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Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea

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ClinicalTrials.gov Identifier: NCT03998410
Recruitment Status : Suspended (due to the pandemic)
First Posted : June 26, 2019
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Echosense Ltd.

Brief Summary:
The objective of this study is to evaluate Lung Doppler signals (LDS) among patients presenting to the emergency department with acute dyspnea, in order to determine the diagnostic value of this non-invasive method to discriminate ADHF causing dyspnea from any other cause i.e., non-ADHF causes of dyspnea.

Condition or disease Intervention/treatment Phase
ADHF Device: Lung Doppler Signals Not Applicable

Detailed Description:

Dyspnea (shortness of breath) is a common symptom affecting as many as 25% of patients seen in ambulatory settings. It can be caused by many different underlying conditions, some of which arise acutely and can be life-threatening, making rapid clinical evaluation and targeted diagnostic studies of central importance. A number of disorders cause dyspnea, including acute decompensated heart failure (ADHF), chronic obstructive pulmonary disease (COPD), asthma, pulmonary embolism, pneumonia, metabolic acidosis, neuromuscular weakness, and others. The overlapping clinical presentations of these conditions and comorbid diseases can make the diagnostic evaluation of dyspnea a significant challenge.

Acute heart failure (AHF) is a major cause of serious morbidity and death in the general population and one of the most common medical causes of hospitalization among people aged over 60. Patients presenting to the ED with ADHF must be evaluated and treated rapidly to ensure the best possible outcomes. The diagnosis should be made as soon as possible and therapy initiated. Delayed diagnosis at presentation may also result in patients being inappropriately transferred to non-specialist wards, resulting in longer stays, increased re-admission and poorer outcomes. The key to improving the time to diagnosis depends on the clinical evaluation alongside a readiness to initiate relevant additional tests.

Previous studies showed that the TPD has the potential to differentiate between the cardiac cause of dyspnea and any other cause.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Recording Doppler US signals over the right wall chest
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea
Actual Study Start Date : September 15, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Lung Doppler Signals
    Recording Doppler ultrasound on the right chest wall


Primary Outcome Measures :
  1. Accuracy of diagnosis [ Time Frame: Average of 1 year ]
    overall accuracy of the TPD system for the determination of ADHF causing acute dyspnea in an ED setting versus the gold standard (GS) diagnosis as determined by the final adjudicated diagnosis


Secondary Outcome Measures :
  1. Sensitivity, Specificity, PPV, NPV of TPD diagnosis [ Time Frame: Average of 1 year ]
    Calculate the analysis success parameters



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients with acute onset dyspnea (defined as shortness of breath (SOB) at rest or on exertion) and diagnostic uncertainty of etiology where heart failure is in consideration.
  • Patients designated to undergo chest X-ray as part of standard of care assessment.

Exclusion Criteria:

  • Obvious trauma contributing to dyspnea
  • Inability to provide written informed consent
  • Not speaking English or Spanish
  • Right-sided lobectomy
  • Patients with implanted ventricular assist device
  • Patient is unable to undergo the TPD test
  • Patient is already enrolled in a clinical study with experimental medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998410


Locations
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United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Texas
The university of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Echosense Ltd.
Investigators
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Principal Investigator: Judd Hollander, MD judd.hollander@jefferson.edu
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Responsible Party: Echosense Ltd.
ClinicalTrials.gov Identifier: NCT03998410    
Other Study ID Numbers: DOP-27
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Echosense Ltd.:
ADHF Dyspnea ED
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory