Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-30 @ 12:03 PM
Study NCT ID:
NCT01733134
Status:
WITHDRAWN
Last Update Posted:
2024-11-20
First Post:
2012-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Heart Failure Patients With High Copeptin Treated With Tolvaptan Targets Increased AVP Activation for Treatment (ACTIVATE)
Sponsor:
Maisel, Alan, M.D.
Organization:
Study Overview
Official Title:
Acute Heart Failure With High Copeptin Levels Treated With Tolvaptan Targets Increased AVP Activation for Treatment Efficacy
Status:
WITHDRAWN
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decided to quit funding before any enrollments
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:
True
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?: