Pulmonary HypertensionPhase 4NCT00878878
Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).
A Phase 4 study testing Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) and Dextrose in people with Pulmonary Hypertension, run by GE Healthcare at 1 site in United States.
Trial summary
The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization for clinical reasons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) and Dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jul 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Must be already scheduled for left and/or right heart catheterization for clinical reasons.
- Must be in sinus rhythm, without an arrhythmia likely to affect the ability to assess pulmonary hemodynamics by catheterization, as determined by the investigator.
- Women of childbearing potential must be using adequate birth control and have a negative pregnancy test.
Who cannot join
- History of right-to-left, bi-directional, or transient right-to-left cardiac shunts or diagnosed by color flow Doppler echocardiography during screening.
- Hypersensitivity to Optison, perflutren, blood, blood products, or albumin.
- Female subjects who are nursing mothers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 4, Placebo Controlled, Single-blind, Cross-over Safety Study to Evaluate the Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR) as Measured by Right Heart Catheterization
The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization for clinical reasons.
- Conditions
- Pulmonary Hypertension
- Being tested
- Optison (Perflutren Protein-Type A Microspheres Injectable Suspension), Dextrose
- Keywords
- Pulmonary artery systolic pressure (PASP), Pulmonary Vascular Resistance (PVR), Right Heart Catheterization, Pulmonary hemodynamics
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)Drug
Also called Perflutren Protein-Type A Microspheres Injectable Suspension
Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.
Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.
DextroseDrug
Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.
Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Dextrose |
| Arm B | Experimental | Not described Receives: Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed the Change of Pulmonary Artery Systolic Pressure (PASP) Measured by Millimeters of Mercury (mm hg) Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.
Measurement of the Pulmonary artery systolic pressure (PASP) results, which were taken from the subject in millimeters of mercury; a unit of pressure (mm hg), at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.
Measured: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
Observed the Change of Pulmonary Vascular Resistance (PVR) Measured by Wood Units Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.
Measurement of the pulmonary vascular resistance (PVR) results, which was taken from the subject in Wood Units, taken at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.
Measured: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
Secondary outcomes (1)
Recorded Any Adverse Events From the Optison and Control Solution (5% Dextrose) Used in Subjects With Normal and Elevated Pulmonary Artery Systolic Pressure (PASP. This is Per Sequence and Not a Cross-over Study.
Observe subjects with normal pulmonary artery systolic pressure (PASP) and elevated pulmonary artery systolic pressure (PASP) as measured by any adverse events.
The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; 11 subjects that were Normal PASP and 19 subjects that were Elevated PASP.
This is per sequence and not a cross-over study.
Measured: During the injection and catheterization procedure, and for up to 24 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Christopher Jefferds, Study director, ICON Development Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878878
- Sponsor's protocol ID
- GE-191-004
- Status last verified
- Jul 2012
- First submitted
- 8 Apr 2009
- Last updated
- 24 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Placebo Controlled, Single-blind, Cross-over Safety Study to Evaluate the Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR) as Measured by Right Heart Catheterization
- ClinicalTrials.gov ID
- NCT00878878
- Acronym / sponsor ID
- GE-191-004
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary artery systolic pressure (PASP), Pulmonary Vascular Resistance (PVR), Right Heart Catheterization, Pulmonary hemodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- Mar 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Posted 24 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization for clinical reasons.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension), Drug: Dextrose |
| Arm B | Experimental | Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension), Drug: Dextrose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be already scheduled for left and/or right heart catheterization for clinical reasons.
- Must be in sinus rhythm, without an arrhythmia likely to affect the ability to assess pulmonary hemodynamics by catheterization, as determined by the investigator.
- Women of childbearing potential must be using adequate birth control and have a negative pregnancy test.
Key exclusion criteria (3 listed)
- History of right-to-left, bi-directional, or transient right-to-left cardiac shunts or diagnosed by color flow Doppler echocardiography during screening.
- Hypersensitivity to Optison, perflutren, blood, blood products, or albumin.
- Female subjects who are nursing mothers.
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 |
|---|---|---|
| Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)Also: Perflutren Protein-Type A Microspheres Injectable SuspensionArm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose. Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison. | Drug | Arm A, Arm B |
| DextroseArm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose. Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison. | Drug | Arm A, Arm B |
Primary outcome
Observed the Change of Pulmonary Artery Systolic Pressure (PASP) Measured by Millimeters of Mercury (mm hg) Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.
Time frame: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
Measurement of the Pulmonary artery systolic pressure (PASP) results, which were taken from the subject in millimeters of mercury; a unit of pressure (mm hg), at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.
Observed the Change of Pulmonary Vascular Resistance (PVR) Measured by Wood Units Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.
Time frame: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
Measurement of the pulmonary vascular resistance (PVR) results, which was taken from the subject in Wood Units, taken at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.
1 secondary outcome
Recorded Any Adverse Events From the Optison and Control Solution (5% Dextrose) Used in Subjects With Normal and Elevated Pulmonary Artery Systolic Pressure (PASP. This is Per Sequence and Not a Cross-over Study.
Time frame: During the injection and catheterization procedure, and for up to 24 hours post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Christopher Jefferds study director
ICON Development Solutions
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 Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) and Dextrose in people with Pulmonary Hypertension, run by GE Healthcare 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 3 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: finished, as of the sponsor's last update on 24 Aug 2012. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Observed the Change of Pulmonary Artery Systolic Pressure (PASP) Measured by Millimeters of Mercury (mm hg) Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study. (time frame: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration). The study lists 2 primary outcomes in all. 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 24 Aug 2012.