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Source1

{
  "resourceType": "ResearchStudy",
  "id": "588219",
  "meta": {
    "versionId": "9",
    "lastUpdated": "2026-08-07T17:15:50.878Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/study-component"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
            "code": "active",
            "display": "Active"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-author",
      "valueContactDetail": {
        "name": "Khalid Shahin"
      }
    },
    {
      "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sae-reporting-method",
      "valueString": "Report serious adverse events to the coordinating centre within 24 hours of first awareness using the electronic SAE form. The coordinating centre forwards reports to the independent Data and Safety Monitoring Board and to the relevant regulatory authority within 7 calendar days for fatal or life-threatening events, and within 15 calendar days otherwise."
    },
    {
      "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement",
      "valueString": "This study does not have a confidentiality statement, but this is an example of how the data would appear if there was such a statement."
    }
  ],
  "url": "https://fevir.net/resources/ResearchStudy/588219",
  "identifier": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code": "ACSN",
            "display": "Accession ID"
          }
        ],
        "text": "FEvIR Object Identifier"
      },
      "system": "https://fevir.net/FOI",
      "value": "588219",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "title": "BP-CONTROL Cardiovascular Outcomes Component: intensive versus standard blood-pressure control in adults at increased cardiovascular risk",
  "label": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/title-type",
            "code": "acronym",
            "display": "Acronym"
          }
        ]
      },
      "value": "BP-CONTROL-CV",
      "language": "en"
    }
  ],
  "partOf": [
    {
      "reference": "ResearchStudy/588222",
      "display": "BP-CONTROL Master Protocol: blood-pressure targets in adults at increased cardiovascular risk"
    }
  ],
  "citeAs": "BP-CONTROL Cardiovascular Outcomes Component: intensive versus standard blood-pressure control in adults at increased cardiovascular risk [Database Entry: FHIR ResearchStudy Resource]. Contributors: Khalid Shahin [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 588219. Revised 2026-08-07. Available at: https://fevir.net/resources/ResearchStudy/588219. Computable resource at: https://fevir.net/resources/ResearchStudy/588219#json.",
  "relatesTo": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/artifact-relationship-type",
            "code": "part-of",
            "display": "Part Of"
          }
        ]
      },
      "targetReference": {
        "reference": "ResearchStudy/588222",
        "display": "BP-CONTROL Master Protocol: blood-pressure targets in adults at increased cardiovascular risk"
      }
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation",
          "valueMarkdown": "Enrolment was extended by 11 months relative to the original protocol following slower than anticipated recruitment during 2020."
        }
      ],
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/artifact-relationship-type",
            "code": "amended-with",
            "display": "Amended With"
          }
        ]
      },
      "targetMarkdown": "An extension to the enrollment to get enough recruitment."
    }
  ],
  "status": "active",
  "purposeType": [
    {
      "coding": [
        {
          "system": "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type",
          "code": "treatment",
          "display": "Treatment"
        }
      ]
    },
    {
      "coding": [
        {
          "system": "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type",
          "code": "prevention",
          "display": "Prevention"
        }
      ]
    }
  ],
  "phase": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "code": "phase-3",
        "display": "Phase 3"
      }
    ]
  },
  "studyDesign": [
    {
      "text": "Randomized controlled trial"
    }
  ],
  "condition": [
    {
      "coding": [
        {
          "system": "http://snomed.info/sct",
          "code": "38341003",
          "display": "Hypertensive disorder, systemic arterial"
        }
      ],
      "text": "Hypertension with increased cardiovascular risk"
    }
  ],
  "keyword": [
    {
      "text": "blood pressure"
    },
    {
      "text": "cardiovascular prevention"
    },
    {
      "text": "treatment target"
    }
  ],
  "region": [
    {
      "coding": [
        {
          "system": "urn:iso:std:iso:3166",
          "code": "US",
          "display": "United States of America"
        }
      ]
    },
    {
      "coding": [
        {
          "system": "urn:iso:std:iso:3166",
          "code": "CA",
          "display": "Canada"
        }
      ]
    }
  ],
  "descriptionSummary": "Randomized comparison of intensive versus standard blood-pressure control in adults aged 50 years or older with hypertension and at least one additional cardiovascular risk factor, conducted as one component of the BP-CONTROL master protocol.",
  "description": "This ResearchStudy describes one component of a multi-part investigation conducted under the BP-CONTROL master protocol. Participants aged 50 years or older with a systolic blood pressure of 130-180 mmHg and at least one additional cardiovascular risk factor were randomly assigned in a 1:1 ratio to a systolic blood-pressure target of less than 120 mmHg (intensive control) or less than 140 mmHg (standard control).\n\nTreatment was open-label; all primary and secondary endpoint events were adjudicated by a committee unaware of treatment assignment. The primary endpoint was a composite of myocardial infarction, other acute coronary syndrome, stroke, acute decompensated heart failure, or death from cardiovascular causes. Participants were followed until the common study end date or death.\n\nOther components conducted under the same master protocol, and reported separately, address cognitive outcomes and kidney outcomes. Each component is represented as its own ResearchStudy pointing at the shared master protocol through `partOf`.",
  "period": {
    "start": "2019-11-01",
    "end": "2025-10-31"
  },
  "associatedParty": [
    {
      "name": "Example National Heart Institute",
      "role": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-party-role",
            "code": "lead-sponsor",
            "display": "Lead sponsor"
          }
        ]
      },
      "period": [
        {
          "start": "2019-10-01",
          "end": "2025-10-31"
        }
      ]
    },
    {
      "name": "Example Independent Data Monitoring Committee",
      "role": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-party-role",
            "code": "data-monitoring",
            "display": "Data Monitoring"
          }
        ]
      }
    },
    {
      "name": "Example University Clinical Coordinating Centre",
      "role": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-party-role",
            "code": "collaborator",
            "display": "collaborator"
          }
        ]
      },
      "classifier": [
        {
          "coding": [
            {
              "system": "http://hl7.org/fhir/research-study-party-organization-type",
              "code": "academic",
              "display": "Academic"
            }
          ]
        }
      ]
    }
  ],
  "progressStatus": [
    {
      "state": {
        "text": "Recruitment complete"
      },
      "actual": true,
      "period": {
        "start": "2021-10-04"
      }
    },
    {
      "state": {
        "text": "Follow-up complete"
      },
      "actual": true,
      "period": {
        "start": "2025-11-01"
      }
    }
  ],
  "recruitment": {
    "targetNumber": 9200,
    "actualNumber": 9361,
    "description": "Recruitment was conducted at 102 sites in the United States and Canada. Screening ran from November 2019 to October 2021."
  },
  "comparisonGroup": [
    {
      "targetNumber": 4600,
      "actualNumber": 4678,
      "name": "Intensive control",
      "description": "Antihypertensive therapy titrated at monthly intervals to a systolic blood-pressure target of less than 120 mmHg."
    },
    {
      "targetNumber": 4600,
      "actualNumber": 4683,
      "name": "Standard control",
      "description": "Antihypertensive therapy titrated to a systolic blood-pressure target of less than 140 mmHg."
    }
  ],
  "objective": [
    {
      "name": "Primary objective",
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "primary",
            "display": "Primary"
          }
        ]
      },
      "description": "To determine whether a systolic blood-pressure target of less than 120 mmHg reduces the rate of major adverse cardiovascular events compared with a target of less than 140 mmHg.",
      "outcomeMeasure": [
        {
          "name": "Major adverse cardiovascular events",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "primary",
                "display": "Primary"
              }
            ]
          },
          "description": "Time to first occurrence of myocardial infarction, other acute coronary syndrome, stroke, acute decompensated heart failure, or death from cardiovascular causes, adjudicated by a committee unaware of treatment assignment.",
          "endpoint": {
            "reference": "EvidenceVariable/588221",
            "display": "Major adverse cardiovascular events (composite endpoint)"
          },
          "summaryMeasure": {
            "text": "Hazard ratio from a Cox proportional-hazards model stratified by site"
          }
        }
      ]
    },
    {
      "name": "Safety objective",
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
          }
        ]
      },
      "description": "To compare the rate of serious adverse events of interest, including hypotension, syncope, electrolyte abnormality and acute kidney injury, between the two treatment targets."
    }
  ]
}