At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 257 enrolled
Drug / intervention
Tolvaptan +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Targeting Acute Congestion With Tolvaptan In Congestive Heart Failure Study
In Brief
A Phase 3 clinical trial evaluating Tolvaptan and Placebo for Heart Failure and Dyspnea. Completed, enrolled 257 participants across 18 sites.
Detailed Summary
The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute decompensated heart failure The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will be more effective at relieving dyspnea than fixed dose furosemide alone
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Dyspnea
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartOct 2012
Primary CompletionFeb 2016
TodayJul 2026
First PostedJul 19, 2012
Enrollment StartOct 1, 2012
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.0 years ago
Interventions
Tolvaptandrug
IV furosemide plusTolvaptan (given at 0, 24 and 48 hours)
Placebodrug
IV furosemide plus oral placebo (given at 0, 24 and 48 hours)