Pulmonary HypertensionNCT01913457
Measurements and Characterization of Doppler Signals From the Right Chest in Pediatric and Adult Patients
An observational study of Pulmonary Hypertension, run by Echosense Ltd. at 2 sites in United States.
Trial summary
Recently it has been shown that clear reproducible Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package parametric Doppler, TPD, EchoSense Ltd., Haifa, Israel). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Ultrasound Doppler
- Type of treatment
- Surgery or procedure
- How many people
- 230 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to 1 Jul 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study targets to enroll 200 patients (see inclusion criteria): 100 patients will be children without cardiopulmonary diseases, 50 patients will be children undergoing heart catheterization, 50 patients will be adults undergoing heart catheterization
Who may be able to join
- Adults undergoing RHC:
- Males or females aged over 18 years
- With suspicion or diagnosis of pulmonary hypertension.
- Scheduled to undergo right heart catheterization
- Able and willing to give informed consent
- Pediatric patients undergoing RHC:
Show all 12Show fewer
- Males or females aged 0-18 years
- Scheduled to undergo right hear catheterization
- Parents willing to give informed consent
- Pediatric patients without significant cardio-pulmonary diseases:
- Males or females aged 0-18 years Not known to have a significant cardiac or pulmonary disease
- Legal guardians willing to give informed consent
Who cannot join
- -Hemodynamically unstable patients.
- For adult and pediatric patients undergoing right heart catheterization:
- Any contra-indication to perform the procedure
- For adults only:
- Patients incapable of performing a Valsalva maneuver
- Patients with recent (within the past 3 months) myocardial infarction, high degree AV block, severe aortic stenosis or open angle glaucoma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford Hospital and Clinics and Lucile Packard Children's Hospital
Palo Alto, California
Stanford university hospital
Palo Alto, California
About this study
Official title: Evaluation of Lung Doppler Signals in Pediatric and Adult Patients
Recently it has been shown that clear reproducible Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package parametric Doppler, TPD, EchoSense Ltd., Haifa, Israel). These lung Doppler signals (LDS) are in full synchrony with the cardiac cycle and can be obtained from the lungs, including areas remote from the heart and main pulmonary vessels. The LDS waves typically have peak velocities of up to 30 cm/s and are of relatively high power, making it possible to detect them despite the aforementioned attenuation by the air in the lungs. The LDS are thought to represent the radial wall movement of small pulmonary blood vessels, caused by pressure pulse waves of cardiac origin which propagate throughout the lung vasculature. The LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio-vascular system in general.
Pulmonary arterial hypertension (PAH) is a condition characterized by reshaping of the small pulmonary arteries with increase in pulmonary vascular resistance, leading gradually to right-sided cardiac failure. A trans-thoracic echocardiograph (TTE) is a test classically undertaken in order to screen for pulmonary hypertension. However, the systolic pulmonary artery pressure (SPAP) values thereby obtained are often imprecise and depend upon the expertise of the individual carrying out the test. Therefore, the pulmonary arterial pressure and cardiac output values have to be ascertained with a right-sided cardiac catheterization, which is considered the gold-standard, but is invasive.
Read more
In a pilot study of adult PAH patients (unpublished), lung Doppler signals have been shown to have the potential to diagnose pulmonary hypertension in two different ways: First, by measuring the degree of attenuation of the LDS during acute pressure rise in the chest cavity (i.e. during Valsalva maneuver). Second, by detecting differences between the LDS in patients with PAH and control subjects.
One of the objectives of the present study is to evaluate the lung Doppler signals in pediatric patients of various age groups, with and without pulmonary vascular disease. The second objective of the study is to verify previous findings of abnormal lung Doppler signals in adult patients with pulmonary hypertension.
- Conditions
- Pulmonary Hypertension
- Being tested
- Ultrasound Doppler
- Keywords
- Ultrasound Doppler, Lungs, Pulmonary artery hypertension
- Medical subject headings
- Hypertension, Pulmonary, Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound DopplerRadiation
Doppler Ultrasound recording on external right chest wall
| Study group | Role | What they receive |
|---|---|---|
| Adults w/ PH | Subjects above 18y scheduled to undergo RHC for Doppler ultrasound external right chest wall tests Receives: Radiation: Ultrasound Doppler | |
| Children w/ PH | Children 0-18y old scheduled to RHC Receives: Radiation: Ultrasound Doppler | |
| Children control | Children 0-18y old w/o PH for Lung Doppler tests as controls Receives: Radiation: Ultrasound Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnose specific pattern of LDS in children by features as velocity & power in comparison to adult LDS pattern.
Measured: 1 year to collect all data and obtain an average diagnostic pattern
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startJul 2013
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery Feinstein, MD, Principal investigator, Stanford Hospital and Clinics and Lucile Packard Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913457
- Sponsor's protocol ID
- DOP018/25388
- Status last verified
- Jun 2019
- First submitted
- 25 Jul 2013
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Doppler Signals in Pediatric and Adult Patients
- ClinicalTrials.gov ID
- NCT01913457
- Acronym / sponsor ID
- DOP018/25388
- Conditions
- Pulmonary Hypertension
- Keywords
- Ultrasound Doppler, Lungs, Pulmonary artery hypertension
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2013 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 1 Aug 2013 (estimated)
- 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.
Recently it has been shown that clear reproducible Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package parametric Doppler, TPD, EchoSense Ltd., Haifa, Israel). These lung Doppler signals (LDS) are in full synchrony with the cardiac cycle and can be obtained from the lungs, including areas remote from the heart and main pulmonary vessels. The LDS waves typically have peak velocities of up to 30 cm/s and are of relatively high power, making it possible to detect them despite the aforementioned attenuation by the air in the lungs. The LDS are thought to represent the radial wall movement of small pulmonary blood vessels, caused by pressure pulse waves of cardiac origin which propagate throughout the lung vasculature. The LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio-vascular system in general.
Pulmonary arterial hypertension (PAH) is a condition characterized by reshaping of the small pulmonary arteries with increase in pulmonary vascular resistance, leading gradually to right-sided cardiac failure. A trans-thoracic echocardiograph (TTE) is a test classically undertaken in order to screen for pulmonary hypertension. However, the systolic pulmonary artery pressure (SPAP) values thereby obtained are often imprecise and depend upon the expertise of the individual carrying out the test. Therefore, the pulmonary arterial pressure and cardiac output values have to be ascertained with a right-sided cardiac catheterization, which is considered the gold-standard, but is invasive.
In a pilot study of adult PAH patients (unpublished), lung Doppler signals have been shown to have the potential to diagnose pulmonary hypertension in two different ways: First, by measuring the degree of attenuation of the LDS during acute pressure rise in the chest cavity (i.e. during Valsalva maneuver). Second, by detecting differences between the LDS in patients with PAH and control subjects.
One of the objectives of the present study is to evaluate the lung Doppler signals in pediatric patients of various age groups, with and without pulmonary vascular disease. The second objective of the study is to verify previous findings of abnormal lung Doppler signals in adult patients with pulmonary hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adults w/ PH | – | Radiation: Ultrasound DopplerSubjects above 18y scheduled to undergo RHC for Doppler ultrasound external right chest wall tests |
| Children w/ PH | – | Radiation: Ultrasound DopplerChildren 0-18y old scheduled to RHC |
| Children control | – | Radiation: Ultrasound DopplerChildren 0-18y old w/o PH for Lung Doppler tests as controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study targets to enroll 200 patients (see inclusion criteria): 100 patients will be children without cardiopulmonary diseases, 50 patients will be children undergoing heart catheterization, 50 patients will be adults undergoing heart catheterization
Key inclusion criteria (12 listed)
- Adults undergoing RHC:
- Males or females aged over 18 years
- With suspicion or diagnosis of pulmonary hypertension.
- Scheduled to undergo right heart catheterization
- Able and willing to give informed consent
Key exclusion criteria (6 listed)
- -Hemodynamically unstable patients.
- For adult and pediatric patients undergoing right heart catheterization:
- For adults only:
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 |
|---|---|---|
| Ultrasound DopplerDoppler Ultrasound recording on external right chest wall | Radiation | Adults w/ PH, Children control, Children w/ PH |
Primary outcome
Diagnose specific pattern of LDS in children by features as velocity & power in comparison to adult LDS pattern.
Time frame: 1 year to collect all data and obtain an average diagnostic pattern
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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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.
Jeffery Feinstein, MD principal investigator
Stanford Hospital and Clinics and Lucile Packard Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Echosense Ltd. at 2 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 12 inclusion and 6 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 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Diagnose specific pattern of LDS in children by features as velocity & power in comparison to adult LDS pattern. (time frame: 1 year to collect all data and obtain an average diagnostic pattern). 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 23 Mar 2022.