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NCT03136198 · ClinicalTrials.gov registry record · Phase 2

B-lines Lung Ultrasound Guided ED Management of Acute Heart Failure Pilot Trial

A Phase 2 study, sponsored by Indiana University.

Completed
Registry status
Phase 2
Development phase
130
Enrollment target

NCT03136198 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 130 participants.

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The verdict

NCT03136198, a Phase 2 study, has completed, sponsored by Indiana University.

COMPLETED
Registry status
Phase 2
Development phase
130 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. The investigators propose a novel approach to aggressively decongest patients in the ED setting: lung ultrasound guided, protocol driven, AHF management. LUS B-lines are a measure of extra-vascular lung water (EVLW). In the setting of AHF, LUS B-lines are a measure of congestion. This simple, easily learned technique has excellent reliability and reproducibility. The investigators hypothesize that a strategy-of-care will outperform usual care. At the present time, usual care is largely empirical. This study will improve the evidence base for ED AHF management. This proposed pilot study, if successful, will lead to an outcome trial examining whether an ED AHF strategy-of-care increases days alive and out of the hospital for patients.

Interventions

  • OTHER Usual Care
  • DRUG Vasodilator
  • OTHER LUS-guided strategy-of-care
  • DRUG Intravenous Loop Diuretic
  • DEVICE Non invasive Ventilation (NIV)

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2017-07-10
Est. Completion 2019-06-20
Phase Phase 2

Sponsor

Indiana University

890 total trials

What the Registry Record Tells You About NCT03136198

The ClinicalTrials.gov registry entry for NCT03136198 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 130 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 5 interventions - of which Usual Care is the first listed.

NCT03136198 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03136198 about?

NCT03136198 is a clinical study titled "B-lines Lung Ultrasound Guided ED Management of Acute Heart Failure 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 NCT03136198?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2017-07-10. Estimated completion is 2019-06-20.

What interventions are being tested in trial NCT03136198?

The interventions under investigation include: Usual Care (OTHER), Vasodilator (DRUG), LUS-guided strategy-of-care (OTHER), Intravenous Loop Diuretic (DRUG), Non invasive Ventilation (NIV) (DEVICE).

Who is sponsoring clinical trial NCT03136198?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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