Peritoneal Ultrafiltration in Cardio Renal Syndrome.

Launched by IPERBOREAL PHARMA SRL · Jun 20, 2019

Keywords

ClinConnect Summary

This clinical trial, called "Peritoneal Ultrafiltration in Cardio Renal Syndrome," is looking to see if a new treatment called PolyCore (which includes ingredients like Polydextrin and L-Carnitine) can safely help patients with heart failure and reduced heart function. Heart failure means the heart isn’t pumping blood as well as it should. The study is specifically for adults aged 18 and older who have certain heart and kidney issues, including a weakened heart function and difficulties with fluid overload that standard treatments haven't resolved.

If you or a loved one is considering participating in this trial, you should know that participants will be treated with this new method and monitored closely for safety and effectiveness. However, not everyone will qualify; for example, individuals with severe heart or lung conditions, recent major surgeries, or certain other health issues may not be eligible. The trial is not yet recruiting participants, but it's important for potential candidates to understand the criteria and the commitment involved, including providing informed consent and potentially undergoing additional medical evaluations.

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Eligibility criteria

• 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 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/kg/day), coupled with urinary 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 to intravascular 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-dose intravenous diuretics (or diuretic combinations) in the 6 months befor the study enrollment
• • An appropriate PUF technique candidate.
• • Signed informed consent
• 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 pregnant during 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, could expose the subject to undue risk and/or prevent the subject from participating in the study procedures and/or potentially afftecting the study quality data.