- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03994874
Peritoneal Ultrafiltration in Cardio Renal Syndrome. (PURE)
March 5, 2024 updated by: Iperboreal Pharma Srl
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
84
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arduino Arduini, MD
- Phone Number: +41 79 7878312
- Email: a.arduini@corequest.ch
Study Locations
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Chieti, Italy
- Ospedale Ss. Annunziata
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Contact:
- Mario Bonomini, MD
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Milano, Italy
- ASST FBF Sacco
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Contact:
- Maurizio Gallieni, MD
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Napoli, Italy
- Ospedale Monaldi
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Contact:
- Giuseppe Pacileo, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion 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 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)
- 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
Exclusion Criteria:
- 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 study quality data.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PolyCore PUF
PolyCore peritoneal ultrafiltration (PUF) (over the top of patient's prescribed heart failure medications), for 6 months.
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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.
Other Names:
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No Intervention: Control
Patients in the control arm (receiving no PUF therapy) will remain on their prescribed heart failure medications.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite end-point of mortality and worsening patient's condition
Time Frame: Up to 7 months from randomization
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Up to 7 months from randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 min Walking distance
Time Frame: At 3, 6 and 7 months from randomization
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Change from the baseline
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At 3, 6 and 7 months from randomization
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Quality of life tested with Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: At 3, 6 and 7 months from randomization
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Change from the baseline
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At 3, 6 and 7 months from randomization
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Number of patients with decrease of NT pro-BNP (N-terminal pro brain natriuretic peptide)
Time Frame: At 3, 6 and 7 months from randomization
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The number of patients with a decrease in NT pro-BNP level of ≥25% from baseline
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At 3, 6 and 7 months from randomization
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Worsening of renal function
Time Frame: Up to 7 months from randomization
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Estimated Glomerular Filtration Rate (eGFR) ≤20 ml/min
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Up to 7 months from randomization
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Cumulative daily dosage of loop diuretic
Time Frame: Up to 7 months from randomization
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Change over the 6 months of study treatment,
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Up to 7 months from randomization
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Use of hospital resources
Time Frame: Up to 7 months from randomization
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The number of days spent in-hospital because of HF exacerbation during the 6 months of study treatment
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Up to 7 months from randomization
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New York Heart Association (NYHA) class
Time Frame: At 3, 6 and 7 months from randomization and during long-term FUs
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Change from baseline
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At 3, 6 and 7 months from randomization and during long-term FUs
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Number of patients requiring hospitalization
Time Frame: Up to 7 months from randomization
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Hospitalization for infusional therapy with loop diuretic
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Up to 7 months from randomization
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Number of patients increasing of ≥50% the initial daily dose of loop diuretic
Time Frame: Up to 7 months from randomization
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Change from baseline
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Up to 7 months from randomization
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Adverse Events
Time Frame: through study completion, an average of 1 year
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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.
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through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Edoardo Gronda, MD, Policlinico Milano - on behalf of Cardio Renal and Metabolism Working Group of the ANMCO
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
June 20, 2019
First Submitted That Met QC Criteria
June 20, 2019
First Posted (Actual)
June 21, 2019
Study Record Updates
Last Update Posted (Estimated)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CQ012019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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