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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 is a Phase 2 study that was terminated before completion, run by Indiana University. The registered enrollment target is 52 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03259165
The ClinicalTrials.gov registry entry for NCT03259165 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nitrates is the first listed.
NCT03259165 reports 0 study locations.
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.
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