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NCT03259165 · ClinicalTrials.gov registry record · Phase 2
Nitroglycerin vs. Furosemide Using Lung Ultrasound Pilot Trial
A Phase 2 study, sponsored by Indiana University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT03259165: Clinical Trial Phase 2 study, sponsored by Indiana University.
NCT03259165 is a Phase 2 study that was terminated before completion, run by Indiana University. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03259165, a Phase 2 study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
Nearly 80% of acute heart failure (AHF) patients admitted to the hospital are initially treated in the emergency department (ED). Once admitted, within 30 days post-discharge, 27% of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies have all failed. The evidence for existing AHF therapies are poor: No currently used AHF treatment is known to improve outcomes. ED treatment is largely the same today as 40 years ago. Congestion, such as difficulty breathing, weight gain, and leg swelling, is the primary reason why patients present to the hospital for AHF. Treating congestion is the cornerstone of AHF management. Yet half of all AHF patients leave the hospital inadequately decongested. Although it is the investigators' belief patients are often inadequately decongested in the ED, it is common teaching within emergency medicine to focus on vasodilators and avoid or minimize diuretics, especially in those patients with elevated blood pressure. This practice is largely driven by retrospective analyses or small studies suggesting vasodilators are efficacious and IV loop diuretics may be associated with harm. The evidence base to guide early ED management is poor, and the AHA/ACC guidelines provide little to no guidance for ED treatment. This reflects the lack of high quality data, a critical unmet need that the investigators will address in this study. Using clearance of LUS B-lines as the study endpoint, the investigators will study whether a diuretic intense vs. nitrate intense strategy achieves better decongestion. Although nearly two decades old, a small study of 100 patients suggested a nitrate intense strategy led to better outcomes in AHF patients with pulmonary edema when compared with a diuretic intense strategy. The investigators aim to perform a small pilot study, in hypertensive patients (SBP \> 140mmHg) to test such a strategy to inform a larger, more definitive multicenter randomized trial.
Primary Outcome
The total number of B-lines at the conclusion of ED AHF management or maximum of 6 hours after enrollment, whichever comes first.
Interventions
- DRUG Nitrates
- DRUG Loop Diuretics
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-12-14 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 2 |
Why NCT03259165 stopped before completion
NCT03259165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Nitrates is the first listed.
NCT03259165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03259165 about?
NCT03259165 is a clinical study titled "Nitroglycerin vs. Furosemide Using Lung Ultrasound Pilot Trial". Nearly 80% of acute heart failure (AHF) patients admitted to the hospital are initially treated in the emergency department (ED). Once admitted, within 30 days post-discharge, 27% of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies have all failed. The evidence ...
What is the current status of trial NCT03259165?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2017-12-14. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT03259165?
The interventions under investigation include: Nitrates (DRUG), Loop Diuretics (DRUG).
Who is sponsoring clinical trial NCT03259165?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03259165's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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