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NCT01863511 · ClinicalTrials.gov registry record · Phase 4
Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure
A Phase 4 study, sponsored by The Christ Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
NCT01863511: Completed Phase 4 study, sponsored by The Christ Hospital.
NCT01863511 is a Phase 4 study that has completed, run by The Christ Hospital. The registered enrollment target is 45 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01863511, a Phase 4 study, has completed, sponsored by The Christ Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
Study Summary
For patients hospitalized with acute decompensated heart failure,volume removal remains the primary therapeutic objective. The current standard of care remains loop diuretics.The high likelihood of readmissions and poor outcomes highlights the need to examine and improve in-hospital protocols for these patients. Ultrafiltration allows for greater volume removal, less neurohormonal stimulation and greater sodium removal.However it is associated with increased costs, line complications, and relative immobility during treatment. Tolvaptan in addition to diuretic therapy has been shown to improve the amount of volume removed compared to diuretic alone. The study proposes to compare the strategy of adding tolvaptan to usual care with ultrafiltration as primary mode of therapy in acute decompensated HF(ADHF) patients. Hypothesis: addition of tolvaptan to usual care for hospitalized HF patients will result in: * greater volume and weight reduction compared with usual care * similar efficacy outcomes compared with ultrafiltration, with less complications of therapy
Interventions
- DRUG tolvaptan
- DRUG loop diuretic
- PROCEDURE ultrafiltration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
What the finished NCT01863511 record still lists
NCT01863511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which tolvaptan is the first listed.
NCT01863511 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01863511 about?
NCT01863511 is a clinical study titled "Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure". For patients hospitalized with acute decompensated heart failure,volume removal remains the primary therapeutic objective. The current standard of care remains loop diuretics.The high likelihood of readmissions and poor outcomes highlights the need to examine and improve in-hospital protocols for th...
What is the current status of trial NCT01863511?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 2013-05. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01863511?
The interventions under investigation include: tolvaptan (DRUG), loop diuretic (DRUG), ultrafiltration (PROCEDURE).
Who is sponsoring clinical trial NCT01863511?
This trial is sponsored by The Christ Hospital, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01863511's enrollment target sits among peer trials
45 1354th of 2000 higher than 638 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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