Pulmonary HypertensionNCT01839786
Evaluation of Lung Doppler Signals in Pulmonary Hypertension
An observational study of Pulmonary Hypertension, run by Echosense Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether this non-invasive tool could be used in pulmonary hypertension diagnosis and monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Feb 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suspected of PHTN
Who may be able to join
- Prospective arm:
- Man or woman aged over 18.
- With suspicion or diagnosis of pulmonary hypertension.
- Scheduled to undergo right heart catheterization
- Able and willing to give informed consent.
- Retrospective arm:
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- Man or woman aged over 18.
- With diagnosis of pulmonary hypertension confirmed by right heart catheterization in the past.
- Able and willing to give informed consent.
Who cannot join
- Both arms:
- Minor (aged < 18).
- People unable or unwilling to give informed consent.
- Hemodynamically unstable patients.
- Pregnant women.
- Prospective arm only:
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- Patients with contra-indication to right heart catheterization.
- Patients incapable of performing a Valsalva maneuver.
- Patients with recent myocardial infarction, high degree AV block, severe aortic stenosis or glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether this non-invasive tool could be used in pulmonary hypertension diagnosis and monitoring.
Read the detailed description
PROTOCOL SUMMARY
Title: Evaluation of lung Doppler signals (LDS) in pulmonary hypertension (PHTN) Device: SONARA/tek transcranial Doppler (TCD) system Study Objectives: To evaluate the LDS in patients with PHTN that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether these signals can be used in pulmonary hypertension diagnosis and monitoring.
Study Design:
Two study arms:
- Prospective arm to measure LDS during right heart catheterization in patients undergoing the procedure for evaluation of PHTN.
- Retrospective arm to measure LDS in patients in whom previous RHC confirmed the presence of PHTN.
Recruitment target: Prospective arm: 50 patients during 18 months. Retrospective arm: 50 patients during 18 months.
Study Population:
- Patients suspected of PHTN by echocardiogram, who are scheduled to undergo RHC (prospective arm)
- Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm)
Study endpoint:
- Comparison of pulmonary blood pressures at rest, following vasodilator medication and following upper extremities exercise as measured by RHC and by the LDS during the Valsalva maneuver.
- Determining LDS characteristics of PHTN patients
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Doppler, Valsalva
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PHTN patients | 2. Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Find specific features that characterize lung signals of PHTN patients in comparison to control patients
The outcomes will be elaborate by statistical analysis of whole group data
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2017
- Study completionFeb 2017
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
- Other
- Time perspective
- Other
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
- Investigators
- Issahar Ben-Dov, MD, Principal investigator, Sheba Medical center, Pulmonary institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839786
- Sponsor's protocol ID
- DOP14
- Status last verified
- Apr 2013
- First submitted
- 18 Apr 2013
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Doppler Signals in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01839786
- Acronym / sponsor ID
- DOP14
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Doppler, Valsalva
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Study start
- May 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 Apr 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.
The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether this non-invasive tool could be used in pulmonary hypertension diagnosis and monitoring.
Detailed description
PROTOCOL SUMMARY
Title: Evaluation of lung Doppler signals (LDS) in pulmonary hypertension (PHTN) Device: SONARA/tek transcranial Doppler (TCD) system Study Objectives: To evaluate the LDS in patients with PHTN that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether these signals can be used in pulmonary hypertension diagnosis and monitoring.
Study Design:
Two study arms:
- Prospective arm to measure LDS during right heart catheterization in patients undergoing the procedure for evaluation of PHTN.
- Retrospective arm to measure LDS in patients in whom previous RHC confirmed the presence of PHTN.
Recruitment target: Prospective arm: 50 patients during 18 months. Retrospective arm: 50 patients during 18 months.
Study Population:
- Patients suspected of PHTN by echocardiogram, who are scheduled to undergo RHC (prospective arm)
- Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm)
Study endpoint:
- Comparison of pulmonary blood pressures at rest, following vasodilator medication and following upper extremities exercise as measured by RHC and by the LDS during the Valsalva maneuver.
- Determining LDS characteristics of PHTN patients
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PHTN patients | – | –2. Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of PHTN
Key inclusion criteria (9 listed)
- Prospective arm:
- Retrospective arm:
Key exclusion criteria (9 listed)
- Both arms:
- Prospective arm only:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Find specific features that characterize lung signals of PHTN patients in comparison to control patients
Time frame: 18 months
The outcomes will be elaborate by statistical analysis of whole group data
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 21 Mar 2017.
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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.
Issahar Ben-Dov, MD principal investigator
Sheba Medical center, Pulmonary institute
1 site 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 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 9 inclusion and 9 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 21 Mar 2017. 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.
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?
Find specific features that characterize lung signals of PHTN patients in comparison to control patients (time frame: 18 months). 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 21 Mar 2017.