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AzTrials

Congestive Heart FailurePhase 1/2PURENCT03994874

Peritoneal Ultrafiltration in Cardio Renal Syndrome.

A Phase 1/2 study testing PolyCore (Polydextrin, L-Carnitine, D-xylitol) in people with Congestive Heart Failure, run by Iperboreal Pharma Srl at 3 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure
What is being tested?
PolyCore (Polydextrin, L-Carnitine, D-xylitol)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
3 sitesItaly
Study dates
16 Apr 2025to Jun 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Arduino Arduini, MD contact

+41 79 7878312

a.arduini@corequest.ch

Italy3 sites, 3 recruiting

  • Ospedale Ss. Annunziata

    Chieti

    Mario Bonomini, MD

    Recruiting

  • ASST FBF Sacco

    Milan

    Maurizio Gallieni, MD

    Recruiting

  • Ospedale Monaldi

    Naples

    Giuseppe Pacileo, MD

    Recruiting

Other trials in Italy

About this study

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

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).

Read the detailed description

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.

Being tested
PolyCore (Polydextrin, L-Carnitine, D-xylitol)
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called PolyCore peritoneal dialysis solution

    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.

Study groups in NCT03994874
Study groupRoleWhat they receive
PolyCore PUFExperimentalPolyCore peritoneal ultrafiltration (PUF) (over the top of patient's prescribed heart failure medications), for 6 months.
Receives: Drug: PolyCore (Polydextrin, L-Carnitine, D-xylitol)
ControlNo interventionPatients in the control arm (receiving no PUF therapy) will remain on their prescribed heart failure medications.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 7 months from randomization

Secondary outcomes (10)

  1. 6 min Walking distance

    Change from the baseline

    Measured: At 3, 6 and 7 months from randomization

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

    Change from the baseline

    Measured: At 3, 6 and 7 months from randomization

  3. 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

    Measured: At 3, 6 and 7 months from randomization

  4. Worsening of renal function

    Estimated Glomerular Filtration Rate (eGFR) ≤20 ml/min

    Measured: Up to 7 months from randomization

  5. Cumulative daily dosage of loop diuretic

    Change over the 6 months of study treatment,

    Measured: Up to 7 months from randomization

  6. Use of hospital resources

    The number of days spent in-hospital because of HF exacerbation during the 6 months of study treatment

    Measured: Up to 7 months from randomization

  7. New York Heart Association (NYHA) class

    Change from baseline

    Measured: At 3, 6 and 7 months from randomization and during long-term FUs

  8. Number of patients requiring hospitalization

    Hospitalization for infusional therapy with loop diuretic

    Measured: Up to 7 months from randomization

  9. Number of patients increasing of ≥50% the initial daily dose of loop diuretic

    Change from baseline

    Measured: Up to 7 months from randomization

  10. Adverse Events

    Information about all adverse events, whether volunteered by the patient, discovered by investigator questioning, or detected through physical examination, laboratory or instrumental test, will be collected, recorded and followed as appropriate.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study start16 Apr 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03994874
Sponsor's protocol ID
CQ012019
Acronym
PURE
Status last verified
May 2024
First submitted
20 Jun 2019
Last updated
16 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PolyCore (Polydextrin, L-Carnitine, D-xylitol) in people with Congestive Heart Failure, run by Iperboreal Pharma Srl at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arduino Arduini, MD (+41 79 7878312, a.arduini@corequest.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite end-point of mortality and worsening patient's condition (time frame: Up to 7 months from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03994874.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.

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