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Tolvaptan Treatment to Reverse Worsening Outpatient Heart Failure: Possible Role of Copeptin In Identifying Responders (TROUPER)
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.
Details
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2015-07 |
| Completion | 2021-05-13 |
Conditions
- Congestive Heart Failure
Interventions
- tolvaptan
- Placebo
Primary outcomes
- Change in Body Weight at 48 Hours — Baseline, Day 3 (48 hours)
The primary endpoint for the study will be change in body weight between patients randomized to tolvaptan versus placebo from baseline to 48 hours - Change in Body Weight at 48 Hours Stratified by Copeptin — Baseline, Day 3 (48 hours)
The primary endpoint for the study will be change in body weight between patients randomized to tolvaptan versus placebo from baseline to 48 hours with stratification for baseline copeptin level
Countries
United States