Trial | NCT03994874  Report issue

Title

Peritoneal Ultrafiltration in Cardio Renal Syndrome.
Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation.

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Not yet recruiting

  • Study Participants

    84
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).
The study will include adults HFrEF patients, that despite guidelines directed medical therapy still retain a congestive heart failure (HF) picture. During the study, 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. Patients will be assigned randomly to receive either PolyCore PUF (over the top of their prescribed heart failure medications), for 6 months, or to the control arm receiving stable medical therapy according to international guidelines and comprehensive of loop diuretic (furosemide) dose till to 2.5mg/kg/day, without PUF therapy. The PUF ultrafiltration will be performed with a single nightly exchange, with 2 liters PolyCore solution, lasting 12-14 hours, for 6 months. An independent data safety monitoring board (DSMB) will be convened for this study and will review the results of the trial at regular intervals to protect patients participating in the study. An adaptive interim analysis will be performed when in each group 20 patients have completed 6 months in the study, for analysis of the primary outcome. The purpose of the adaptive interim analysis is to calculate the final study sample size.The DSMB will closely examine the interim primary efficacy results, respecting the confidentiality and integrity of data, to investigate the final sample sizes necessary to complete the study.
Study Started
Nov 30
2023
Anticipated
Primary Completion
Nov 30
2025
Anticipated
Study Completion
Mar 31
2026
Anticipated
Last Update
Nov 18
2023

Drug PolyCore (Polydextrin, L-Carnitine, D-xylitol) [polydextrin, levocarnitine (carnitor), 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.

  • Other names: PolyCore peritoneal dialysis solution

PolyCore PUF Experimental

PolyCore peritoneal ultrafiltration (PUF) (over the top of patient's prescribed heart failure medications), for 6 months.

Control No Intervention

Patients in the control arm (receiving no PUF therapy) will remain on their prescribed heart failure medications.

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.
No Results Posted