CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 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.

Search/NCT02476409
NCT02476409Phase 4Completed

Tolvaptan Treatment to Reverse Worsening Outpatient Heart Failure: Possible Role of Copeptin In Identifying Responders (TROUPER)

University of North Carolina, Chapel Hill·interventional·Posted Jun 19, 2015·Updated May 5, 2022

In Brief

A Phase 4 clinical trial evaluating tolvaptan and Placebo for Congestive Heart Failure. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Patients who present to clinic or in the outpatient setting with worsening heart failure represent a unique opportunity for novel approaches to decongestion (removing fluid) that may more rapidly improve fluid status and symptoms as well as reduce the risk of hospitalization. In these patients with less severe congestion (fluid overload), combining the vasopressin antagonist tolvaptan with loop diuretics (or fluid pills like furosemide/bumetanide/torsemide) may represent a more effective strategy for decongestion. In addition, looking at patients' copeptin levels may help identify those who are more likely to respond to tolvaptan.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 19, 2015
Enrollment StartJul 1, 2015
Primary CompletionMay 13, 2021
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 11.0 years ago

Interventions

tolvaptandrug

Study will test the addition of tolvaptan to augmentation of loop diuretic as standard of care for outpatients presenting with worsening heart failure.

Placeboother

Placebo for tolvaptan