Trial Outcomes & Findings for A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure (NCT NCT00918866)

NCT ID: NCT00918866

Last Updated: 2020-11-24

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 32 participants
• Primary outcome timeframe: 31-35 minutes minus baseline
• Results posted on: 2020-11-24

Participant Flow

participants were recruited from hospitals and clinics in the USA between July 2009 and December 2009

There were no randomization procedures or other pre-assignment requirements in this study.

Participant milestones

Measure	Low Pulmonary Arterial Pressure Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg.	Elevated Pulmonary Arterial Pressure Subjects with a PAP of \> or = to 35 mmHg.
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Low Pulmonary Arterial Pressure n=16 Participants Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg.	Elevated Pulmonary Arterial Pressure n=16 Participants Subjects with a PAP of \> or = to 35 mmHg.	Total n=32 Participants Total of all reporting groups
Age, Continuous	56.9 years STANDARD_DEVIATION 10.8 • n=5 Participants	57.4 years STANDARD_DEVIATION 15.1 • n=7 Participants	57.2 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Pulmonary artery pressure 1 minute pre-dose	30.4 mm Hg STANDARD_DEVIATION 3.38 • n=5 Participants	50.9 mm Hg STANDARD_DEVIATION 10.31 • n=7 Participants	40.7 mm Hg STANDARD_DEVIATION 12.89 • n=5 Participants

PRIMARY outcome

Timeframe: 31-35 minutes minus baseline

Population: Per the protocol

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

Outcome measures

Measure	Low Pulmonary Arterial Pressure n=16 Participants Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg.	Elevated Pulmonary Arterial Pressure n=16 Participants Subjects with a PAP of \> or = to 35 mmHg.
Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose	-1.9 mm Hg Standard Deviation 18.03	-1.7 mm Hg Standard Deviation 10.25

SECONDARY outcome

Timeframe: Out to 70 minutes

Evaluate the Immunology Panel after the administration of DEFINITY

Outcome measures

Measure	Low Pulmonary Arterial Pressure n=15 Participants Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg.	Elevated Pulmonary Arterial Pressure n=15 Participants Subjects with a PAP of \> or = to 35 mmHg.
Immunology Panel- Complement 3A (C3A)	-45.80 ng/ml Standard Deviation 338.14	-38.20 ng/ml Standard Deviation 414.86

SECONDARY outcome

Timeframe: Out to 70 minutes

Evaluate the Immunology Panel after the administration of DEFINITY

Outcome measures

Measure	Low Pulmonary Arterial Pressure n=15 Participants Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg.	Elevated Pulmonary Arterial Pressure n=15 Participants Subjects with a PAP of \> or = to 35 mmHg.
Immunology Panel- Complement 5A(C5A)	-0.95 ng/ml Standard Deviation 3.56	0.78 ng/ml Standard Deviation 4.55

SECONDARY outcome

Timeframe: Out to 70 minutes

Evaluate the Immunology Panel after the administration of DEFINITY

Outcome measures

Measure	Low Pulmonary Arterial Pressure n=14 Participants Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg.	Elevated Pulmonary Arterial Pressure n=11 Participants Subjects with a PAP of \> or = to 35 mmHg.
Immunology Panel- Interleuken-6	0.31 pg/ml Standard Deviation 1.46	0.15 pg/ml Standard Deviation 2.11

SECONDARY outcome

Timeframe: Out to 70 minutes

Evaluate the Immunology Panel after the administration of DEFINITY

Outcome measures

Measure	Low Pulmonary Arterial Pressure n=16 Participants Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg.	Elevated Pulmonary Arterial Pressure n=14 Participants Subjects with a PAP of \> or = to 35 mmHg.
Immunology Panel- Tryptase	-0.24 ug/ml Standard Deviation 0.82	-0.01 ug/ml Standard Deviation 1.46

Adverse Events

Low Pulmonary Arterial Pressure

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Elevated Pulmonary Arterial Pressure

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Low Pulmonary Arterial Pressure n=16 participants at risk Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg.	Elevated Pulmonary Arterial Pressure n=16 participants at risk Subjects with a PAP of \> or = to 35 mmHg.
General disorders Chest Pain	0.00% 0/16 • Through 32 hours	6.2% 1/16 • Number of events 1 • Through 32 hours
Musculoskeletal and connective tissue disorders Back Pain	6.2% 1/16 • Number of events 1 • Through 32 hours	6.2% 1/16 • Number of events 1 • Through 32 hours
Musculoskeletal and connective tissue disorders Myalgia	12.5% 2/16 • Number of events 2 • Through 32 hours	18.8% 3/16 • Number of events 3 • Through 32 hours
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/16 • Through 32 hours	6.2% 1/16 • Number of events 1 • Through 32 hours
Nervous system disorders Dizziness	6.2% 1/16 • Number of events 1 • Through 32 hours	0.00% 0/16 • Through 32 hours
Nervous system disorders Headache	6.2% 1/16 • Number of events 1 • Through 32 hours	0.00% 0/16 • Through 32 hours

Additional Information

Dana Washburn, M.D.

Lantheus Medical Imaging

Phone: 978-671-8686

Email: dana.washburn@lantheus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place