Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT03994874

Peritoneal Ultrafiltration in Cardio Renal Syndrome.

Led by Iperboreal Pharma Srl · Updated on 2025-05-16

84

Participants Needed

3

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Peritoneal Ultrafiltration in Cardio Renal Syndrome.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Left ventricular ejection fraction 40% or less
  • New York Heart Association (NYHA) Class III or IV despite guideline-directed medical therapy
  • Right ventricular failure indicated by moderate or greater tricuspid valve regurgitation and a right atrial pressure to capillary wedge pressure ratio of 0.65 or higher
  • Enlarged cava vein with inner diameter between 1.5 and 2.5 cm and reduced respiratory collapse due to fluid overload
  • Kidney function with glomerular filtration rate above 15 ml/min/1.73 m2
  • NT pro-BNP level above 1000 pg/ml or BNP level above 250 pg/ml
  • At least one episode of pulmonary or systemic congestion needing high-dose intravenous diuretics in the last 6 months
  • Suitable candidate for peritoneal ultrafiltration technique
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • History of heart transplantation
  • Presence of mechanical circulatory support device
  • Hypertrophic obstructive cardiomyopathy
  • Uncontrolled high blood pressure with systolic pressure 160 mmHg or higher
  • Severe valvular stenosis
  • Restrictive cardiomyopathy
  • Acute coronary syndrome within 6 months
  • Active myocarditis
  • Heart surgery or endo-radiological procedures within 6 months
  • Cardiac resynchronization therapy (CRT) or pacemaker/defibrillator upgrades 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 cancer
  • Female patients who are pregnant, breastfeeding, or planning pregnancy during the study and for three months after
  • Female patients of childbearing age not using adequate contraception
  • Unwilling or unable to give informed consent
  • Participation in another clinical trial involving medical or device interventions
  • Hypersensitivity to investigational medicinal product components
  • Any condition that could expose the participant to undue risk or affect study quality per investigator judgment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

Research Team

A

Arduino Arduini, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here