Condition or disease | Intervention/treatment | Phase |
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Congestive Heart Failure | Drug: PolyCore (Polydextrin, L-Carnitine, D-xylitol) Drug: Medical therapy including loop diuretic (furosemide) daily dose up to 2.5 mg/kg/day, | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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 no PUF therapy. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | A blinded independent review committee, comprised of experienced cardiologist and nephrologists, who are non-participating investigators in this study, will be appointed to confirm the primary end-point. |
Primary Purpose: | Treatment |
Official Title: | Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation. |
Estimated Study Start Date : | March 2021 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | October 2022 |
Arm | Intervention/treatment |
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Experimental: PolyCore PUF
PolyCore peritoneal ultrafiltration (PUF) (over the top of patient's prescribed heart failure medications), for 6 months.
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Drug: PolyCore (Polydextrin, L-Carnitine, D-xylitol)
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 Name: PolyCore peritoneal dialysis solution
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Active Comparator: Control
Patients in the control arm (receiving no PUF therapy) will remain on their prescribed heart failure medications.
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Drug: Medical therapy including loop diuretic (furosemide) daily dose up to 2.5 mg/kg/day,
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.
Other Name: Guidelines directed medical therapy
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Arduino Arduini, MD | +41 79 7878312 | a.arduini@corequest.ch |
Study Director: | Edoardo Gronda, MD | Policlinico Milano |
Tracking Information | |||||
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First Submitted Date ICMJE | June 20, 2019 | ||||
First Posted Date ICMJE | June 21, 2019 | ||||
Last Update Posted Date | February 10, 2021 | ||||
Estimated Study Start Date ICMJE | March 2021 | ||||
Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Composite end-point of mortality and worsening patient's condition [ Time Frame: Up to 6 months ]
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Peritoneal Ultrafiltration in Cardio Renal Syndrome. | ||||
Official Title ICMJE | Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation. | ||||
Brief Summary | 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). | ||||
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 ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 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 no PUF therapy. Masking: Single (Outcomes Assessor)Masking Description: A blinded independent review committee, comprised of experienced cardiologist and nephrologists, who are non-participating investigators in this study, will be appointed to confirm the primary end-point. Primary Purpose: Treatment
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Condition ICMJE | Congestive Heart Failure | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
84 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | October 2022 | ||||
Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03994874 | ||||
Other Study ID Numbers ICMJE | CQ012019 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | CoreQuest, Switzerland | ||||
Study Sponsor ICMJE | CoreQuest, Switzerland | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | CoreQuest, Switzerland | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |