{
  "FullStudy":{
    "Rank":217861,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515878",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2019"
          },
          "Organization":{
            "OrgFullName":"Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Hemocontrol's Effectiveness on the Reduction of Cardiovascular Long-term EventS",
          "OfficialTitle":"Hemocontrol's Effectiveness in a RAndomized Controlled Trial on the Reduction of Cardiovascular Long-term EventS",
          "Acronym":"HERACLES"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2015",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2015",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 4, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 6, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Antonio Santoro",
            "ResponsiblePartyInvestigatorTitle":"Professor, MD, Chief of Nephrology",
            "ResponsiblePartyInvestigatorAffiliation":"Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"It is hypothesized that a consistent use of the Hemocontrol TM biofeedback function improves long-term cardiovascular outcome, mediated by reduced hypertension due to fluid overload and by reduced incidence of intradialytic hypotensive episodes"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Kidney Failure Chronic",
              "Cardiovascular Diseases"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"396",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Dialysis with BVT",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Dialysis using the BVT monitor biofeedback called Hemocontrol",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Hemocontrol"
                  ]
                }
              },{
                "ArmGroupLabel":"Conventional dialysis",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"Conventional dialysis without blood volume tracking or similar therapies"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Hemocontrol",
                "InterventionDescription":"Blood Volume Tracking system using biofeedback",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Dialysis with BVT"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Cardiovascular events",
                "PrimaryOutcomeDescription":"The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events",
                "PrimaryOutcomeTimeFrame":"36 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Cardiovascular morbidity",
                "SecondaryOutcomeDescription":"Number of hospital admissions evaluated as annual hospitalization rate related to: Non fatal myocardial infarction, New-onset angina, Non fatal stroke, Congestive heart failure, Transient ischemic attack, Pulmonary oedema\nLength of stay during hospitalization;\nNumber of extra dialysis or prolonged dialysis due to fluid overload.",
                "SecondaryOutcomeTimeFrame":"36 months"
              },{
                "SecondaryOutcomeMeasure":"Blood pressure control",
                "SecondaryOutcomeDescription":"Blood pressure control:\n\nPredialysis blood pressure measurements\nHome blood pressure self assessment\nAntihypertensive therapy changes\nProportion of patients achieving adequate blood pressure control\nIntradialytic acute hypotension:",
                "SecondaryOutcomeTimeFrame":"36 months"
              },{
                "SecondaryOutcomeMeasure":"Quality of life and dialysis tolerance evaluated with questionnaire.",
                "SecondaryOutcomeDescription":"Questions of the KDQOL36 questionnaire",
                "SecondaryOutcomeTimeFrame":"36 months"
              },{
                "SecondaryOutcomeMeasure":"Dry weight management",
                "SecondaryOutcomeDescription":"Optional when available at site: Hydration status estimated by Cardiothoracic index or BNP or BIA at baseline and each 12 months",
                "SecondaryOutcomeTimeFrame":"36 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge more than 65 years old\nArterial Hypertension: predialysis SBP >140 mmHg and/or DBP >90 mmHg in at least 50% over the previous month dialysis sessions or receiving at least one antihypertensive pharmacological drug including diuretics, disregarded blood pressure value\nOn a three times per week hemodialysis schedule\nTime on hemodialysis less than 6 months\nAble to measure their blood pressure at home (by themselves or with the aid of the care giver)\nSigned informed consent\n\nExclusion Criteria:\n\nActive neoplastic disease\nMental illness\nPregnancy\nSingle needle treatment\nInability, as judged by the investigator, to follow or understand the protocol instructions\nBlood flow rate less than 200 mL/min\nPatients who at the time of recruitment need clinical indication for special renal replacement therapies and/or on treatment with one of the following modalities: HDF or similar diffusive-convective therapies, treatment time >5h, blood temperature control, isolated UF profiling of Na/UFR\nPatients with a life expectancy shorter than 6 months\nPatients in a list for transplant within the next 6 months\nPredialysis Hemoglobin level greater than 13.5 g/dl\nHistory of major cardiovascular events during run in period",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Antonio Santoro, Pf",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"+39 051 6362 430",
                "CentralContactEMail":"antonio.santoro@aosp.bo.it"
              },{
                "CentralContactName":"Helena Mancini, MD",
                "CentralContactRole":"Contact",
                "CentralContactEMail":"elena.mancini@aosp.bo.it"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jennifer Mac Rae, MD",
                "OverallOfficialAffiliation":"Calgary hospital, Canada",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Hafedh Fessi, MD",
                "OverallOfficialAffiliation":"APHP Tenon, Paris France",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Juan Buades, MD",
                "OverallOfficialAffiliation":"Majorca hospital, Spain",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Helena Mancini, MD",
                "OverallOfficialAffiliation":"AOSP, Bologna Italy",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Antonio Santoro, Pf",
                "OverallOfficialAffiliation":"AOSP, Bologna Italy",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Health Regional hospital",
                "LocationStatus":"Not yet recruiting",
                "LocationCity":"Calgary",
                "LocationCountry":"Canada",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Jennifer Mac Rae, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactEMail":"jennifer.macrae@calgaryhealthregion.ca"
                    },{
                      "LocationContactName":"Jennifer Mac Rae, MD",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              },{
                "LocationFacility":"Hopital Tenon, APHP",
                "LocationStatus":"Active, not recruiting",
                "LocationCity":"Paris",
                "LocationZip":"75970",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Azienda Ospedaliero-Universitaria di Bologna",
                "LocationStatus":"Recruiting",
                "LocationCity":"Bologna",
                "LocationZip":"40138",
                "LocationCountry":"Italy",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Antonio Santoro, Pf",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"+39 051 63 62 430",
                      "LocationContactEMail":"antonio.santoro@aosp.bo.it"
                    },{
                      "LocationContactName":"Elena Mancini, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactEMail":"elena.mancini@aosp.bo.it"
                    },{
                      "LocationContactName":"Antonio Santoro, Pf",
                      "LocationContactRole":"Principal Investigator"
                    },{
                      "LocationContactName":"Elena Mancini, MD",
                      "LocationContactRole":"Sub-Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000051437",
                "ConditionMeshTerm":"Renal Insufficiency"
              },{
                "ConditionMeshId":"D000007676",
                "ConditionMeshTerm":"Kidney Failure, Chronic"
              },{
                "ConditionMeshId":"D000002318",
                "ConditionMeshTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000007674",
                "ConditionAncestorTerm":"Kidney Diseases"
              },{
                "ConditionAncestorId":"D000014570",
                "ConditionAncestorTerm":"Urologic Diseases"
              },{
                "ConditionAncestorId":"D000051436",
                "ConditionAncestorTerm":"Renal Insufficiency, Chronic"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M25305",
                "ConditionBrowseLeafName":"Renal Insufficiency",
                "ConditionBrowseLeafAsFound":"Kidney Failure",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9282",
                "ConditionBrowseLeafName":"Kidney Failure, Chronic",
                "ConditionBrowseLeafAsFound":"Kidney Failure Chronic",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9281",
                "ConditionBrowseLeafName":"Kidney Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15902",
                "ConditionBrowseLeafName":"Urologic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M25304",
                "ConditionBrowseLeafName":"Renal Insufficiency, Chronic",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}