Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510601
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2007-07-31
Brief Title:
Treating Congestive Heart Failure Using a Device to Remove Cholesterol
Sponsor:
Patrick Moriarty MD FACP FACC
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
LDL Apheresis for the Treatment of 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:
A pilot study to examine the effects of LDL-Apheresis on patients with Stage III Congestive Heart Failure
Study hypothesis Decreased blood viscosity from receiving LDL-apheresis will decrease workload on the heart and improve symptoms associated with the progression of Congestive Heart Failure
Study hypothesis Decreased blood viscosity from receiving LDL-apheresis will decrease workload on the heart and improve symptoms associated with the progression of Congestive Heart Failure
Detailed Description:
Patients who qualify for the study will receive 7 bi-weekly LDL-Apheresis treatments with the Kaneka Liposorber device Patients will assess their CHF symptoms using the KC Cardiomyopathy questionnaire prior to each treatment Blood levels of certain indices related to CHF and safety profile labs will be drawn before and after the first and last treatment
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