Trial Outcomes & Findings for Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH (NCT NCT02734953)

NCT ID: NCT02734953

Last Updated: 2018-09-24

Results Overview

Difference between baseline (t=0) and post-intervention (t=2h)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2018-09-24

Participant Flow

Recruitment period: June 1-25, 2016 Recruitment Location: medical clinic

All enrolled participants were included,

Participant milestones

Measure	Intervention Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants
Sex: Female, Male Female	10 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants

PRIMARY outcome

Timeframe: 2 hours

Difference between baseline (t=0) and post-intervention (t=2h)

Outcome measures

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Difference in Ambulatory 6 Minute Walk Distance (6MWD) Pulmonary Artery (PA) Pressures (Systolic, Diastolic, Mean) Between the Post-intervention (iNO+) and Pre-intervention (iNO-) Condition as Measured by the CardioMems Device PA pressure systolic	-4.86 mmHg Interval -22.96 to 9.31
Difference in Ambulatory 6 Minute Walk Distance (6MWD) Pulmonary Artery (PA) Pressures (Systolic, Diastolic, Mean) Between the Post-intervention (iNO+) and Pre-intervention (iNO-) Condition as Measured by the CardioMems Device PA pressure diastolic	-2.40 mmHg Interval -10.54 to 7.8
Difference in Ambulatory 6 Minute Walk Distance (6MWD) Pulmonary Artery (PA) Pressures (Systolic, Diastolic, Mean) Between the Post-intervention (iNO+) and Pre-intervention (iNO-) Condition as Measured by the CardioMems Device PA pressure mean	-3.45 mmHg Interval -14.97 to 9.85

SECONDARY outcome

Timeframe: 2 hours

Difference between baseline (t=0) and post-intervention (t=2h)

Outcome measures

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Change in CardioMems Cardiac Output	0.76 L/min Interval -1.34 to 5.26

SECONDARY outcome

Timeframe: 2 hours

Difference (in distance walked between 2 set points over 6 minutes) at baseline (t=0) to post-intervention (t=2h).

Outcome measures

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Change in 6 Minute Walk Distance (6MWD)	12.6 m Interval -16.0 to 55.0

SECONDARY outcome

Timeframe: 2 hours

Outcome measures

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Change in O2 Saturations	-1 % O2 Sat Interval -3.0 to 2.0

SECONDARY outcome

Timeframe: 2 hours

The Modified Borg Dyspnea scale measures patient's subjective analysis of dyspnea from 0 ("nothing at all") to 10 ("maximal") during the 6MWD test with the highest value recorded and difference calculated between baseline (t=0) and post-intervention (t=2h).

Outcome measures

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Change in Modified Borg Dyspnea Scale	-0.4 units on a scale Interval -2.0 to 1.0

SECONDARY outcome

Timeframe: 2 hours

Number of patients that required more or less oxygen by nasal prongs during the course of the study.

Outcome measures

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Change in O2 Requirements	0 participants

SECONDARY outcome

Timeframe: 2 hours

Difference between baseline (t=0) and post-intervention (t=2h).

Outcome measures

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Change in Mean Arterial Pressure	-7 mmHg Interval -17.0 to -1.0

SECONDARY outcome

Timeframe: 2 hours

Difference between baseline (t=0) and post-intervention (t=2h)

Outcome measures

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Change in Heart Rate	4 bpm Interval -25.0 to 45.0

SECONDARY outcome

Timeframe: 2 hours

Difference between baseline (t=0) and post-intervention (t=2h)

Outcome measures

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Change in Rate Pressure Product	316 mmHg*beat/min Interval -3490.0 to 8900.0

SECONDARY outcome

Timeframe: 2 hours

Difference between baseline (t=0) and post-intervention (t=2h)

Outcome measures

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Change in Right Ventricular (RV) Power	0.00685 J/s Interval -0.15 to 0.241

SECONDARY outcome

Timeframe: 2 hours

Difference between baseline (t=0) and post-intervention (t=2h)

Outcome measures

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Change in Stroke Volume	2.97 mL Interval -20.8 to 28.0

SECONDARY outcome

Timeframe: 2 hours

Difference between baseline (t=0) and post-intervention (t=2h)

Outcome measures

Measure	Intervention n=10 Participants Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr Nitric Oxide: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Change in RV Stroke Work Index	-1.80 g*m/m2 Interval -11.6 to 1.53

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Raymond Benza

Allegheny Health Network

Phone: 412-359-3131

Email: raymond.benza@ahn.org

Results disclosure agreements

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