[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629988":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":40,"armGroups":47,"interventions":59,"overallOfficials":70,"centralContacts":75,"locations":40,"responsibleParty":80,"collaborators":40,"id":84,"slug":40,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":40,"enrollmentInfo":93,"targetDuration":40,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":108,"whyStopped":40,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":40},{"fullName":5,"class":6},"University of Bari Aldo Moro","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":40},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Change in Left Ventricular Ejection Fraction (EF)","Mean change in left ventricular ejection fraction measured by transthoracic echocardiography from baseline to 12 months.","Baseline to 12 months",{"measure":14,"description":15,"timeFrame":12},"Change in 6-Minute Walk Distance (6MWD)","Mean change in 6-minute walk distance measured according to ERS\u002FATS standards from baseline to 12 months.",{"measure":17,"description":18,"timeFrame":12},"Change in NT-proBNP Levels","Mean change in plasma NT-proBNP levels from baseline to 12 months.",{"measure":20,"description":21,"timeFrame":12},"Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score","Mean change in KCCQ-12 overall summary score from baseline to 12 months.",[23,27,31,34,37],{"measure":24,"description":25,"timeFrame":26},"Number of new cardiovascular diseases diagnoses","Number of new cardiovascular disease diagnoses (heart failure, atrial fibrillation, coronary artery disease, systemic arterial hypertension) identified during follow-up.","Up to 12 months",{"measure":28,"description":29,"timeFrame":30},"Annual COPD Exacerbation Rate","Rate of COPD exacerbations during follow-up (events per patient-year), defined according to standard clinical criteria and recorded from clinical visits\u002Fmedical records.","12 months",{"measure":32,"description":33,"timeFrame":12},"Change in Forced Expiratory Volume in 1 Second (FEV1)","Mean change in post-bronchodilator FEV1 from baseline to 12 months measured by spirometry.",{"measure":35,"description":36,"timeFrame":26},"Emergency department visits or hospitalizations for cardiovascular worsening","Number of emergency department visits and\u002For hospitalizations due to cardiovascular disease worsening during follow-up.",{"measure":38,"description":39,"timeFrame":12},"Proportion of participants achieving KCCQ-12 MCID improvement","Number (proportion) of participants with KCCQ-12 improvement above the minimal clinically important difference (MCID): ≥7 points for HFpEF and ≥9 points for HFmrEF.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":46,"maskingDescription":40,"whoMasked":40},"NONE",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Standard Respiratory Assessment (SOC)","ACTIVE_COMPARATOR","Participants receive standard COPD outpatient evaluation including clinical assessment, lung function testing, 6MWT, blood tests, and guideline-based management without structured cardiovascular assessment.",[53],"Other: Standard Respiratory Management",{"label":55,"type":50,"description":56,"interventionNames":57},"Combined Cardio-Pulmonary Assessment","Participants receive standard COPD outpatient evaluation plus structured cardiovascular assessment including ECG and transthoracic echocardiography, with integrated cardio-pulmonary management.",[58],"Other: Structured combined cardio-pulmonary clinical management strategy",[60,64],{"type":6,"name":61,"description":62,"armGroupLabels":63,"otherNames":40},"Structured combined cardio-pulmonary clinical management strategy","This intervention consists of a structured combined cardio-pulmonary outpatient evaluation in patients with COPD and either high cardiovascular risk or established cardiovascular disease. In addition to standard respiratory assessment (clinical history, lung function testing, 6-minute walk test, laboratory tests and guideline-based management), participants undergo a structured cardiovascular evaluation including ECG and transthoracic echocardiography. Treatment optimization is performed according to current respiratory and cardiovascular guidelines based on integrated multidisciplinary assessment. Follow-up is conducted at 12 months using the same integrated approach.",[55],{"type":6,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"Standard Respiratory Management","Participants receive standard COPD outpatient evaluation including clinical history, symptom assessment (CAT, mMRC), lung function testing, 6-minute walk test, laboratory testing and guideline-based respiratory management. No structured cardiovascular assessment (ECG or echocardiography) is systematically performed as part of the study intervention. Cardiovascular referral may occur only according to usual clinical practice.",[49],[69],"Standard of Care (SOC)",[71],{"name":72,"affiliation":73,"role":74},"Giovanna Elisiana Carpagnano, MD, PhD","Institute of Respiratory Disease, Department of Translational Biomedicine and neuroscience, University \"Aldo Moro\", Bari, Italy","STUDY_DIRECTOR",[76],{"name":72,"role":77,"phone":78,"phoneExt":40,"email":79},"CONTACT","+39 080559","elisiana.carpagnano@uniba.it",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Prof. Giovanna Elisiana Carpagnano","MD, PhD","100629988",false,"NCT07481825","Impact of Combined Cardio-pulmonary Assessment on COPD Clinical Management.","Impact of Combined cARdio-pUlmonary aSsessment on COPD Clinical Management: the ICARUS Study","ICARUS","Inclusion Criteria:\n\nPatients enrolled in the study should be diagnosed as COPD according to international recommendations (1) with the following features:\n\n* Post-bronchodilator FEV1 ≥ 50% or FEV1 z ≥ -2.5\n* Age \\> 40 years\n\nAdditionally, enrolled patients must fulfill at least one of the following cardiovascular criteria:\n\n* Very high cardiovascular risk\n\n  * according to SCORE2 (12)for patient \\\u003C 70 years old and defined as follows:\n\n    * Patients \\\u003C 50 years old \\> 7.5%\n    * Patients 50-69 years old \\> 10%\n  * according to SCORE OP 2 (13) calculator for patients \\> 70 years old and defined as \\> 15%\n* History of ischemic heart disease\n* Chronic or transient atrial fibrillation\n* Chronic heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (EF \\> 40%) (14)\n\nExclusion Criteria:\n\n* Post-bronchodilator FEV1 \\\u003C 50% or FEV1 z \\\u003C -2.5\n* LTOLT\n* Active neoplasm\n* Patient unable to perform lung function\n* Pregnancy","ALL","41 Years",{"count":94,"type":95},350,"ESTIMATED","INTERVENTIONAL",[98],"NA","The goal of this randomized clinical trial is to learn whether a combined cardio-pulmonary assessment improves cardiac function, exercise capacity, cardiac biomarkers and health-related quality of life in adults with mild-to-moderate chronic obstructive pulmonary disease (COPD) who are at high cardiovascular risk or have established cardiovascular disease.\n\nThe main questions it aims to answer are:\n\n* Does the combined cardio-pulmonary assessment improve mean left ventricular ejection fraction (EF) over 12 months compared with standard respiratory care?\n* Does the combined cardio-pulmonary assessment improve mean 6-minute walk distance (6MWD) over 12 months compared with standard respiratory care?\n* Does the combined cardio-pulmonary assessment reduce mean NT-proBNP over 12 months compared with standard respiratory care?\n* Does the combined cardio-pulmonary assessment improve mean Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score over 12 months compared with standard respiratory care?\n\nResearchers will compare a combined cardio-pulmonary assessment to standard respiratory care to see whether the integrated approach leads to greater improvements in EF, 6MWD, NT-proBNP, and KCCQ-12.\n\nParticipants will:\n\n* Be randomly assigned to receive either a combined cardio-pulmonary assessment or standard respiratory care\n* Complete a baseline visit that includes clinical assessment, respiratory function testing, blood tests (including NT-proBNP), a 6-minute walk test, and the KCCQ-12 questionnaire\n* Undergo cardiovascular evaluation (electrocardiogram and transthoracic echocardiography) if assigned to the combined assessment group\n* Attend follow-up evaluation at 12 months, repeating the same assessments according to their assigned group",[101,102],"COPD (Chronic Obstructive Pulmonary Disease)","Cardiovascular Disease",[104,105,106,107],"COPD","Chronic Obstructive Pulmonary Disease","Cardiovascular","cardio-pulmonary","NOT_YET_RECRUITING","2026-03-15",{"date":111,"type":112},"2026-03-19","ACTUAL",{"date":114,"type":95},"2026-09",{"date":116,"type":95},"2029-11",{"name":5,"class":6}]