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NCT02183792 · ClinicalTrials.gov registry record · Phase 4
Aquaresis Utility for Hyponatremic Acute Heart Failure Study
A Phase 4 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
NCT02183792: Completed Phase 4 study, sponsored by University of Southern California.
NCT02183792 is a Phase 4 study that has completed, run by University of Southern California. The registered enrollment target is 33 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02183792, a Phase 4 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
Study Summary
Hyponatremia is a common finding in acute heart failure (HF) patients and is associated with worse prognosis. In addition to its prognostic value, hyponatremia may have importance during the acute management of HF. We've recently shown that acute or chronic hyponatremia, especially \<130 mEq/L, was associated with higher loop diuretic dose requirements and more frequent need for escalation of the diuretic regimen to achieve the same level of diuresis as normonatremic HF patients. Aquaresis with tolvaptan represents a potentially advantageous approach to the management of volume overload in HF, especially in patients presenting with concomitant hyponatremia. The purpose of the current study is to prospectively evaluate the comparative efficacy and safety of a tolvaptan-based diuretic regimen compared to conventional diuresis with a furosemide-based regimen on short-term clinical and treatment outcomes in hyponatremic acute HF patients. This will be a prospective, open-label, parallel-group, randomized study comparing a tolvaptan-based aquaretic regimen to a conventional continuous infusion loop diuretic-based regimen of furosemide. Up to 55 (target sample size of 50) adult subjects admitted with acute HF and signs of volume overload, and serum sodium less than 135 mEq/L will be randomized to tolvaptan or furosemide treatment arms. The initial 24 hours of study treatment will compare tolvaptan monotherapy to furosemide monotherapy. After the initial 24 hours, treatment regimens may be altered to achieve desired clinical goals. Patients will be followed for up to 96 hours and at discharge for study purposes.
Interventions
- DRUG Furosemide
- DRUG Tolvaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2014-12 |
| Est. Completion | 2018-03 |
| Phase | Phase 4 |
What the finished NCT02183792 record still lists
NCT02183792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Furosemide is the first listed.
NCT02183792 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02183792 about?
NCT02183792 is a clinical study titled "Aquaresis Utility for Hyponatremic Acute Heart Failure Study". Hyponatremia is a common finding in acute heart failure (HF) patients and is associated with worse prognosis. In addition to its prognostic value, hyponatremia may have importance during the acute management of HF. We've recently shown that acute or chronic hyponatremia, especially \<130 mEq/L, was ...
What is the current status of trial NCT02183792?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2014-12. Estimated completion is 2018-03.
What interventions are being tested in trial NCT02183792?
The interventions under investigation include: Furosemide (DRUG), Tolvaptan (DRUG).
Who is sponsoring clinical trial NCT02183792?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02183792's enrollment target sits among peer trials
33 1528th of 2000 higher than 467 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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