Pulmonary Arterial HypertensionPhase 1NCT01357746
Measuring Blood Pressure in the Lung Circulation With Sonar Technology (Echo-Doppler)
A Phase 1 study testing Transthoracic pulmonary doppler recording in people with Pulmonary Arterial Hypertension, run by Echosense Ltd. at 1 site in Israel.
Trial summary
This is a non-invasive study using a standard doppler echocardiographic transducer which records signals emanating from the lungs (TPD). These signals are caused by pulsation of blood vessels in the lung tissue. The innovations in this study are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Transthoracic pulmonary doppler recording
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Jun 2012
- Phase
- Phase 1
- 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
- Eligibility
- Age 18 years or older
- Patients who are clinically suspected of having elevated pulmonary blood pressure , due to cardiac or cardio-pulmonary disease preferably any one or more of the conditions listed below, and due to have right heart catheterization as part of the diagnostic work-up:
- Patients with CHF
- Patients with primary pulmonary arterial hypertension
- Patients with COPD
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- Patients with asthma
- Patients with interstitial lung disease
- Patients with sarcoidosis
- Signed informed consent.
Who cannot join
- Patients unable to cooperate.
- Inability to assume a sitting or supine position
- Patients with severe chest wall deformity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection, Estimation and Characterization of Pulmonary Blood Pressure by Transthoracic Parametric Doppler (TPD)
This is a non-invasive study using a standard doppler echocardiographic transducer which records signals emanating from the lungs (TPD). These signals are caused by pulsation of blood vessels in the lung tissue.
The innovations in this study are:
Read more
- The software processing of the reflected ultra-sound waves from the lung rendering a reproducible, clear and strong signal in sync with the cardiac cycle,
- The observation based on pilot studies that blowing hard against resistance during recording (something called a Valsalva maneuver), affects the lung signal weakening it and even obliterating it as the pressure rises.
The investigators hypothesis is that since the signal comes from the blood vessels in the lung, the pressure at which the recorded signal disappears during the Valsalva maneuver represents the blood pressure in the lungs.
Read the detailed description
Current methods for noninvasive measurement of pulmonary arterial blood pressure by standard echo-doppler equipment are fraught with uncertainty. So much so that patients being screened and followed for pulmonary arterial hypertension require right heart catheterization. An invasive and uncomfortable and potentially dangerous procedure.
This study is designed to confirm our preliminary observation that there is good correlation between Valsalva maneuver pressure and pulmonary arterial blood pressure.
Sixty patients undergoing right heart catheterization for clinical reasons will be studied.
The study itself is short, about 30 minutes, painless and done with the patient either sitting up in bed or semi-reclining. The probe is positioned over the right chest wall and the patient is requested to successively blow into a mouthpiece at rising pressures, to tolerance.
The results obtained using TPD to asses pulmonary arterial pressure will be compared to the results obtained at catheterization.
This is part of the development phase of the technology.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Transthoracic pulmonary doppler recording
- Keywords
- Pulmonary arterial blood pressure doppler
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic pulmonary doppler recordingProcedure or surgery
A 30 min recording of doppler signals from the right chest wall including measurements while the patient performs Valsalva maneuvers
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaching target enrollment number
Enrollment of 60 valid patients
Measured: 1-2 years
Secondary outcomes (1)
Lack of adverse effects
No adverse effects are expected but since this is a new application of old technolology safety is a possible issue.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2012
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Dragu, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357746
- Sponsor's protocol ID
- DOPO8
- Status last verified
- May 2011
- First submitted
- 17 May 2011
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection, Estimation and Characterization of Pulmonary Blood Pressure by Transthoracic Parametric Doppler (TPD)
- ClinicalTrials.gov ID
- NCT01357746
- Acronym / sponsor ID
- DOPO8
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary arterial blood pressure doppler
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (actual)
- First posted
- 23 May 2011 (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.
This is a non-invasive study using a standard doppler echocardiographic transducer which records signals emanating from the lungs (TPD). These signals are caused by pulsation of blood vessels in the lung tissue.
The innovations in this study are:
- The software processing of the reflected ultra-sound waves from the lung rendering a reproducible, clear and strong signal in sync with the cardiac cycle,
- The observation based on pilot studies that blowing hard against resistance during recording (something called a Valsalva maneuver), affects the lung signal weakening it and even obliterating it as the pressure rises.
The investigators hypothesis is that since the signal comes from the blood vessels in the lung, the pressure at which the recorded signal disappears during the Valsalva maneuver represents the blood pressure in the lungs.
Detailed description
Current methods for noninvasive measurement of pulmonary arterial blood pressure by standard echo-doppler equipment are fraught with uncertainty. So much so that patients being screened and followed for pulmonary arterial hypertension require right heart catheterization. An invasive and uncomfortable and potentially dangerous procedure.
This study is designed to confirm our preliminary observation that there is good correlation between Valsalva maneuver pressure and pulmonary arterial blood pressure.
Sixty patients undergoing right heart catheterization for clinical reasons will be studied.
The study itself is short, about 30 minutes, painless and done with the patient either sitting up in bed or semi-reclining. The probe is positioned over the right chest wall and the patient is requested to successively blow into a mouthpiece at rising pressures, to tolerance.
The results obtained using TPD to asses pulmonary arterial pressure will be compared to the results obtained at catheterization.
This is part of the development phase of the technology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Eligibility
- Age 18 years or older
- Patients who are clinically suspected of having elevated pulmonary blood pressure , due to cardiac or cardio-pulmonary disease preferably any one or more of the conditions listed below, and due to have right heart catheterization as part of the diagnostic work-up:
- Patients with CHF
- Patients with primary pulmonary arterial hypertension
Key exclusion criteria (3 listed)
- Patients unable to cooperate.
- Inability to assume a sitting or supine position
- Patients with severe chest wall deformity
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 |
|---|---|---|
| Transthoracic pulmonary doppler recordingA 30 min recording of doppler signals from the right chest wall including measurements while the patient performs Valsalva maneuvers | Procedure or surgery | – |
Primary outcome
Reaching target enrollment number
Time frame: 1-2 years
Enrollment of 60 valid patients
1 secondary outcome
Lack of adverse effects
Time frame: 1-2 years
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
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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.
Robert Dragu, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transthoracic pulmonary doppler recording in people with Pulmonary Arterial Hypertension, run by Echosense Ltd. at 1 site in Israel.
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 10 inclusion and 3 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 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). 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?
Reaching target enrollment number (time frame: 1-2 years). 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 20 Aug 2013.