{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:emperor-preserved",
  "owner": "cardio",
  "kind": "study",
  "slug": "emperor-preserved",
  "name": "EMPEROR-Preserved",
  "aliases": [
    "Empagliflozin outcome trial in heart failure with preserved ejection fraction"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A large trial in adults with heart failure and an ejection fraction above 40%. About half were given empagliflozin 10 mg once a day and half a placebo, on top of usual treatment. Over a median of about 26 months, fewer people on empagliflozin died from cardiovascular causes or were admitted to hospital for heart failure. The authors say this effect was mainly due to fewer hospital admissions for heart failure. Genital and urinary tract infections and low blood pressure were reported more often with empagliflozin.",
  "summary_technical": "Boehringer Ingelheim-sponsored (Eli Lilly and Company is a registry collaborator), randomized, double-blind, placebo-controlled phase 3 trial (NCT03057951) of 5988 patients with NYHA class II to IV heart failure and an ejection fraction of more than 40%. Primary outcome: cardiovascular death or hospitalization for heart failure, hazard ratio 0.79 (95% CI 0.69 to 0.90) over a median of 26.2 months, from the PubMed abstract. The abstract says the effect was mainly related to a lower risk of hospitalization for heart failure. The registry title and official title say preserved ejection fraction; the abstract entry criterion is an ejection fraction above 40%, so the trial includes people whom a US government patient page would call borderline (41% to 49%). The full text was not read. Funding is stated in the abstract as Boehringer Ingelheim and Eli Lilly.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT03057951",
      "normalized_value": "NCT03057951",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "heart"
      ],
      "condition-area": [
        "heart-failure"
      ]
    }
  },
  "payload": {
    "design": "Randomized, parallel-group, double-blind, placebo-controlled phase 3 trial of empagliflozin 10 mg once daily added to usual therapy in people with an ejection fraction above 40%. The abstract calls it double-blind and the registry records masking as double.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2017-03-02",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2021-04-26",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
    },
    "completion_date": {
      "date": "2021-04-26",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
    },
    "results_first_posted": {
      "date": "2022-06-06",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "AR",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "AU",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "BE",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "BR",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "CN",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "CO",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "CZ",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "DE",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "HU",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "IN",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "IT",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "JP",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "MX",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "NL",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "PL",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "RO",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "SG",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "ZA",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "KR",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "ES",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      },
      {
        "code": "GB",
        "snapshot": "cardio:ctgov-nct03057951-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 5988,
        "basis": "randomized",
        "unit": "patients",
        "snapshot": "cardio:pubmed-34449189-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:emperor-preserved-arm-empagliflozin",
        "label": "Empagliflozin",
        "intervention": "cardio:empagliflozin",
        "description": "Empagliflozin 10 mg once daily, added to usual therapy (abstract). The registry labels the arm 10 mg Empagliflozin."
      },
      {
        "id": "cardio:emperor-preserved-arm-placebo",
        "label": "Placebo",
        "intervention": null,
        "description": "Placebo, added to usual therapy (abstract and registry)."
      }
    ],
    "findings": []
  },
  "content_digest": "02a8d7eb341ec63b2eb15efcff52185691dd123f08479539141ddcee44f1f12e",
  "review": {
    "content_digest": "02a8d7eb341ec63b2eb15efcff52185691dd123f08479539141ddcee44f1f12e",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests this medicine",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:empagliflozin",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03057951-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Studies people with this condition",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:hfpef",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
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          "locator": "protocolSection.identificationModule.briefTitle"
        },
        "primary": false,
        "role": null,
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      },
      {
        "predicate": "sponsored_by",
        "label": "Lead sponsor on the registry record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:boehringer-ingelheim",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03057951-2026-10-14",
          "locator": "protocolSection.sponsorCollaboratorsModule.leadSponsor.name"
        },
        "primary": false,
        "role": "lead",
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "sponsored_by",
        "label": "Collaborator on the registry record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:eli-lilly",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03057951-2026-10-14",
          "locator": "protocolSection.sponsorCollaboratorsModule.collaborators[0].name"
        },
        "primary": false,
        "role": "collaborator",
        "valid_from": null,
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      }
    ],
    "incoming": []
  },
  "page_path": "studies/emperor-preserved/",
  "context_path": "api/v1/context/cardio--emperor-preserved.md"
}