Inhaled Nitrite in Subjects With Pulmonary Hypertension
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|ClinicalTrials.gov Identifier: NCT01431313|
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : July 24, 2018
This is a single-center, open label phase II study to evaluate the effect of inhaled nitrite delivered in a dose escalation manner on the change in pulmonary vascular resistance (PVR) in subjects with pulmonary hypertension undergoing right heart catheterization.
A total of 50 subjects with a confirmed diagnosis of pulmonary hypertension and meet all inclusion/exclusion criteria will be enrolled in the study which will entail a single right heart catheterization and nebulized nitrite dose of 45mg with one subsequent dosage of 90 mg.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Drug: Inhaled Nitrite||Phase 2|
Screening Visit:Initial screening evaluations including physical examination, medical history, and clinical laboratory assessments will be conducted to determine study eligibilities during a routine clinic visit at the UPMC HVI, CLC or inpatient at UPMC Presbyterian. Subjects who meet the inclusion criteria and none of the exclusion criteria will be entered into the study.
Day 1: This study visit will occur on the same day subjects are scheduled for their clinically indicated right heart catheterization or who volunteer for a research right heart catheterization for this specific study. Subjects on oral background PAH therapy (ETRA or PDE5I) will be instructed to hold their regimen on the day of the study visit.
Subjects will receive nebulized AIR001 doses escalated based upon safety and tolerability. The dose of inhaled nitrite will be delivered via electronic nebulizer. During the study right heart/pulmonary artery hemodynamics will be measured as well as noninvasive systemic blood pressure monitoring. Subjects will be tested for the changes in pulmonary vascular resistance (PVR) using standard clinical protocol hemodynamic recordings of right atrial, right ventricular, and pulmonary artery pressures, in addition to cardiac output at time zero,
3 Day phone follow up
30 Day follow up visit: All subjects enrolled in the study will be followed for 30 days (+/- 5 day window) after completion of the study treatment. A physical exam and clinical labs will be obtained at this visit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose Escalation Study to Evaluate the Effect of Inhaled Nitrite on Cardiopulmonary Hemodynamics in Subjects With Pulmonary Hypertension|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Experimental: Inhaled Nitrite
Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability.
Drug: Inhaled Nitrite
Each patient will receive a starting dose of 45 mg of inhaled nitrite, with one planned subsequent planned dose of 90 mg of inhaled nitrite
Other Name: Sodium Nitrite
- Change in pulmonary vascular resistance [ Time Frame: Time zero, 15, 30, 45 and 60 minutes of nebulization ]
- Time to maximum PVR decrease [ Time Frame: Timelines 15, 30 and 45 minutes of post-nebulization ]
- Repeated measures ANOVA (RM-ANOVA) for change in PVR calculated from the start of nebulization [ Time Frame: Time zero, 15, 30, 45 and 60 minutes post end of nebulization ]
- Change in systemic blood pressure, [ Time Frame: Time zero and throughout entire procedure ]
- Change in SVR, RV systolic (dP/dtmax/IP, PWRmax/EDV, RV EF, TAPSE), RV diastolic function (dP/dtmin, Tau) [ Time Frame: Pre-dose and one hour post last dosage inhalation ]
- Change in pulmonary vascular impedance / Wave Intensity, [ Time Frame: Pre dose and 60 minutes post last dosage inhaled ]
- Change in plasma nitrite concentrations in mixed venous blood [ Time Frame: Pre-dose, 15 minutes post 45mg and 90mg inhalation ]
- Change in pulmonary artery occlusion (capillary) pullback nitrite and plasma cGMP [ Time Frame: Pre-dose, 15 minutes post 45mg and 90mg inhalation ]
- Change in mitochondrial oxygen consumption compared to baseline after each dose of nitrite [ Time Frame: Pre dose, 15 minutes post 45mg and 90mg inhalation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431313
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Marc A. Simon, MD||University of Pittsburgh|