[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100362106":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":38,"responsibleParty":76,"collaborators":18,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":18,"enrollmentInfo":88,"targetDuration":18,"studyType":91,"phases":92,"briefSummary":95,"conditions":96,"keywords":18,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Iperboreal Pharma Srl","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PolyCore PUF","EXPERIMENTAL","PolyCore peritoneal ultrafiltration (PUF) (over the top of patient's prescribed heart failure medications), for 6 months.",[13],"Drug: PolyCore (Polydextrin, L-Carnitine, D-xylitol)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Patients in the control arm (receiving no PUF therapy) will remain on their prescribed heart failure medications.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","PolyCore (Polydextrin, L-Carnitine, D-xylitol)","A single nightly exchange, with 2 liters PolyCore solution, lasting 12-14 hours. Patients should remain on their prescribed heart failure medications and the same dosing schedule for the duration of the study unless investigators determine medically necessary to change.",[9],[26],"PolyCore peritoneal dialysis solution",[28],{"name":29,"affiliation":30,"role":31},"Edoardo Gronda, MD","Policlinico Milano - on behalf of Cardio Renal and Metabolism Working Group of the ANMCO","STUDY_DIRECTOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Arduino Arduini, MD","CONTACT","+41 79 7878312","a.arduini@corequest.ch",[39,54,65],{"facility":40,"status":41,"city":42,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Ospedale Ss. Annunziata","RECRUITING","Chieti","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],14.16494,42.34827,{"lat":49,"lon":48},[52],{"name":53,"role":35,"phone":18,"phoneExt":18,"email":18},"Mario Bonomini, MD",{"facility":55,"status":41,"city":56,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"ASST FBF Sacco","Milan",{"type":46,"coordinates":58},[59,60],12.59836,42.78235,{"lat":60,"lon":59},[63],{"name":64,"role":35,"phone":18,"phoneExt":18,"email":18},"Maurizio Gallieni, MD",{"facility":66,"status":41,"city":67,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Ospedale Monaldi","Naples",{"type":46,"coordinates":69},[70,71],14.26811,40.85216,{"lat":71,"lon":70},[74],{"name":75,"role":35,"phone":18,"phoneExt":18,"email":18},"Giuseppe Pacileo, MD",{"type":77,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100362106","phase-1-peritoneal-ultrafiltration-in-cardio-renal-syndrome-100362106",false,"NCT03994874","Peritoneal Ultrafiltration in Cardio Renal Syndrome.","Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation.","PURE","Inclusion Criteria:\n\n* Age ≥18 yrs\n* Left ventricular ejection fraction ≤60%\n* NYHA Classification of III-IV despite guidelines directed medical therapy\n* Right ventricular failure due to after load mismatch, addressed by the presence of tricuspid calve regurgitation (≥ moderate) and by the disproportioned increase of the right atrial pressure (RAP) versus the capillary wedge pressure (CWP) with a ratio ≥0.65, detected with right heart catheterization performed after stable medical therapy according to international guidelines and comprehensive of loop diuretic (equivalent to furosemide oral dose till 2.0 mg\u002Fkg\u002Fday), coupled with urinary sodium excretion ≤ mEq\u002FL, confirmatory of loop diuretic resistance.\n* Cava vein enlargement (inner diameter, detected with focused echocardiography, between 1,5 and 2,5 cm, with respiratory collapse \\\u003C50% or absent due to intravascular fluid overload)\n* Decreased kidney function addressed by the measurement of glomerular filtration rate (GFR) urea clearance + creatinine clearance\u002F2 (\\>15 ml\u002Fmin\u002F1,73 m2)\n* NT pro-BNP plasma concentration \\> 1000 pg\u002Fml or BNP plasma concentration \\> 250 pg\u002Fml\n* at least one episode of pulmonary or systemic congestion requiring high-dose intravenous diuretics (or diuretic combinations) in the 6 months befor the study enrollment\n* An appropriate PUF technique candidate.\n* Signed informed consent\n\nExclusion Criteria:\n\n* Recipients of heart transplantation\n* Presence of a mechanical circulatory support device;\n* Hypertrophic obstructive cardiomyopathy;\n* Uncontrolled hypertension with systolic blood pressure ≥ 160 mmHg\n* Severe valvular stenosis;\n* Restrictive cardiomyopathy;\n* Acute coronary syndrome ≤ 6 months before;\n* Active myocarditis\n* Cardiosurgical or Endo-radiological heart procedures ≤ 6 months before\n* Cardiac resynchronization therapy (CRT) implantation or upgrading of pacemaker (PM) or implantable cardioverter defibrillator (ICD) to CRT ≤ 6 months before;\n* Patient with end-stage renal disease, GFR urea clearance + creatinine clearance\u002F2 (\\\u003C15 ml\u002Fmin\u002F1,73 m2 GFR)\n* Any major organ transplant (liver, lung, kidney)\n* Lung embolism ≤ 6 months before;\n* Fibrotic lung disease;\n* Liver Cirrhosis;\n* Absolute contraindication to peritoneal catheter implantation;\n* Logistical and or organizational contra-indication to treatment\n* Active malignancy;\n* Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical trial and for three months later\n* Female patients of childbearing age who do not use adequate contracteption.\n* Unwilling and unable to give informed consent;\n* Enrolment in another clinical trial involving medical or device based interventions.\n* Hypersensibility to IMP components.\n* Evidence of any condition that, according to the investigators' judgment, could expose the subject to undue risk and\u002For prevent the subject from participating in the study procedures and\u002For potentially afftecting the study quality data.","ALL","18 Years",{"count":89,"type":90},84,"ESTIMATED","INTERVENTIONAL",[93,94],"PHASE1","PHASE2","Randomized, controlled, unblinded, adaptive design clinical trial to evaluate the safety and efficacy of PolyCore (Polydextrin, L-Carnitine, D-xylitol) peritoneal ultrafiltration (PUF) in patients with heart failure and reduced ejection fraction (HFrEF).",[97],"Congestive Heart Failure","2025-05-13",{"date":100,"type":101},"2025-05-16","ACTUAL",{"date":103,"type":101},"2025-04-16",{"date":105,"type":90},"2027-06",{"name":5,"class":6},3]