Phase
Condition
Congestive Heart Failure
Heart Failure
Chest Pain
Treatment
Medical therapy including loop diuretic (furosemide) daily dose up to 2.5 mg/kg/day,
PolyCore (Polydextrin, L-Carnitine, D-xylitol)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 yrs
Left ventricular ejection fraction ≤60%
NYHA Classification of III-IV despite guidelines directed medical therapy
Right ventricular failure due to after load mismatch, addressed by the presence oftricuspid calve regurgitation (≥ moderate) and by the disproportioned increase ofthe right atrial pressure (RAP) versus the capillary wedge pressure (CWP) with aratio ≥0.65, detected with right heart catheterization performed after stablemedical therapy according to international guidelines and comprehensive of loopdiuretic (equivalent to furosemide oral dose till 2.0 mg/kg/day), coupled withurinary sodium excretion ≤ mEq/L, confirmatory of loop diuretic resistance.
Cava vein enlargement (inner diameter, detected with focused echocardiography,between 1,5 and 2,5 cm, with respiratory collapse <50% or absent due tointravascular fluid overload)
Decreased kidney function addressed by the measurement of glomerular filtration rate (GFR) urea clearance + creatinine clearance/2 (>15 ml/min/1,73 m2)
NT pro-BNP plasma concentration > 1000 pg/ml or BNP plasma concentration > 250 pg/ml
at least one episode of pulmonary or systemic congestion requiring high-doseintravenous diuretics (or diuretic combinations) in the 6 months befor the studyenrollment
An appropriate PUF technique candidate.
Signed informed consent
Exclusion
Exclusion Criteria:
Recipients of heart transplantation
Presence of a mechanical circulatory support device;
Hypertrophic obstructive cardiomyopathy;
Uncontrolled hypertension with systolic blood pressure ≥ 160 mmHg
Severe valvular stenosis;
Restrictive cardiomyopathy;
Acute coronary syndrome ≤ 6 months before;
Active myocarditis
Cardiosurgical or Endo-radiological heart procedures ≤ 6 months before
Cardiac resynchronization therapy (CRT) implantation or upgrading of pacemaker (PM)or implantable cardioverter defibrillator (ICD) to CRT ≤ 6 months before;
Patient with end-stage renal disease, GFR urea clearance + creatinine clearance/2 (<15 ml/min/1,73 m2 GFR)
Any major organ transplant (liver, lung, kidney)
Lung embolism ≤ 6 months before;
Fibrotic lung disease;
Liver Cirrhosis;
Absolute contraindication to peritoneal catheter implantation;
Logistical and or organizational contra-indication to treatment
Active malignancy;
Female patients who are pregnant or breast-feeding or who wish to become pregnantduring the period of the clinical trial and for three months later
Female patients of childbearing age who do not use adequate contracteption.
Unwilling and unable to give informed consent;
Enrolment in another clinical trial involving medical or device based interventions.
Hypersensibility to IMP components.
Evidence of any condition that, according to the investigators' judgment, couldexpose the subject to undue risk and/or prevent the subject from participating inthe study procedures and/or potentially afftecting the study quality data.
Study Design
Study Description
Connect with a study center
Ospedale Ss. Annunziata
Chieti,
ItalyActive - Recruiting
ASST FBF Sacco
Milano,
ItalyActive - Recruiting
Ospedale Monaldi
Napoli,
ItalyActive - Recruiting
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