A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure

• Sponsor: Lantheus Medical Imaging (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00918866
• Collaborator: (none)
• Enrollment: 32
• Locations: 8
• Arms: 2
• Duration (Months): 5
• Patients Per Site: 4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Heart Disease	Drug: Definity	Phase 4

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

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Pulmonary Arterial Pressure Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.	Drug: Definity; one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight; Other Names: Perflutren Lipid Microsphere
Experimental: Elevated Pulmonary Arterial Pressure Subjects with a PAP of > or = to 35 mmHg.	Drug: Definity; one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight; Other Names: Perflutren Lipid Microsphere

Outcome Measures

Primary Outcome Measures

1. Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose [31-35 minutes minus baseline]

   Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose

Secondary Outcome Measures

1. Immunology Panel- Complement 3A (C3A) [Out to 70 minutes]

   Evaluate the Immunology Panel after the administration of DEFINITY

2. Immunology Panel- Complement 5A(C5A) [Out to 70 minutes]

   Evaluate the Immunology Panel after the administration of DEFINITY

3. Immunology Panel- Interleuken-6 [Out to 70 minutes]

   Evaluate the Immunology Panel after the administration of DEFINITY

4. Immunology Panel- Tryptase [Out to 70 minutes]

   Evaluate the Immunology Panel after the administration of DEFINITY

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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:

1. are not pregnant and have been using an adequate and medically approved method of contraception

2. have a negative urine pregnancy test

• Be able and willing to communicate effectively with study center personnel.

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
2	University of Chicago Medical Center	Chicago	Illinois	United States	60637
3	Methodist Hospital	Saint Louis Park	Minnesota	United States	55426
4	Cardiovascular Consultants	Kansas City	Missouri	United States	64111
5	Holy Name Hospital	Teaneck	New Jersey	United States	07666
6	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
7	Oregon Health and Sciences University	Portland	Oregon	United States	97239
8	The University of Texas Medical Branch at Galveston	Galveston	Texas	United States	77555

Sponsors and Collaborators

• Lantheus Medical Imaging

Investigators

• Study Director: Veronica Lee, MD, Lantheus Medical Imaging

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lantheus Medical Imaging
• ClinicalTrials.gov Identifier: NCT00918866
• Other Study ID Numbers: DMP 115-416
• First Posted: Jun 11, 2009
• Last Update Posted: Nov 24, 2020
• Last Verified: Oct 1, 2011

• Keywords provided by Lantheus Medical Imaging: Phase 4; DEFINITY®; hemodynamics; pulmonary artery pressure
• Additional relevant MeSH terms: Heart Diseases; Pulmonary Heart Disease

Study Results

Participant Flow

Recruitment Details	participants were recruited from hospitals and clinics in the USA between July 2009 and December 2009
Pre-assignment Detail	There were no randomization procedures or other pre-assignment requirements in this study.

Arm/Group Title	Low Pulmonary Arterial Pressure	Elevated Pulmonary Arterial Pressure
Arm/Group Description	Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.	Subjects with a PAP of > or = to 35 mmHg.
Period Title: Overall Study
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Low Pulmonary Arterial Pressure	Elevated Pulmonary Arterial Pressure	Total
Arm/Group Description	Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.	Subjects with a PAP of > or = to 35 mmHg.	Total of all reporting groups
Overall Participants	16	16	32
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.9 (10.8)	57.4 (15.1)	57.2 (12.9)
Sex: Female, Male (Count of Participants)
Female	10 62.5%	7 43.8%	17 53.1%
Male	6 37.5%	9 56.3%	15 46.9%
Pulmonary artery pressure 1 minute pre-dose (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	30.4 (3.38)	50.9 (10.31)	40.7 (12.89)

Outcome Measures

1. Primary Outcome

Title	Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose
Description	Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose
Time Frame	31-35 minutes minus baseline

Outcome Measure Data

Analysis Population Description

Per the protocol

Arm/Group Title	Low Pulmonary Arterial Pressure	Elevated Pulmonary Arterial Pressure
Arm/Group Description	Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.	Subjects with a PAP of > or = to 35 mmHg.
Measure Participants	16	16
Mean (Standard Deviation) [mm Hg]	-1.9 (18.03)	-1.7 (10.25)

2. Secondary Outcome

Title	Immunology Panel- Complement 3A (C3A)
Description	Evaluate the Immunology Panel after the administration of DEFINITY
Time Frame	Out to 70 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Pulmonary Arterial Pressure	Elevated Pulmonary Arterial Pressure
Arm/Group Description	Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.	Subjects with a PAP of > or = to 35 mmHg.
Measure Participants	15	15
Mean (Standard Deviation) [ng/ml]	-45.80 (338.14)	-38.20 (414.86)

3. Secondary Outcome

Title	Immunology Panel- Complement 5A(C5A)
Description	Evaluate the Immunology Panel after the administration of DEFINITY
Time Frame	Out to 70 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Pulmonary Arterial Pressure	Elevated Pulmonary Arterial Pressure
Arm/Group Description	Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.	Subjects with a PAP of > or = to 35 mmHg.
Measure Participants	15	15
Mean (Standard Deviation) [ng/ml]	-0.95 (3.56)	0.78 (4.55)

4. Secondary Outcome

Title	Immunology Panel- Interleuken-6
Description	Evaluate the Immunology Panel after the administration of DEFINITY
Time Frame	Out to 70 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Pulmonary Arterial Pressure	Elevated Pulmonary Arterial Pressure
Arm/Group Description	Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.	Subjects with a PAP of > or = to 35 mmHg.
Measure Participants	14	11
Mean (Standard Deviation) [pg/ml]	0.31 (1.46)	0.15 (2.11)

5. Secondary Outcome

Title	Immunology Panel- Tryptase
Description	Evaluate the Immunology Panel after the administration of DEFINITY
Time Frame	Out to 70 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Pulmonary Arterial Pressure	Elevated Pulmonary Arterial Pressure
Arm/Group Description	Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.	Subjects with a PAP of > or = to 35 mmHg.
Measure Participants	16	14
Mean (Standard Deviation) [ug/ml]	-0.24 (0.82)	-0.01 (1.46)

Adverse Events

Time Frame	Through 32 hours
Arm/Group Title	Low Pulmonary Arterial Pressure		Elevated Pulmonary Arterial Pressure
Arm/Group Description	Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.		Subjects with a PAP of > or = to 35 mmHg.
All Cause Mortality
	Low Pulmonary Arterial Pressure		Elevated Pulmonary Arterial Pressure
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Low Pulmonary Arterial Pressure		Elevated Pulmonary Arterial Pressure
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Low Pulmonary Arterial Pressure		Elevated Pulmonary Arterial Pressure
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/16 (25%)		5/16 (31.3%)
General disorders
Chest Pain	0/16 (0%)	0	1/16 (6.3%)	1
Musculoskeletal and connective tissue disorders
Back Pain	1/16 (6.3%)	1	1/16 (6.3%)	1
Myalgia	2/16 (12.5%)	2	3/16 (18.8%)	3
Neck Pain	0/16 (0%)	0	1/16 (6.3%)	1
Nervous system disorders
Dizziness	1/16 (6.3%)	1	0/16 (0%)	0
Headache	1/16 (6.3%)	1	0/16 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.