Actively Recruiting
Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation
Led by Iperboreal Pharma Srl · Updated on 2025-05-16
84
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of PolyCore peritoneal ultrafiltration (PUF) in adults with heart failure and reduced ejection fraction (HFrEF) who continue to experience symptoms despite standard medical treatment. This randomized, controlled, unblinded trial aims to compare PolyCore PUF plus usual heart failure medications versus stable medical therapy alone in this population. The study includes an adaptive design with an interim analysis to determine final study size, overseen by an independent safety monitoring board. Participants are randomly assigned to one of two groups: one receiving PolyCore PUF treatment for six months alongside their regular heart failure medications, and the other receiving only stable medical therapy including loop diuretics without PUF. The PolyCore PUF involves a single nightly exchange of 2 liters of PolyCore solution lasting 12 to 14 hours each night over six months. The control group continues their prescribed medications without PUF therapy. During the study, participants will be monitored through several assessments including walking distance tests, quality of life questionnaires, measurement of heart failure biomarkers, kidney function, medication usage, hospital resource use, and heart failure severity classification. These evaluations occur at 3, 6, and 7 months after randomization, with safety monitored throughout approximately one year. The primary outcome is a combined measure of mortality and worsening heart failure condition up to seven months after starting treatment.
CONDITIONS
Brief Title
Peritoneal Ultrafiltration in Cardio Renal Syndrome.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Left ventricular ejection fraction 40% or less
- NYHA Class III-IV symptoms despite guideline-directed medical therapy
- Moderate or greater tricuspid valve regurgitation and right ventricular failure signs confirmed by right heart catheterization
- Cava vein enlargement with respiratory collapse less than 50% or absent
- Kidney function with glomerular filtration rate above 15 ml/min/1.73 m2
- NT pro-BNP plasma concentration above 1000 pg/ml or BNP above 250 pg/ml
- At least one episode of pulmonary or systemic congestion requiring high-dose intravenous diuretics in the past 6 months
- Candidate suitable for peritoneal ultrafiltration technique
- Signed informed consent
You will not qualify if you...
- Recipient of heart transplantation
- Presence of mechanical circulatory support device
- Hypertrophic obstructive cardiomyopathy
- Uncontrolled hypertension with systolic blood pressure 160 mmHg or higher
- Severe valvular stenosis
- Restrictive cardiomyopathy
- Acute coronary syndrome within 6 months
- Active myocarditis
- Cardiac surgery or endo-radiological heart procedures within 6 months
- Cardiac resynchronization therapy or pacemaker/ICD upgrade within 6 months
- End-stage renal disease with glomerular filtration rate below 15 ml/min/1.73 m2
- Major organ transplant (liver, lung, kidney)
- Lung embolism within 6 months
- Fibrotic lung disease
- Liver cirrhosis
- Absolute contraindication to peritoneal catheter implantation
- Logistical or organizational contraindications to treatment
- Active malignancy
- Female patients who are pregnant, breastfeeding, or planning pregnancy during the trial and 3 months after
- Female patients of childbearing age not using adequate contraception
- Unable or unwilling to give informed consent
- Participation in another clinical trial involving medical or device interventions
- Hypersensitivity to investigational medicinal product components
- Any condition that poses undue risk or interferes with study participation or data quality according to investigators' judgment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants are assigned to receive either nightly peritoneal ultrafiltration using PolyCore solution for 6 months alongside their prescribed heart failure medications, or to continue stable medical therapy without ultrafiltration.
Monthly visits during treatment
Duration - Up to 6 months after treatment completion
Participants are monitored for up to 1 year to assess outcomes including quality of life, heart failure symptoms, and adverse events.
Visits at 7 months and additional long-term follow-ups
Trial Site Locations
Total: 3 locations
1
Ospedale Ss. Annunziata
Chieti, Italy
Actively Recruiting
2
ASST FBF Sacco
Milan, Italy
Actively Recruiting
3
Ospedale Monaldi
Naples, Italy
Actively Recruiting
Research Team
A
Arduino Arduini, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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