Ignite Creation Date:
2024-05-06 @ 1:07 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01733134
Status:
UNKNOWN
Last Update Posted:
2013-01-18
First Post:
2012-11-20
Brief Title:
Acute Heart Failure Patients With High Copeptin Treated With Tolvaptan Targets Increased AVP Activation for Treatment ACTIVATE
Sponsor:
Maisel Alan MD
Organization:
Maisel Alan MD
Study Overview
Official Title:
Acute Heart Failure With High Copeptin Levels Treated With Tolvaptan Targets Increased AVP Activation for Treatment Efficacy
Status:
UNKNOWN
Status Verified Date:
2013-01
Last Known Status:
NOT_YET_RECRUITING
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:
ACTIVATE
Brief Summary:
Patients being hospitalized for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo based on the level of copeptin measured in their bloodstream Patients with high copeptin levels will be able to participate in the trial patients with low levels will be excluded Patients being admitted to the observation unit for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo without consideration of the copeptin level The hypothesis is that patients receiving tolvaptan will have better improvement of shortness of breath than those receiving placebo within 9 hours of drug administration
Detailed Description:
None
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