[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629988":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":24,"responsibleParty":41,"collaborators":24,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":24,"enrollmentInfo":55,"targetDuration":24,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":70,"whyStopped":24,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":24},{"fullName":5,"class":6},"University of Bari Aldo Moro","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: Standard Respiratory Management",{"label":15,"type":10,"description":16,"interventionNames":17},"Combined Cardio-Pulmonary Assessment","Participants receive standard COPD outpatient evaluation plus structured cardiovascular assessment including ECG and transthoracic echocardiography, with integrated cardio-pulmonary management.",[18],"Other: Structured combined cardio-pulmonary clinical management strategy",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"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.",[15],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"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.",[9],[30],"Standard of Care (SOC)",[32],{"name":33,"affiliation":34,"role":35},"Giovanna Elisiana Carpagnano, MD, PhD","Institute of Respiratory Disease, Department of Translational Biomedicine and neuroscience, University \"Aldo Moro\", Bari, Italy","STUDY_DIRECTOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":24,"email":40},"CONTACT","+39 080559","elisiana.carpagnano@uniba.it",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Prof. Giovanna Elisiana Carpagnano","MD, PhD","100629988","impact-of-combined-cardio-pulmonary-assessment-on-copd-clinical-management-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":56,"type":57},350,"ESTIMATED","INTERVENTIONAL",[60],"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",[63,64],"COPD (Chronic Obstructive Pulmonary Disease)","Cardiovascular Disease",[66,67,68,69],"COPD","Chronic Obstructive Pulmonary Disease","Cardiovascular","cardio-pulmonary","NOT_YET_RECRUITING","2026-03-15",{"date":73,"type":74},"2026-03-19","ACTUAL",{"date":76,"type":57},"2026-09",{"date":78,"type":57},"2029-11",{"name":5,"class":6}]