Pulmonary Arterial HypertensionPhase 4NCT01508780
Combined Use of Angiography, Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral Bosentan
A Phase 4 study testing St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT) and Boston Scientific Intravascular Ultrasound in people with Pulmonary Arterial Hypertension, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
It has been hypothesized that one of the benefits of bosentan relates to pulmonary vascular remodeling. The investigators believe that this study will help document the nature of beneficial changes that occur in patients with Pulmonary Arterial Hypertension (PAH) in response to bosentan therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT) and Boston Scientific Intravascular Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Feb 2014
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- WHO GROUP 1
- AGE 18-75
- Baseline 6-min walk distance (6MWD) between 200 and 450 m
- Diagnosed with pulmonary artery hypertension during right heart catheterization (Mean Pulmonary Artery Pressure > 25mmHg)
- General Exclusion Criteria
- Pregnant or nursing
Show all 13Show fewer
- Acute or chronic illness other than those associated with PAH (collagen vascular disease, human immunodeficiency virus, or anorexigen use)
- Previously received any investigational medications, prostanoids, or phosphodiesterase inhibitors
- eGFR < 60
- Angina
- Syncope
- Failing right ventricle
- Hemoptysis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
It has been hypothesized that one of the benefits of bosentan relates to pulmonary vascular remodeling. The investigators believe that this study will help document the nature of beneficial changes that occur in patients with Pulmonary Arterial Hypertension (PAH) in response to bosentan therapy. In turn, demonstrating that changes in pulmonary vascular structure and function accompany clinical improvement.
Read the detailed description
Subjects will have Optical coherence tomography (OCT) and Intravascular Ultrasound (IVUS) imaging during the right heart catheterization that diagnoses them as having PAH. Subjects will start their bosentan and will be followed by monthly clinic visits for 4 months. At 4 months they will have repeat OCT and IVUS imaging.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT), Boston Scientific Intravascular Ultrasound
- 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.
St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT)Device
All subjects will have OCT and IVUS imaging during their right heart catheterization.
Boston Scientific Intravascular UltrasoundDevice
All subjects will have OCT and IVUS imaging during their right heart catheterization.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Arterial Hypertension, bosentan | Experimental | Subjects include patients being diagnosed with pulmonary arterial hypertension and starting treatment with bosentan. Receives: Device: St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT); Device: Boston Scientific Intravascular Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the measurement of Pulmonary arterial intimal + Medial thickening by OCT pre and post treatment with bosentan at 4 months
Measured: Baseline and 4 months
Secondary outcomes (2)
Change in pulmonary arterial pulsatility by IVUS pre and post treatment with bosentan at 4 months
Measured: Baseline and 4 months
Change in pulmonary arterial pressure/elastic strain index by IVUS pre and post treatment with bosentan at 4 months
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Due to complex study protocol, no patients have been enrolled in the study.
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.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion
- Responsible party
- Principal investigator, Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
- Investigators
- Ik-Kyung Jang, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508780
- Sponsor's protocol ID
- 2011P000916
- Status last verified
- Feb 2014
- First submitted
- 3 Jan 2012
- Last updated
- 13 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of Angiography, Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral Bosentan
- ClinicalTrials.gov ID
- NCT01508780
- Acronym / sponsor ID
- 2011P000916
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to complex study protocol, no patients have been enrolled in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Actelion
- Study start
- May 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Jan 2012 (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.
It has been hypothesized that one of the benefits of bosentan relates to pulmonary vascular remodeling. The investigators believe that this study will help document the nature of beneficial changes that occur in patients with Pulmonary Arterial Hypertension (PAH) in response to bosentan therapy. In turn, demonstrating that changes in pulmonary vascular structure and function accompany clinical improvement.
Detailed description
Subjects will have Optical coherence tomography (OCT) and Intravascular Ultrasound (IVUS) imaging during the right heart catheterization that diagnoses them as having PAH. Subjects will start their bosentan and will be followed by monthly clinic visits for 4 months. At 4 months they will have repeat OCT and IVUS imaging.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Arterial Hypertension, bosentan | Experimental | Device: St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT), Device: Boston Scientific Intravascular UltrasoundSubjects include patients being diagnosed with pulmonary arterial hypertension and starting treatment with bosentan. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- WHO GROUP 1
- AGE 18-75
- Baseline 6-min walk distance (6MWD) between 200 and 450 m
- Diagnosed with pulmonary artery hypertension during right heart catheterization (Mean Pulmonary Artery Pressure > 25mmHg)
- General Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT)All subjects will have OCT and IVUS imaging during their right heart catheterization. | Device | Pulmonary Arterial Hypertension, bosentan |
| Boston Scientific Intravascular UltrasoundAll subjects will have OCT and IVUS imaging during their right heart catheterization. | Device | Pulmonary Arterial Hypertension, bosentan |
Primary outcome
Change in the measurement of Pulmonary arterial intimal + Medial thickening by OCT pre and post treatment with bosentan at 4 months
Time frame: Baseline and 4 months
2 secondary outcomes
Change in pulmonary arterial pulsatility by IVUS pre and post treatment with bosentan at 4 months
Time frame: Baseline and 4 months
Change in pulmonary arterial pressure/elastic strain index by IVUS pre and post treatment with bosentan at 4 months
Time frame: Baseline and 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
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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.
Ik-Kyung Jang, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT) and Boston Scientific Intravascular Ultrasound in people with Pulmonary Arterial Hypertension, run by Massachusetts General Hospital at 1 site 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 13 inclusion and 0 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: withdrawn, as of the sponsor's last update on 13 Feb 2014. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 withdrawn before enrolling participants, so there are no results.
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?
Change in the measurement of Pulmonary arterial intimal + Medial thickening by OCT pre and post treatment with bosentan at 4 months (time frame: Baseline and 4 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 13 Feb 2014.