865391", "ReferenceType":"derived", "ReferenceCitation":"De With RR, Marcos EG, Dudink EAMP, Spronk HM, Crijns HJGM, Rienstra M, Van Gelder IC. Atrial fibrillation progression risk factors and associated cardiovascular outcome in well-phenotyped patients: data from the AF-RISK study. Europace. 2020 Mar 1;22(3):352-360. doi: 10.1093/europace/euz339." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Undecided" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001281", "ConditionMeshTerm":"Atrial Fibrillation" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001145", "ConditionAncestorTerm":"Arrhythmias, Cardiac" },{ "ConditionAncestorId":"D000006331", "ConditionAncestorTerm":"Heart Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3034", "ConditionBrowseLeafName":"Arrhythmias, Cardiac", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3167", "ConditionBrowseLeafName":"Atrial Fibrillation", "ConditionBrowseLeafAsFound":"Atrial Fibrillation", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8002", "ConditionBrowseLeafName":"Heart Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }