Pulmonary Heart DiseasePhase 4NCT00918866
A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure
A Phase 4 study testing Definity in people with Pulmonary Heart Disease, run by Lantheus Medical Imaging at 8 sites in United States.
Trial summary
The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Heart Disease
- What is being tested?
- Definity
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2009to Dec 2009
- 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
- Appropriate candidate scheduled to undergo right heart catheterization and measurement of pulmonary artery hemodynamics for clinical reasons
- Be male or female above the age of 18
- Female patients who no longer have child-bearing potential
- Women of Child-Bearing Potential(WOCBP) who:
- are not pregnant and have been using an adequate and medically approved method of contraception
- have a negative urine pregnancy test
- Be able and willing to communicate effectively with study center personnel.
Who cannot join
- Women who are pregnant or lactating
- Known hypersensitivity or contraindication to or greater heart block
- Previous heart transplant
- Known right-to-left shunt (including atrial septal defect)
- Severe pulmonary artery hypertension (i.e., > 75 mmHg
- Current uncontrolled ventricular tachycardia
- Second-degree or greater heart block
- Any contraindications for the use of a right heart catheter
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Cardiovascular Consultants
Kansas City, Missouri, 64111
Oregon Health and Sciences University
Portland, Oregon, 97239
Methodist Hospital
Saint Louis Park, Minnesota, 55426
Holy Name Hospital
Teaneck, New Jersey, 07666
About this study
Official title: A Phase IV, Open-Label Safety Evaluation of the Effect of DEFINITY® on Pulmonary Artery Hemodynamics in Patients With Normal and Increased Pulmonary Artery Pressure
The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.
Read the detailed description
This Phase IV safety study will provide safety data on potential systemic and pulmonary hemodynamic effects caused by the administration of DEFINITY® in patients who are to undergo right heart cardiac catheterization for clinical reasons. Using a right heart catheter for direct measurements of pulmonary artery hemodynamics will allow accurate assessments of potential alterations of the pulmonary vasculature. This will be further investigated by the inclusion of two patient populations, one with a baseline pulmonary artery pressure < 35 mmHg, and one with elevated baseline pulmonary artery pressure. The addition of immune parameter measurements will assess a potential link between systemic and pulmonary alterations and potential immune reactions following DEFINITY® administration.
The inclusion of patients in this study is not based on a required echocardiogram with DEFINITY® administration because patients would be exposed to an unjustifiable risk of invasive right heart catheterization and are unlikely to consent to such a procedure. Therefore, patients undergoing heart catheterization for clinical reasons, or patients who are undergoing pulmonary artery hemodynamic assessments will be enrolled and receive DEFINITY® in this study.
- Conditions
- Pulmonary Heart Disease
- Being tested
- Definity
- Keywords
- Phase 4, DEFINITY®, hemodynamics, pulmonary artery pressure
- Medical subject headings
- Pulmonary Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefinityDrug
Also called Perflutren Lipid Microsphere
one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight
| Study group | Role | What they receive |
|---|---|---|
| Low Pulmonary Arterial Pressure | Experimental | Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg. Receives: Drug: Definity |
| Elevated Pulmonary Arterial Pressure | Experimental | Subjects with a PAP of > or = to 35 mmHg. Receives: Drug: Definity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose
Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose
Measured: 31-35 minutes minus baseline
Secondary outcomes (4)
Immunology Panel- Complement 3A (C3A)
Evaluate the Immunology Panel after the administration of DEFINITY
Measured: Out to 70 minutes
Immunology Panel- Complement 5A(C5A)
Evaluate the Immunology Panel after the administration of DEFINITY
Measured: Out to 70 minutes
Immunology Panel- Interleuken-6
Evaluate the Immunology Panel after the administration of DEFINITY
Measured: Out to 70 minutes
Immunology Panel- Tryptase
Evaluate the Immunology Panel after the administration of DEFINITY
Measured: Out to 70 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
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 Heart DiseaseStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronica Lee, MD, Study director, Lantheus Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918866
- Sponsor's protocol ID
- DMP 115-416
- Status last verified
- Oct 2011
- First submitted
- 4 Jun 2009
- Last updated
- 24 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-Label Safety Evaluation of the Effect of DEFINITY® on Pulmonary Artery Hemodynamics in Patients With Normal and Increased Pulmonary Artery Pressure
- ClinicalTrials.gov ID
- NCT00918866
- Acronym / sponsor ID
- DMP 115-416
- Conditions
- Pulmonary Heart Disease
- Keywords
- Phase 4, DEFINITY®, hemodynamics, pulmonary artery pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Posted 11 Jul 2011
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 clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.
Detailed description
This Phase IV safety study will provide safety data on potential systemic and pulmonary hemodynamic effects caused by the administration of DEFINITY® in patients who are to undergo right heart cardiac catheterization for clinical reasons. Using a right heart catheter for direct measurements of pulmonary artery hemodynamics will allow accurate assessments of potential alterations of the pulmonary vasculature. This will be further investigated by the inclusion of two patient populations, one with a baseline pulmonary artery pressure < 35 mmHg, and one with elevated baseline pulmonary artery pressure. The addition of immune parameter measurements will assess a potential link between systemic and pulmonary alterations and potential immune reactions following DEFINITY® administration.
The inclusion of patients in this study is not based on a required echocardiogram with DEFINITY® administration because patients would be exposed to an unjustifiable risk of invasive right heart catheterization and are unlikely to consent to such a procedure. Therefore, patients undergoing heart catheterization for clinical reasons, or patients who are undergoing pulmonary artery hemodynamic assessments will be enrolled and receive DEFINITY® in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Pulmonary Arterial Pressure | Experimental | Drug: DefinitySubjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg. |
| Elevated Pulmonary Arterial Pressure | Experimental | Drug: DefinitySubjects with a PAP of > or = to 35 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Appropriate candidate scheduled to undergo right heart catheterization and measurement of pulmonary artery hemodynamics for clinical reasons
- Be male or female above the age of 18
- Female patients who no longer have child-bearing potential
- Women of Child-Bearing Potential(WOCBP) who:
- Be able and willing to communicate effectively with study center personnel.
Key exclusion criteria (8 listed)
- Women who are pregnant or lactating
- Known hypersensitivity or contraindication to or greater heart block
- Previous heart transplant
- Known right-to-left shunt (including atrial septal defect)
- Severe pulmonary artery hypertension (i.e., > 75 mmHg
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 |
|---|---|---|
| DefinityAlso: Perflutren Lipid Microsphereone bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight | Drug | Elevated Pulmonary Arterial Pressure, Low Pulmonary Arterial Pressure |
Primary outcome
Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose
Time frame: 31-35 minutes minus baseline
Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose
4 secondary outcomes
Immunology Panel- Complement 3A (C3A)
Time frame: Out to 70 minutes
Immunology Panel- Complement 5A(C5A)
Time frame: Out to 70 minutes
Immunology Panel- Interleuken-6
Time frame: Out to 70 minutes
Immunology Panel- Tryptase
Time frame: Out to 70 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- 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.
Veronica Lee, MD study director
Lantheus Medical Imaging
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Definity in people with Pulmonary Heart Disease, run by Lantheus Medical Imaging at 8 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 7 inclusion and 8 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 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
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 11 Jul 2011). 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?
Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose (time frame: 31-35 minutes minus baseline). 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 Nov 2020.