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NCT02546583 · ClinicalTrials.gov registry record · Phase 1
Diagnosing and Targeting Mechanisms of Diuretic Resistance in Heart Failure
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 458
- Enrollment target
NCT02546583: Completed Phase 1 study, sponsored by Yale University.
NCT02546583 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 458 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (663% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02546583, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 458 participants
- Enrollment target
Study Summary
Effective diuresis is the primary goal of most acute decompensated heart failure hospitalizations, but diuretic resistance is common and our ability to detect it is limited. Further, there are therapeutically distinct groups of diuretic-resistant patients. These are not easily distinguished using currently available methods, leading to trial-and-error based treatment that promotes lengthy hospitalizations. The aims of this study are: 1. To develop inexpensive and efficient tools to predict diuretic response 2. To understand the prevalence of therapeutically targetable mechanisms of diuretic resistance using endogenous lithium clearance 3. To develop methodology to differentiate diuretic resistance mechanisms using common/inexpensive laboratory tests 4. To provide proof of concept that mechanistically tailored diuretic therapy can improve natriuresis
Primary Outcome
Suboptimal Natriuretic Response is defined as a measured sodium output of \<100 mmol in the 6 hours following the dose of diuretic
Interventions
- DRUG Increased Intravenous Bolus Loop Diuretic Dose (Bumetanide or Furosemide)
- DRUG IV Chlorothiazide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 458 participants |
| Start Date | 2015-08-31 |
| Est. Completion | 2020-01-23 |
| Phase | Phase 1 |
What the finished NCT02546583 record still lists
NCT02546583 is an interventional study that assigns participants to a tested intervention. The registered 458 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (663% higher).
The record links to 0 conditions, and to 2 interventions - of which Increased Intravenous Bolus Loop Diuretic Dose (Bumetanide or Furosemide) is the first listed.
NCT02546583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02546583 about?
NCT02546583 is a clinical study titled "Diagnosing and Targeting Mechanisms of Diuretic Resistance in Heart Failure". Effective diuresis is the primary goal of most acute decompensated heart failure hospitalizations, but diuretic resistance is common and our ability to detect it is limited. Further, there are therapeutically distinct groups of diuretic-resistant patients. These are not easily distinguished using cu...
What is the current status of trial NCT02546583?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 458 participants. The study started on 2015-08-31. Estimated completion is 2020-01-23.
What interventions are being tested in trial NCT02546583?
The interventions under investigation include: Increased Intravenous Bolus Loop Diuretic Dose (Bumetanide or Furosemide) (DRUG), IV Chlorothiazide (DRUG).
Who is sponsoring clinical trial NCT02546583?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02546583's enrollment target sits among peer trials
458 54th of 2000 higher than 1,947 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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