{
  "FullStudy":{
    "Rank":217709,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517854",
          "OrgStudyIdInfo":{
            "OrgStudyId":"RePo1"
          },
          "Organization":{
            "OrgFullName":"University Health Network, Toronto",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Revatio Portal-Pulmonary Arterial Hypertension Trial",
          "OfficialTitle":"Revatio Portal-Pulmonary Arterial Hypertension Trial (RePo1 Trial): A Randomized, Double-blinded, Placebo-controlled, Multi-center Study to Evaluate the Effects of Sildenafil Citrate (Revatio) 20 mg TID on Patients With Portal Pulmonary Arterial Hypertension (PPAH)",
          "Acronym":"RePo1"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2019",
          "OverallStatus":"Terminated",
          "WhyStopped":"Poor recruitment.",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 14, 2012",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"October 30, 2017",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 14, 2019",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 14, 2011",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 25, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 27, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University Health Network, Toronto",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes",
          "IsFDARegulatedDrug":"No",
          "IsFDARegulatedDevice":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The investigators propose the first prospective, double blind, randomized controlled trial of treatment for pulmonary arterial hypertension (PAH) related to underlying portal hypertension. Specifically the investigators will evaluate the potential efficacy and safety of sildenafil (Revatio) in a 16 week blinded, multicentre study.",
          "DetailedDescription":"PAH is a recognized complication of portal hypertension - termed portal-pulmonary hypertension (PPHTN). In the World Health Organization (WHO) classification PPHTN is categorized as a WHO group 1 condition. This categorization is appropriate as PPHTN shares similar pathological features and clinical presentation and as idiopathic (primary) pulmonary arterial hypertension (PAH). Advances in oral therapies in PAH (idiopathic, connective tissue disease, congenital heart disease) has deferred the need for parenteral therapies, lung transplantation and led to improvements in functional capacity, quality of life and survival. However unlike other forms of PAH, treatment options have not been formally evaluated for PPHTN and there are no approved medical therapies. Patients are unable to pay for medications. Consequently patients continue to endure the natural progression of PAH - a state characterized by progressive right heart failure, disability and death. Furthermore the unacceptable mortality associated with liver transplantation in the presence of hemodynamically significant PAH, leaves them with no therapeutic options. Therefore, new treatment options need to be systematically evaluated."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Portopulmonary Hypertension"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"12",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Revatio",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Sildenafil"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Sildenafil",
                "InterventionDescription":"20 mg Revatio (sildenafil citrate) three times a day",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Revatio"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Placebo",
                "InterventionDescription":"Placebo identical to Revatio (sildenafil citrate) three times a day",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change from baseline in PVR after 16 weeks of treatment",
                "PrimaryOutcomeTimeFrame":"16 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"For patients with a PVR>450 dynes/sec/cm5 at baseline, number of patients who have PVR below 350 dynes/sec/cm5 after 16 weeks of study drug will be determined",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              },{
                "SecondaryOutcomeMeasure":"Hospitalizations",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              },{
                "SecondaryOutcomeMeasure":"Death",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              },{
                "SecondaryOutcomeMeasure":"Complications of liver disease",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              },{
                "SecondaryOutcomeMeasure":"MELD score",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              },{
                "SecondaryOutcomeMeasure":"Renal dysfunction",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              },{
                "SecondaryOutcomeMeasure":"Desaturation",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in 6MWD from baseline",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in baseline WHO functional class",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in Brain Natruretic Peptide (BNP) from baseline",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              },{
                "SecondaryOutcomeMeasure":"Change from baseline in CAMPHOR and SF-36 measures of quality of life",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMale and female patients with PPHTN.\nA 6MWD test between 150 m and 450 m.\nA pulmonary vascular resistance (PVR) >250 dyn*sec*cm-5, a mean pulmonary artery pressure (PAPmean) ≥25 mmHg due to portal hypertension, and PCWP ≤ 15 mmHg. Right-heart catheterization results for the definite diagnosis of PH must follow the 2 - 6 week pre-treatment phase and not be older than 6 weeks at study start (will be considered as baseline values).\nPortal hypertension defined either clinically or hemodynamically by the presence of cirrhosis (by ultrasound or biopsy) or portal vein thrombosis / obstruction (proven by portal vein Doppler) and any one of the following within one year of entry into the study: 1) Ascites (on ultrasound of the abdomen); 2) Splenomegaly (on ultrasound of the abdomen); 3) Esophageal or Gastric Varices (proven endoscopically); 4) Hepatic-venous pressure gradient (HVPG) > 12 mmHg.\nTreatment naive patients (with respect to PAH specific medication) and patients. Prior use of sildenafil for erectile dysfunction will be permitted.\n18 to 75 years of age at Visit 1.\nPatients who are able to understand and follow instructions and who are able to participate in the study for the entire period.\nPatients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures.\n\nExclusion Criteria:\n\nParticipation in another clinical trial during the preceding 3 months.\nPregnant women or breast feeding women.\nPatients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator or the sponsor.\nPatients with a history of severe allergies or multiple drug allergies.\nPatients with hypersensitivity to the investigational drug or inactive constituents.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"75 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"John T Granton",
                "OverallOfficialAffiliation":"University Health Network, Toronto",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Lawson Health Research Institute (London Health Sciences Centre Research Inc.)",
                "LocationCity":"London",
                "LocationState":"Ontario",
                "LocationZip":"N6C 2R5",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"University Health Network",
                "LocationCity":"Toronto",
                "LocationState":"Ontario",
                "LocationZip":"M5G 2N2",
                "LocationCountry":"Canada"
              },{
                "LocationFacility":"Institut universitaire de cardiologie et de pneumologie de Québec",
                "LocationCity":"Québec",
                "LocationZip":"G1V 4G5",
                "LocationCountry":"Canada"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000068677",
                "InterventionMeshTerm":"Sildenafil Citrate"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000014665",
                "InterventionAncestorTerm":"Vasodilator Agents"
              },{
                "InterventionAncestorId":"D000058986",
                "InterventionAncestorTerm":"Phosphodiesterase 5 Inhibitors"
              },{
                "InterventionAncestorId":"D000010726",
                "InterventionAncestorTerm":"Phosphodiesterase Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000064804",
                "InterventionAncestorTerm":"Urological Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M292",
                "InterventionBrowseLeafName":"Sildenafil Citrate",
                "InterventionBrowseLeafAsFound":"Sildenafil",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M19904",
                "InterventionBrowseLeafName":"Citric Acid",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M1837",
                "InterventionBrowseLeafName":"Sodium Citrate",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M15995",
                "InterventionBrowseLeafName":"Vasodilator Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M27919",
                "InterventionBrowseLeafName":"Phosphodiesterase 5 Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M12212",
                "InterventionBrowseLeafName":"Phosphodiesterase Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"T382",
                "InterventionBrowseLeafName":"Citrate",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"VaDiAg",
                "InterventionBrowseBranchName":"Vasodilator Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Urol",
                "InterventionBrowseBranchName":"Urological Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"AnCoag",
                "InterventionBrowseBranchName":"Anticoagulants"
              },{
                "InterventionBrowseBranchAbbrev":"Ot",
                "InterventionBrowseBranchName":"Other Dietary Supplements"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006973",
                "ConditionMeshTerm":"Hypertension"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014652",
                "ConditionAncestorTerm":"Vascular Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8607",
                "ConditionBrowseLeafName":"Hypertension",
                "ConditionBrowseLeafAsFound":"Hypertension",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M15983",
                "ConditionBrowseLeafName":"Vascular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T4833",
                "ConditionBrowseLeafName":"Pulmonary Arterial Hypertension",
                "ConditionBrowseLeafAsFound":"Pulmonary Arterial Hypertension",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}