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Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation (PURE)
EU CTIS ID: 2024-512658-41-00
What this study is testing
Evaluate if the treatment with Peritoneal Ultrafiltration with PolyCore has an impact on the composite endpoint of patient’s mortality or worsening of patient’s condition
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients
- Signed informed consent form for participation in this study
- Left ventricular ejection fraction ≤60%
- NYHA Classification of III-IV
- Persistency of right ventricular failure due to after load mismatch
- Cava vein enlargement (between 1,5 and 2,5 cm, with respiratory collapse <50% or absent due to intravascular fluid overload)
You likely can't join if
- Recipients of heart transplantation within one year prior to the screening
- End-stage renal disease (GFR < 15ml/min/1.73m2)
- Any major organ transplant (liver, lung, kidney)
- Lung embolism ≤ 6 months before screening
- Fibrotic lung disease
- Liver cirrhosis (Child B or C)
See the full eligibility criteria
- Adult patients
- Signed informed consent form for participation in this study
- Left ventricular ejection fraction ≤60%
- NYHA Classification of III-IV
- Persistency of right ventricular failure due to after load mismatch
- Cava vein enlargement (between 1,5 and 2,5 cm, with respiratory collapse <50% or absent due to intravascular fluid overload)
- Decreased kidney function with mGFR between 15 and 60 ml/min/1.73m2
- At least one episode of pulmonary or systemic congestion requiring high-dose intravenous diuretics in the 6 months before the study enrolment
- Appropriate PUF technique candidate
- Recipients of heart transplantation within one year prior to the screening
- End-stage renal disease (GFR < 15ml/min/1.73m2)
- Any major organ transplant (liver, lung, kidney)
- Lung embolism ≤ 6 months before screening
- Fibrotic lung disease
- Liver cirrhosis (Child B or C)
- 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 study and for three months later
- Female patients of childbearing age who do not use adequate contraception
- Presence of a mechanical circulatory support device
- Unwilling or unable to give informed consent
- Enrolment in another clinical trial involving medical or device-based interventions during a) the 30 days before the screening or b) 5-times the half-life of the used investigational product
- Ipersensibility to Icodextrin, L-Carnitine, D-xilitol and other PolyCore 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 affecting the study quality data
- Hypertrophic obstructive cardiomyopathy
- Uncontrolled hypertension with systolic blood pressure ≥ 160 mmHg
- Severe valvular stenosis
- Acute coronary syndrome ≤ 6 months before screening
- Active myocarditis
- Cardiosurgical or Endoradiological heart procedures ≤ 6 month before screening
- CRT implantation or upgrading of PM or ICD to CRT ≤ 6 months before screening
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.