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

NCT02734953 | Completed Phase 2 Results

• 1 other identifier: RC6167
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Inhaled nitric oxide; Exercise; 6 minute walk test; CardioMems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in CardioMems Cardiac Output

  2 hours

• Change in 6 Minute Walk Distance (6MWD)

  2 hours

• Change in O2 Saturations

  2 hours

• Change in Modified Borg Dyspnea Scale

  2 hours

• Change in O2 Requirements

  2 hours

Study Arms (1)

Intervention

EXPERIMENTAL

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

Drug: Nitric Oxide

Interventions

Nitric Oxide DRUG

Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test

Also known as: iNOPulse DS

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (3)

• Frantz RP, Benza RL, Kjellstrom 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.

  PMID: 18582809 BACKGROUND

• 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. doi: 10.1161/01.cir.101.17.2066.

  PMID: 10790348 BACKGROUND

• Kjellstrom 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.

  PMID: 24816520 BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Motor Activity

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Results Point of Contact

• Title: Dr Raymond Benza
• Organization: Allegheny Health Network

raymond.benza@ahn.org

412-359-3131

Study Officials

• Raymond L Benza, MD

  West Penn Allegheny Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 26, 2016
• First Posted: April 12, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 24, 2018
• Results First Posted: September 24, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)