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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
PolyCore (Polydextrin, L-Carnitine, D-xylitol)
DrugA 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: PolyCore PUFExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Composite end-point of mortality and worsening patient's condition
* patient's mortality - or * the need of increasing of ≥50% the initial daily dose of loop diuretic - or * the hospitalization for infusional therapy with loop diuretic based on the lack of adequate response to maximal dose of oral furosemide (\>2.5 mg/kg/day) - or * requiring other methods of treatment \[i.e. PUF or hemodialysis\], based on persistence of high venous congestion (detected with central venous pressure measurement: \>8 mm Hg or dilated inferior cava vein, without respiratory change, measured with focused abdominal echography, and coupled with body weight increase of 1 kg or more in the last 24 hrs.
Time frame
Up to 7 months from randomizationSecondary outcomes
1
6 min Walking distance
Change from the baseline
Time frame
At 3, 6 and 7 months from randomization2
Quality of life tested with Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change from the baseline
Time frame
At 3, 6 and 7 months from randomization3
Number of patients with decrease of NT pro-BNP (N-terminal pro brain natriuretic peptide)
The number of patients with a decrease in NT pro-BNP level of ≥25% from baseline
Time frame
At 3, 6 and 7 months from randomization4
Worsening of renal function
Estimated Glomerular Filtration Rate (eGFR) ≤20 ml/min
Time frame
Up to 7 months from randomizationSponsors and contacts
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Source ClinicalTrials.gov