{ "data": { "asOf": "2026-10-30T22:25:00.905Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07449377", "title": "Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department", "scientificTitle": "Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department", "status": "recruiting", "studyType": "interventional", "phase": [], "conditions": [ "Acute Heart Failure (AHF)" ], "interventions": [ { "name": "FibroScan®", "type": "DEVICE", "description": "The patient will then receive standard medical care, including blood tests and imaging as needed. Once inclusion is confirmed, the patient will undergo a liver stiffness measurement with the Fibroscan® device(Class IIa medical device, CE marked for off-label us) , and the results, including a computed score, will be documented on a separate sheet. The measurement will be performed during the emergency department stay without delaying the initiation of any necessary treatment. The remainder of the patient's management will proceed as per standard care protocols.\n\nThe assessment of liver stiffness will be performed before results of blood test and imaging studies.\n\nPatients will be followed up until hospital discharge or 28-day days post-admission, whichever comes first." } ], "sponsor": { "name": "Assistance Publique - Hôpitaux de Paris", "type": "OTHER" }, "locations": [ { "city": "Paris", "country": "France", "facility": "Name: Emergency Department Hospital Pitié-Salpêtrière, APHP" } ], "outcomes": { "other": [ "Association between hospital mortality, hospital length of stay, and adverse events with the Liver Stiffness Measurement (LSM) will also be collected.", "Adverse events with the Liver Stiffness Measurement (LSM)" ], "primary": [ "The Area under the Receiving Operator Characteristic curve (AUC ROC) of Liver Stiffness Measurement (LSM) value to diagnose AHF. Other diagnostic performances will also be assessed at the threshold determined by Youden's method." ], "secondary": [ "Association between the Liver Stiffness Measurement (LSM) and the score of congestion according to a validated clinical congestion score that ranges from 0 to 9." ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n1. Patients ≥18 years\n2. ED patients presenting with acute dyspnea and absence of any other obvious cause of dyspnea (for example pneumothorax, acute pneumonia, acute coronary syndrome, Covid) …\n3. Social security affiliation (except AME)\n4. Informed consent signed\n\nExclusion Criteria:\n\n1. Known chronic liver disease, defined by a Prothrombic time of \\< 50%, or any former diagnosis of liver fibrosis.\n2. No skin wounds in the abdominal area on which the Fibroscan® will be used\n3. History of liver transplantation\n4. eGFR \\<30 mL/min\n5. Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom\n6. Pregnancy and breastfeeding\n7. Participation in another interventional trial", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 100 }, "startDate": "2026-04-02", "completionDate": "2027-05-01", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2026-03-04T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07449377" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07449377", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07449377", "sourceUrl": "https://clinicaltrials.gov/study/NCT07449377", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-28T04:32:12.777Z", "payloadSha256": "8b3cd385fff82803b63593c36ee748b9eba472f3826c037cd0b9689219da847d", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07449377", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07449377", "verifyAt": "https://clinicaltrials.gov/study/NCT07449377", "retrievedAt": "2026-10-28T04:32:12.777Z", "payloadSha256": "8b3cd385fff82803b63593c36ee748b9eba472f3826c037cd0b9689219da847d", "text": "ClinicalTrials.gov, record NCT07449377 (https://clinicaltrials.gov/study/NCT07449377), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07449377, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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