Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Effects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734953
• Other study ID #: RC6167
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: August 2018
• Source: Allegheny Singer Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pulmonary hypertension is characterized by an increase in the pressures in the blood supply to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall pulmonary vascular resistance (PVR). In patients who have remodeling of their pulmonary vasculature, PVR will increase with exercise instead of decreasing as it would in normal patients. Based on published evidence, the investigators intend to investigate the effects of inhaled nitric oxide (iNO) on patients undergoing standard exercise techniques who have separately and previously had an implanted pulmonary artery monitoring device (CardioMems by St Jude Medical, Inc.) placed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Males or females age 18 to 80 years with a diagnosis of pulmonary arterial hypertension (WHO Group I pulmonary hypertension).

• Must be able to read and understand English and consent for themselves

• Previously implanted CardioMems continuous PA pressure

• Ambulatory and able to complete 6MWD test.

Exclusion Criteria:

• Pregnant or lactating females; negative pregnancy test as confirmed by evaluation of data from pre-enrolled Risk Evaluation and Mitigation Strategies (REMS) program.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Nitric Oxide
Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test

Locations

Country	Name	City	State
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

Frantz RP, Benza RL, Kjellström B, Bourge RC, Barst RJ, Bennett TD, McGoon MD. Continuous hemodynamic monitoring in patients with pulmonary arterial hypertension. J Heart Lung Transplant. 2008 Jul;27(7):780-8. doi: 10.1016/j.healun.2008.04.009. Epub 2008 Jun 2. — View Citation

Hasuda T, Satoh T, Shimouchi A, Sakamaki F, Kyotani S, Matsumoto T, Goto Y, Nakanishi N. Improvement in exercise capacity with nitric oxide inhalation in patients with precapillary pulmonary hypertension. Circulation. 2000 May 2;101(17):2066-70. — View Citation

Kjellström B, Frantz RP, Benza RL, Bennett T, Bourge RC, McGoon MD. Hemodynamic ranges during daily activities and exercise testing in patients with pulmonary arterial hypertension. J Card Fail. 2014 Jul;20(7):485-91. doi: 10.1016/j.cardfail.2014.04.019. Epub 2014 May 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference between baseline (t=0) and post-intervention (t=2h)	2 hours
Secondary	Change in CardioMems Cardiac Output	Difference between baseline (t=0) and post-intervention (t=2h)	2 hours
Secondary	Change in 6 Minute Walk Distance (6MWD)	Difference (in distance walked between 2 set points over 6 minutes) at baseline (t=0) to post-intervention (t=2h).	2 hours
Secondary	Change in O2 Saturations		2 hours
Secondary	Change in Modified Borg Dyspnea Scale	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).	2 hours
Secondary	Change in O2 Requirements	Number of patients that required more or less oxygen by nasal prongs during the course of the study.	2 hours
Secondary	Change in Mean Arterial Pressure	Difference between baseline (t=0) and post-intervention (t=2h).	2 hours
Secondary	Change in Heart Rate	Difference between baseline (t=0) and post-intervention (t=2h)	2 hours
Secondary	Change in Rate Pressure Product	Difference between baseline (t=0) and post-intervention (t=2h)	2 hours
Secondary	Change in Right Ventricular (RV) Power	Difference between baseline (t=0) and post-intervention (t=2h)	2 hours
Secondary	Change in Stroke Volume	Difference between baseline (t=0) and post-intervention (t=2h)	2 hours
Secondary	Change in RV Stroke Work Index	Difference between baseline (t=0) and post-intervention (t=2h)	2 hours