Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360958
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2006-08-03
Brief Title:
Treatment of Severe Heart Failure by Ultrafiltration
Sponsor:
Centro Cardiologico Monzino
Organization:
Centro Cardiologico Monzino
Study Overview
Official Title:
Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure
Status:
COMPLETED
Status Verified Date:
2016-01
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:
None
Brief Summary:
Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy Therefore chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability Ultrafiltration is a simple renal replacement therapy which reduces fluid overload The purpose of this study is to determine whether periodic ultrafiltration sessions maintain patients in stable clinical condition and reduce hospitalisations as well as access to emergency heart failure treatment
Detailed Description:
Patients with severe heart failure New York Heart Association NYHA III-IV and fluid overload will be randomized to ultrafiltration UF group or conventional medical treatment Control group Patients follow-up at least monthly visit for one year Ultrafiltration will be repeated during follow-up in case of body weight gain due to fluid accumulation Ultrafiltration will be performed during short term hospitalization
Study Oversight
Has Oversight DMC:
None
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?:
None