Nctid:
NCT06228807
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D006333", "term"=>"Heart Failure"}], "ancestors"=>[{"id"=>"D006331", "term"=>"Heart Diseases"}, {"id"=>"D002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M9421", "name"=>"Heart Failure", "asFound"=>"Heart Failure", "relevance"=>"HIGH"}, {"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>584}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2015-03-09", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-11", "completionDateStruct"=>{"date"=>"2023-09-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-11-28", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-12-02", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-09-30", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Composite Events", "timeFrame"=>"From the time of hospital discharge until the event of specific outcome, death, or loss to follow up, maximum 10 years.", "description"=>"The composite events include a composite of all-cause mortality (death due to any cause), cardiovascular mortality (death due to cardiac cause), and heart failure rehospitalization."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["risk predictors", "mortality"], "conditions"=>["Heart Failure With Preserved Ejection Fraction"]}, "descriptionModule"=>{"briefSummary"=>"Heart failure with preserved ejection fraction (HFpEF) is a prevalent form of heart failure characterized by impaired left ventricle pressures and diastolic dysfunction. Despite its increasing prevalence, effective treatment options for HFpEF remain limited, probably due to its heterogenous underlying pathological etiology involving chronic systemic inflammation and metabolic dysregulation. Identifying new predictors of poor prognosis is crucial for risk stratification and tailored management.", "detailedDescription"=>"The prognosis for HFpEF is concerning, marked by significant mortality and frequent hospital readmissions. The exact mechanisms underlying HFpEF remain unresolved. The clinical syndrome arises from intricate interactions among various risk factors, leading to organ dysfunction and clinical symptoms. Common co-morbidities, including atrial fibrillation, diabetes, chronic kidney disease, and obesity, may influence HFpEF pathophysiology. Recent discussions suggest an inflammatory-metabolic phenotype in HFpEF, characterized by heightened inflammatory biomarkers, insulin resistance, hyperglycemia, hyperlipidemia, microvascular endothelial and vascular dysfunction, atherosclerosis, consequently leading to significant myocardial damage. However, there is still a lack of clinical risk predictors associated with metabolic phenotype within HFpEF.\n\nThe aim of this study is to investigate the impact of parameters reflecting the metabolic phenotype, coronary microvascular dysfunction in HFpEF and establish their correlation with clinical outcomes. The objective is to identify novel predictors for adverse prognosis in HFpEF, potentially serving as targets for drug therapy. This research aims to pave the way for targeted drug interventions in cardiometabolic diseases, offering new avenues for therapeutic approaches."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with Heart failure with preserved ejection fraction(HFpEF)", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients diagnosed with HFpEF; Diagnostic criteria for HFpEF\n\n * Presence of heart failure signs/symptoms symptoms\n * Preserved left ventricular ejection fraction (EF) ≥50%\n * BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;\n * At least one additional criteria: presence of cardiac functional and structural abnormalities or diastolic dysfunction.\n\nExclusion Criteria:\n\n* LVEF lower than 50%\n* Patients with serious hepatic and renal failure,\n* Non-cardiac causes of dyspnea, such as, asthma\n* Primary pulmonary hypertension.\n* Severe valvular heart disease.\n* Pericardial disease.\n* Recent history of myocardial infarction.\n* Coronary artery disease (stenosis\\>50).\n* Reduced contrast opacification (for caIMR assessment)."}, "identificationModule"=>{"nctId"=>"NCT06228807", "briefTitle"=>"Clinical Characteristics and Predictors of Adverse Outcomes in HFpEF", "organization"=>{"class"=>"OTHER", "fullName"=>"Shanghai 10th People's Hospital"}, "officialTitle"=>"Exploring Clinical Characteristics and Predictors of Adverse Outcomes in Patients Diagnosed With Heart Failure With Preserve Ejection Fraction (HFpEF)", "orgStudyIdInfo"=>{"id"=>"HFpEF-CCPO"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"HFpEF patients with metabolic abnormalities", "interventionNames"=>["Combination Product: The study involved a comparison of clinical characteristics, medical history, laboratory biomarkers, echocardiographic measurements, angiographic findings, and clinical outcomes between two groups."]}, {"label"=>"HFpEF patients without metabolic abnormalities", "interventionNames"=>["Combination Product: The study involved a comparison of clinical characteristics, medical history, laboratory biomarkers, echocardiographic measurements, angiographic findings, and clinical outcomes between two groups."]}], "interventions"=>[{"name"=>"The study involved a comparison of clinical characteristics, medical history, laboratory biomarkers, echocardiographic measurements, angiographic findings, and clinical outcomes between two groups.", "type"=>"COMBINATION_PRODUCT", "description"=>"Differences in clinical characteristics, history, laboratory biomarkers, echocardiographic measurements, angiographic findings, coronary microvascular function using caIMR and clinical outcomes were assessed between the two groups to identify potential risk factors. Subsequently, the incidence of clinical outcomes and mortality was compared. Univariate logistic regression and multivariate logistic regression analyses, adjusted for significant risk factors, were conducted to identify independent predictive factors. Finally, a Receiver Operating Characteristic (ROC) curve was generated, and the area under the curve was evaluated to assess the predictive accuracy of the regression model.", "armGroupLabels"=>["HFpEF patients with metabolic abnormalities", "HFpEF patients without metabolic abnormalities"]}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ya-Wei Xu", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Chief Physician", "investigatorFullName"=>"Ya-Wei Xu", "investigatorAffiliation"=>"Shanghai 10th People's Hospital"}}}}
