ADHFNCT03998410
Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea
A study testing Lung Doppler Signals in people with ADHF, run by Echosense Ltd. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADHF
- What is being tested?
- Lung Doppler Signals
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Sep 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The university of Texas Southwestern Medical Center
Dallas, Texas, 75390
Wayne State University
Detroit, Michigan, 48201
Baylor College of Medicine
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- ADHF
- Being tested
- Lung Doppler Signals
- Keywords
- ADHF Dyspnea ED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Doppler SignalsDevice
Recording Doppler ultrasound on the right chest wall
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of diagnosis
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
Measured: Average of 1 year
Secondary outcomes (1)
Sensitivity, Specificity, PPV, NPV of TPD diagnosis
Calculate the analysis success parameters
Measured: Average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start15 Sep 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: due to the pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Recording Doppler US signals over the right wall chest
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judd Hollander, MD, Principal investigator, judd.hollander@jefferson.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998410
- Sponsor's protocol ID
- DOP-27
- Status last verified
- Jun 2020
- First submitted
- 23 Jun 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea
- ClinicalTrials.gov ID
- NCT03998410
- Acronym / sponsor ID
- DOP-27
- Conditions
- ADHF
- Keywords
- ADHF Dyspnea ED
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to the pandemic
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Model description
- Recording Doppler US signals over the right wall chest
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Doppler SignalsRecording Doppler ultrasound on the right chest wall | Device | – |
Primary outcome
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
1 secondary outcome
Sensitivity, Specificity, PPV, NPV of TPD diagnosis
Time frame: Average of 1 year
Results and safety
The study was stopped early (reason given: due to the pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for ADHF
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Acute Decompensated Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judd Hollander, MD principal investigator
judd.hollander@jefferson.edu
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Doppler Signals in people with ADHF, run by Echosense Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to the pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of diagnosis (time frame: Average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.