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New treatment option for Congestive Heart Failure
Official title Peritoneal Ultrafiltration in Cardio Renal Syndrome.
ClinicalTrials.gov ID: NCT03994874
What this study is testing
What is PolyCore (Polydextrin, L-Carnitine, D-xylitol)?
PolyCore (Polydextrin, L-Carnitine, D-xylitol) is an investigational medicine, being studied as a potential treatment for congestive heart failure.
Also referred to as PolyCore peritoneal dialysis solution.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Cava vein enlargement (inner diameter, detected with focused echocardiography, between 1,5 and 2,5 cm, with respiratory collapse \<50% or absent due...
You likely can't join 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;
See the full eligibility 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...
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chieti, Italy
- Milan, Italy
- Naples, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chieti, Italy; Milan, Italy; Naples, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.