Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT02437058
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2015-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validity of Scales to Assess Severity in Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1854}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2015-05-05', 'studyFirstSubmitQcDate': '2015-05-06', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Poor evolution', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'readmission', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '27730492', 'type': 'DERIVED', 'citation': 'Garcia-Gutierrez S, Quintana JM, Anton-Ladislao A, Gallardo MS, Pulido E, Rilo I, Zubillaga E, Morillas M, Onaindia JJ, Murga N, Palenzuela R, Ruiz JG; AHFRS Group. Creation and validation of the acute heart failure risk score: AHFRS. Intern Emerg Med. 2017 Dec;12(8):1197-1206. doi: 10.1007/s11739-016-1541-4. Epub 2016 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'The scales measuring the severity of acute decompensate heart failure (ADHF) in emergency departments have not achieved an adequate discriminative ability for decision making. Objectives: 1) Identify baseline variables, and evolutionary variables that may provide a good predictive ability of the model.2) Create and validate clinical predictive rules of mortality during admission/a week after ED visit in those discharged from ED, 30 and 60 days after ED visit as well as identify predicitive factors of short-term readmission (90 days)Design: Prospective cohort study. The sociodemographics and clinical variables will be collected from emergency medical records to identify predictors. Outcome variables and evolution of variables will be collected from hospital medical records / ambulatory during admission and up to 90 days after the episode of ADHF. Baseline predictors and evolutionary variables will be identified through logistic regression models using 60% of the final sample. The models that best fit will be applied in 40% of the sample to assess the predictive validity of this scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptoms of acute decompensated heart failure who attended the emergency departments of 3 hospitals belonging to the Basque National Health Service', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* They were diagnosed as heart failure) HF is defined, clinically, as a syndrome in which patients have typical symptoms (e.g.breathlessness, ankle swelling, and fatigue) and signs (e.g. elevated jugular venous pressure, pulmonary crackles, and displaced apex beat) resulting from an abnormality of cardiac structure or function.(8) We included the following presentation of acute heart failure (AHF) at ED: acute decompensated heart failure, hypertensive acute heart failure, pulmonary oedema, cardiogenic shock, and high output failure. (9;10)\n\nExclusion Criteria:\n\n* Patients whose main diagnosis in the ER is different than acute heart failure and those not wishing to participate in the study or signing the informed consent.'}, 'identificationModule': {'nctId': 'NCT02437058', 'acronym': 'AHFRS', 'briefTitle': 'Validity of Scales to Assess Severity in Acute Heart Failure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Galdakao-Usansolo'}, 'officialTitle': 'Validition of Scales for the Assessment of Sverity in Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': '2011111045'}}, 'armsInterventionsModule': {'interventions': [{'name': 'preidictive model', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jose María Quintana, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chief of Research unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Galdakao-Usansolo', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hospital Donostia', 'class': 'OTHER'}, {'name': 'Hospital de Basurto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD', 'investigatorFullName': 'Susana García Gutiérrez', 'investigatorAffiliation': 'Hospital Galdakao-Usansolo'}}}}