Ignite Creation Date:
2024-05-06 @ 1:20 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03994874
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2019-06-20
Brief Title:
Peritoneal Ultrafiltration in Cardio Renal Syndrome
Sponsor:
Iperboreal Pharma Srl
Organization:
Iperboreal Pharma Srl
Study Overview
Official Title:
Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PURE
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 25mgkgday 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 sizeThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None