Nctid:
NCT06616038
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000006333", "term"=>"Heart Failure"}, {"id"=>"D000001281", "term"=>"Atrial Fibrillation"}], "ancestors"=>[{"id"=>"D000006331", "term"=>"Heart Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000001145", "term"=>"Arrhythmias, Cardiac"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M4586", "name"=>"Atrial Fibrillation", "asFound"=>"Atrial Fibrillation", "relevance"=>"HIGH"}, {"id"=>"M9421", "name"=>"Heart Failure", "asFound"=>"Heart Failure", "relevance"=>"HIGH"}, {"id"=>"M27583", "name"=>"Systolic Murmurs", "relevance"=>"LOW"}, {"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}, {"id"=>"M4453", "name"=>"Arrhythmias, Cardiac", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>114}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-30", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-10-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-18", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-08-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Evaluation of FAR", "timeFrame"=>"At Hospital admission", "description"=>"Evaluate FAR (=Fibrin/Albumin) in heart failure HFrEF and HFpEF with or without atrial fibrillation."}], "secondaryOutcomes"=>[{"measure"=>"FAR (=Fibrinogen/Albumin) and functional ultrasound", "timeFrame"=>"At Hospital admission and at hospital discharge (assessed up to 1 months)", "description"=>"Correlate FAR to functional ultrasound indices of atrium and ventricle and to the presence of atrial fibrillation."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Hart failure", "Ejection fraction", "atrial fibrillation"], "conditions"=>["Atrial Fibrillation (AF)", "Hart Failure"]}, "descriptionModule"=>{"briefSummary"=>"Systemic inflammation is closely associated with the development and progression of heart failure (HF). The study assessed the fibrin/albumin (FAR) ratio, a very important biomarker, as a prognostic indicator of HE. Study population is composed by patients who were addicted with heart failure diagnosed for the first time or already under treatment (NYHA class II-IV) and reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).", "detailedDescription"=>"Prospective, observational, single-center study, which involves the enrollment of patients affected by heart failure of first diagnosis or already in therapy, who will be subjected to an analysis of the Albumin/fibrinogen ratio. Subjects will not be subjected to specific visits or services for the study: clinical and anamnestic data will be collected during routine visits."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Will be enrolled 114 patients admitted to the Hospital for heart failure of first diagnosis or already undergoing therapy. In particular, 57 patients with heart failure and 57 patients with heart failure and fibrillation will be included.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients ≥ 18 years\n* Patients with newly diagnosed or already treated heart failure (NYHA class II-IV) with HFrEF and HFpEF with and without atrial fibrillation.\n* Patients who sign the consent to participate in the study\n\nExclusion Criteria:\n\n* Patients with infectious/autoimmune diseases, neoplasms, liver failure, renal failure (Cl creatinine \\< 30 mL/L), structural cardiomyopathies and pericarditis.\n* Pregnant/breastfeeding women (verified by self-declaration)"}, "identificationModule"=>{"nctId"=>"NCT06616038", "acronym"=>"BIOHF", "briefTitle"=>"Heart Failure Biomarkers", "organization"=>{"class"=>"OTHER", "fullName"=>"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, "officialTitle"=>"Biomarker Assessment in Heart Failure with Reduced Systolic Function (HFrEF) and Preserved Systolic Function (HFpEF)", "orgStudyIdInfo"=>{"id"=>"BIOHF"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"heart failure patients (HFrEF and HFpEF) without atrial fibrillation", "description"=>"Will be enrolled 57 patients with heart failure patients (HFrEF and HFpEF) without atrial fibrillation", "interventionNames"=>["Other: Data collection"]}, {"label"=>"heart failure patients (HFrEF and HFpEF) with atrial fibrillation", "description"=>"Will be enrolled 57 patients with heart failure patients (HFrEF and HFpEF) with atrial fibrillation", "interventionNames"=>["Other: Data collection"]}], "interventions"=>[{"name"=>"Data collection", "type"=>"OTHER", "description"=>"Given the observational nature of the study, the intervention is a simple data collection", "armGroupLabels"=>["heart failure patients (HFrEF and HFpEF) with atrial fibrillation", "heart failure patients (HFrEF and HFpEF) without atrial fibrillation"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Milano", "country"=>"Italy", "contacts"=>[{"name"=>"Direzione Scientifica Direzione Scientifica", "role"=>"CONTACT", "email"=>"direzionescientifica.ogsa@grupposandonato.it", "phone"=>"+390283502227"}, {"name"=>"Fabrizio Dr. Colombo", "role"=>"CONTACT"}], "facility"=>"IRCCS Galeazzi-Sant&#39;Ambrogio", "geoPoint"=>{"lat"=>45.46427, "lon"=>9.18951}}, {"zip"=>"20157", "city"=>"Milan", "country"=>"Italy", "contacts"=>[{"name"=>"Direzione Scientifica Direzione Scientifica", "role"=>"CONTACT", "email"=>"direzionescientifica.ogsa@grupposandonato.it", "phone"=>"+390283502227"}], "facility"=>"IRCCS Ospedale Galeazzi-Sant'Ambrogio", "geoPoint"=>{"lat"=>45.46427, "lon"=>9.18951}}], "centralContacts"=>[{"name"=>"Fabrizio Dr. Colombo", "role"=>"CONTACT", "email"=>"direzionescientifica.ogsa@grupposandonato.it", "phone"=>"0283502227", "phoneExt"=>"0039"}, {"name"=>"Direzione Scientifica Direzione Scientifica", "role"=>"CONTACT", "email"=>"direzionescientifica.ogsa@grupposandonato.it", "phone"=>"0283502227", "phoneExt"=>"0039"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
