Peritoneal Ultrafiltration in Cardio Renal Syndrome.

NCT03994874 | Recruiting Phase 1 DMC

• 1 other identifier: CQ012019
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Congestive Heart Failure

Outcome Measures

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.

  Up to 7 months from randomization

Secondary Outcomes (10)

• 6 min Walking distance

  At 3, 6 and 7 months from randomization

• Quality of life tested with Kansas City Cardiomyopathy Questionnaire (KCCQ)

  At 3, 6 and 7 months from randomization

• Number of patients with decrease of NT pro-BNP (N-terminal pro brain natriuretic peptide)

  At 3, 6 and 7 months from randomization

• Worsening of renal function

  Up to 7 months from randomization

• Cumulative daily dosage of loop diuretic

  Up to 7 months from randomization

Study Arms (2)

PolyCore PUF

EXPERIMENTAL

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

Drug: PolyCore (Polydextrin, L-Carnitine, D-xylitol)

Control

NO INTERVENTION

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

Interventions

PolyCore (Polydextrin, L-Carnitine, D-xylitol) DRUG

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.

Also known as: PolyCore peritoneal dialysis solution

PolyCore PUF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Iperboreal Pharma Srl: lead

Study Sites (3)

Ospedale Ss. Annunziata

Chieti, Italy

RECRUITING

ASST FBF Sacco

Milan, Italy

RECRUITING

Ospedale Monaldi

Napoli, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Carnitine; Xylitol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Sugar Alcohols; Alcohols; Carbohydrates

Study Officials

• Edoardo Gronda, MD

  Policlinico Milano - on behalf of Cardio Renal and Metabolism Working Group of the ANMCO

  STUDY DIRECTOR

Central Study Contacts

Arduino Arduini, MD

CONTACT

+41 79 7878312; a.arduini@corequest.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded independent review committee, comprised of experienced cardiologist and nephrologists, who are non-participating investigators in this study, will be appointed to confirm the primary end-point.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 no PUF therapy.

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: April 16, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)