Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-25 @ 1:27 PM
Study NCT ID:
NCT02079259
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2014-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure
Sponsor:
Heinrich-Heine University, Duesseldorf
Organization:
Study Overview
Official Title:
CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure - A Pilot Study to Optimize Individualized Volume Depletion
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Aquadex
Brief Summary:
The number of patients with acute congestion on chronic heart failure is increasing. Ultrafiltration has recently been proposed as an alternative approach for the stabilization of volume balance, especially in patients with imminent diuretic resistance.
There is increasing evidence that ultrafiltration may relief cardiac congestion with lesser effects on blood pressure and activation of renin angiotensin system, respectively . However, recent studies revealed conflicting results: demonstration the superiority of ultrafiltration in comparison to diuretic treatment, and a lack of evidence of benefit, as well as an excess of adverse events with ultrafiltration.
Aquapheresis with adapted ultrafiltration rate guided by central venous pressure is safer than aquaphesis with a constant ultrafiltration with comparable effectiveness
There is increasing evidence that ultrafiltration may relief cardiac congestion with lesser effects on blood pressure and activation of renin angiotensin system, respectively . However, recent studies revealed conflicting results: demonstration the superiority of ultrafiltration in comparison to diuretic treatment, and a lack of evidence of benefit, as well as an excess of adverse events with ultrafiltration.
Aquapheresis with adapted ultrafiltration rate guided by central venous pressure is safer than aquaphesis with a constant ultrafiltration with comparable effectiveness
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: