Effect of Inhaled Albuterol in Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of the present pilot study is to test the hypothesis that in patients with group 1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator therapy, inhaled albuterol causes transient pulmonary vasodilation.

Official Title
-----------------
Effect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept Study

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: Albuterol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A Mean Pulmonary Artery Pressure >25mmHg, Pulmonary Vascular Resistance >3 wood/units and pulmonary arterial wedge pressure <15mmHg, as documented by right heart catheterization within the last 3 years Regular use of oral pulmonary vasodilators Exclusion Criteria: Presence of chronic respiratory disease (as documented by prior lung imaging and pulmonary function tests), cardiovascular disease (as documented by prior echocardiography and/or left heart catheterization), thromboembolic PAH (as documented by pulmonary angiography) women of childbearing potential who do not use accepted birth- control measures pregnant and breast-feeding women respiratory infection within 4 weeks of testing A systemic systolic arterial BP> 150 and/or diastolic arterial BP>100 on the experiment day A resting O2 saturation of < 90% Current smoking BMI >35 kg/m2 and/or a diagnosis of obstructive sleep apnea Use of inhaled or intravenous pulmonary vasodilators

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albuterol followed by placebo<br>Participants in this group will receive albuterol first followed by Placebo on the next visit | Drug: Albuterol<br>* inhalation of 270μg albuterol through a spacer<br>Drug: Placebo<br>* inhalation of placebo through a spacer<br>|
| Experimental: Placebo followed by albuterol<br>Participants in this group will receive placebo first followed by albuterol on the next visit | Drug: Albuterol<br>* inhalation of 270μg albuterol through a spacer<br>Drug: Placebo<br>* inhalation of placebo through a spacer<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Pulmonary Artery Pressure (MPAP) | Change in MPAP will be measured using echocardiogram | Baseline, up to 30 minutes after inhalation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pulmonary Vascular Resistance (PVR) | Change in PVR will be measured using echocardiogram | Baseline, up to 30 minutes after inhalation |