Peritoneal Ultrafiltration in Cardio Renal Syndrome.
ConditionCongestive Heart Failure
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIperboreal Pharma Srl
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
Recipients of heart transplantation
Presence of a mechanical circulatory support device;
Hypertrophic obstructive cardiomyopathy;
Uncontrolled hypertension with systolic blood pressure ≥ 160 mmHg
Trial design
Treatments tested in this trial
- PolyCore (Polydextrin, L-Carnitine, D-xylitol)
Treatment groups
84 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov