[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565281":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":52,"collaborators":12,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":12,"enrollmentInfo":64,"targetDuration":12,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":77,"whyStopped":12,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Fundación para la Investigación del Hospital Clínico de Valencia","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual care","NO_INTERVENTION","Patients allocated to this arm will receive the usual care plus explicit recommendations for home-based aerobic and strength training.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Supervised aerobic plus strenght training","ACTIVE_COMPARATOR","Patients allocated to this arm will receive the usual care plus supervised aerobic and strength training.",[18],"Behavioral: Supervised aerobic plus strength training",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Supervised aerobic plus strength training","Supervised moderate to high-intensity interval aerobic training plus moderate to high-intensity strength training.",[14],[26],{"name":27,"affiliation":28,"role":29},"Gonzalo Núñez Marín, MD","Instituto de investigación sanitaria INCLIVA","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Patricia Fernández, PhD","CONTACT","961973536","+34","patricia.fernandez@incliva.es",[38],{"facility":28,"status":12,"city":39,"state":12,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Valencia","46010","Spain","ES",{"type":44,"coordinates":45},"Point",[46,47],-0.37966,39.47391,{"lat":47,"lon":46},[50],{"name":32,"role":33,"phone":51,"phoneExt":12,"email":36},"+34961973536",{"type":53,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100565281","effects-of-a-supervised-training-program-on-functional-capacity-in-patients-with-hf-and-cardiorenal-syndrome-100565281",false,"NCT06640140","Effects of a Supervised Training Program on Functional Capacity in Patients With HF and Cardiorenal Syndrome","Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Cardiorenal Syndrome","Train-CR","Inclusion Criteria:\n\n* Patients diagnosed with heart failure according to 2021 ESC guidelines for Heart Failure.\n* Evidence of cardiorenal syndrome, defined as coexistent very high risk chronic kidney disease (CKD) (estimated glomerular filtration rate \\[eGFR\\] \\<30 ml\u002Fmin\u002F1.73m2 or eGFR 30 to 44 ml\u002Fmin\u002F1.73m2 and Urine Albumin-Creatinine Ratio \\[uACR\\] \\>30 mg\u002Fg) or rapidly progressive CKD (loss of \\>5 ml\u002Fmin\u002F1.73m2 in one year).\n* Stable symptomatic heart failure patients (New York Heart Association functional class II-III\u002FIV) during the last month.\n* Age ≥ 18 years old.\n* Willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Inability to perform a valid baseline cardiopulmonary exercise test.\n* Significant primary severe valve disease that is considered the main symptom driver.\n* Effort angina or signs of ischemia during CPET.\n* Primary cardiomyopathies.\n* Cardiac transplantation.\n* Any other comorbidity with a life expectancy of less than one year.","ALL","18 Years",{"count":65,"type":66},26,"ESTIMATED","INTERVENTIONAL",[69],"NA","This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing combined with echocardiography (echo-CPET) at 12 weeks. Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled. A sample size estimation \\[alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +2,4 mL\u002Fkg\u002Fmin (SD±2)\\] of 26 patients (13 per arm) would be necessary to test our hypothesis.",[72,73],"Heart Failure","Cardiorenal Syndrome",[75,73,76],"Heart failure","Functional Capacity","NOT_YET_RECRUITING","2024-10-10",{"date":80,"type":81},"2024-10-15","ACTUAL",{"date":83,"type":66},"2024-10-08",{"date":85,"type":66},"2025-12",{"name":5,"class":6},1]