{ "FullStudy":{ "Rank":217689, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518114", "OrgStudyIdInfo":{ "OrgStudyId":"SHEBA-10-8081-MA-CTIL" }, "Organization":{ "OrgFullName":"Sheba Medical Center", "OrgClass":"OTHER_GOV" }, "BriefTitle":"Exercise Training in Patients With Hypertrophic Cardiomyopathy" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2013", "PrimaryCompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 26, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 31, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Dr. Michael Arad", "ResponsiblePartyInvestigatorTitle":"MD", "ResponsiblePartyInvestigatorAffiliation":"Sheba Medical Center" }, "LeadSponsor":{ "LeadSponsorName":"Sheba Medical Center", "LeadSponsorClass":"OTHER_GOV" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Exercise training (ET) is highly beneficial in heart failure patients and has been suggested to confer significant symptomatic and functional improvements in patients with diastolic dysfunction. Accordingly, the aim of this study was to examine the safety, feasibility of a structured ET program in symptomatic HCM patients." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hypertrophic Cardiomyopathy" ] }, "KeywordList":{ "Keyword":[ "Hypertrophic Cardiomyopathy", "Exercise Training", "Cardiac Rehabilitation", "Heart Failure" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"60", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Exercise Training", "ArmGroupType":"Experimental", "ArmGroupDescription":"Exercise will be performed under continuous telemetry monitoring and medical supervision. Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise. Blood pressure will be obtained before the onset and at the end of each session. Participants will be requested to rest and observed 15-30 min before going home. The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale.\n\nExercise prescription will be based upon cardiopulmonary test done at baseline.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Exercise Training" ] } },{ "ArmGroupLabel":"Best Medical Care", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Advanced HCM patients who are eligible to participate in the study but cannot do so for technical reasons will be invited to participate in the project as a control group.These subjects will continue their regular follow up in the Cardiomyopathy Clinic and their usual voluntary physical activity at home.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Exercise Training" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Exercise Training", "InterventionDescription":"Exercise will be performed under continuous telemetry monitoring and medical supervision. Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise. Blood pressure will be obtained before the onset and at the end of each session. Participants will be requested to rest and observed 15-30 min before going home. The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Best Medical Care", "Exercise Training" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation", "PrimaryOutcomeDescription":"End point to be assessed by cardiopulmonary testing are pre- and post exercise training improvement as expressed by the changes in : VO2 MAX, exercise duration, duration to ventilatory threshold(VT).", "PrimaryOutcomeTimeFrame":"6 months" },{ "PrimaryOutcomeMeasure":"Safety of exercise training in patients with symptomatic hypertrophic cardiomyopathy", "PrimaryOutcomeDescription":"Safety endpoonts: 1) Clinicaly significant arrhythmia during exercise training 2)MACE during follow-up period (ACS, Stroke or Death) 3)Exercise Related Injury 4) Episodes of syncope", "PrimaryOutcomeTimeFrame":"12 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Secondary Endpoints:", "SecondaryOutcomeDescription":"The effect on quality of life\nThe change in maximal wall thickness, LVEF, resting and exercise-induced left ventricular outflow gradient and pulmonary artery pressure (stress echo).\nResting BNP and troponin I levels", "SecondaryOutcomeTimeFrame":"12 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHypertrophic Cardiomyopathy\nNYHA 3\nMaximal left ventricular wall thickness > 20 mm\nAge >18\n\nExclusion Criteria:\n\nSevere non-cardiac limitations of functional capacity such as neurological illness, lung disease, peripheral vascular or orthopedic problem, etc.\nPatients state post resuscitation for malignant ventricular arrhythmia.\nHistory of effort induced syncope, complex ventricular arrhythmia or atrial fibrillation.\nAn exercise-induced decrease in blood pressure\nSevere left ventricular outflow obstruction defined as resting outflow gradient > 50 mmHg on maximal therapy\nAtrial fibrillation with a poorly controlled ventricular response\nAdvanced hypokinetic stage of HCM defined as LVEF < 40%\nCongestive heart failure of angina FC IV according to NYHA or CCS respectively.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Arad Michael, MD", "CentralContactRole":"Contact", "CentralContactEMail":"Michael.Arad@sheba.health.gov.il" },{ "CentralContactName":"Robert Klempfner, MD", "CentralContactRole":"Contact", "CentralContactPhone":"+972525506852", "CentralContactEMail":"klempfner@gmail.com" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Sheba Medical Center", "LocationStatus":"Recruiting", "LocationCity":"Tel Hashomer , Ramat Gan", "LocationCountry":"Israel", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Robert Klempfner, MD", "LocationContactRole":"Contact", "LocationContactPhone":"+972525506852", "LocationContactEMail":"klempfner@gmail.com" },{ "LocationContactName":"Arad Michael, MD", "LocationContactRole":"Principal Investigator" },{ "LocationContactName":"Tamir Kamerman, MS", "LocationContactRole":"Sub-Investigator" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009202", "ConditionMeshTerm":"Cardiomyopathies" },{ "ConditionMeshId":"D000002312", "ConditionMeshTerm":"Cardiomyopathy, Hypertrophic" },{ "ConditionMeshId":"D000006984", "ConditionMeshTerm":"Hypertrophy" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000006331", "ConditionAncestorTerm":"Heart Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000020763", "ConditionAncestorTerm":"Pathological Conditions, Anatomical" },{ "ConditionAncestorId":"D000001020", "ConditionAncestorTerm":"Aortic Stenosis, Subvalvular" },{ "ConditionAncestorId":"D000001024", "ConditionAncestorTerm":"Aortic Valve Stenosis" },{ "ConditionAncestorId":"D000006349", "ConditionAncestorTerm":"Heart Valve Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M10737", "ConditionBrowseLeafName":"Cardiomyopathies", "ConditionBrowseLeafAsFound":"Cardiomyopathy", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4150", "ConditionBrowseLeafName":"Cardiomyopathy, Hypertrophic", "ConditionBrowseLeafAsFound":"Hypertrophic Cardiomyopathy", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8618", "ConditionBrowseLeafName":"Hypertrophy", "ConditionBrowseLeafAsFound":"Hypertrophic", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8004", "ConditionBrowseLeafName":"Heart Failure", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8002", "ConditionBrowseLeafName":"Heart Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M21103", "ConditionBrowseLeafName":"Pathological Conditions, Anatomical", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5058", "ConditionBrowseLeafName":"Constriction, Pathologic", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M2921", "ConditionBrowseLeafName":"Aortic Valve Stenosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8020", "ConditionBrowseLeafName":"Heart Valve Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T450", "ConditionBrowseLeafName":"Aortic Valve Stenosis", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }