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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 is a Phase 4 study that has completed, run by The Christ Hospital. The registered enrollment target is 45 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01863511
The ClinicalTrials.gov registry entry for NCT01863511 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Christ Hospital, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which tolvaptan is the first listed.
NCT01863511 reports 0 study locations.
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.
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