Peritoneal Ultrafiltration in Cardio Renal Syndrome.

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CoreQuest, Switzerland
• Treatments: Dialysis Solutions; Diuretics; Furosemide; Sodium Potassium Chloride Symporter Inhibitors

Criteria

Inclusion Criteria:

• Age ≥18 yrs

• ≥ 3 months follow-up in the clinic

• Left ventricular ejection fraction ≤40%

• NYHA Classification of III-IV despite guidelines directed medical therapy

• Hospitalized for heart failure

• Right ventricular failure due to after load mismatch, addressed by the presence of tricuspid valve regurgitation 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 (furosemide) dose till to 2.5mg/kg/day, coupled with urinary sodium excretion ≤ 70 mEq/L/day, confirmatory of loop diuretic resistance (4).

• 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.

• The presence of at least one hospitalization for HF lasting 3 days or more in the 6 months before the study enrolment

• An appropriate PUF technique candidate.

• Signed informed consent

Exclusion Criteria:

• Recipients of heart transplantation

• Presence of a mechanical circulatory support device;

• Isolated Right Heart Failure;

• Isolated Left Ventricular diastolic dysfunction;

• Hypertrophic obstructive cardiomyopathy;

• 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;

• Pregnancy;

• Unwilling and unable to give informed consent;

• Enrolment in another clinical trial involving medical or device based interventions.