Effect of Inhaled Albuterol in Pulmonary Hypertension
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2019 |
| Start Date: | October 12, 2017 |
| End Date: | March 30, 2020 |
| Contact: | Adam Wanner, MD |
| Email: | awanner@med.miami.edu |
| Phone: | (305)243-3045 |
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
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. If the results support
this premise, they could serve as the basis for a phase 2 trial investigating the potential
for using inhaled long-acting β2-adrenergic agonists as add-on therapy in group 1 PAH.
Echocardiography will be performed before and after administration of inhaled albuterol.
1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator
therapy, inhaled albuterol causes transient pulmonary vasodilation. If the results support
this premise, they could serve as the basis for a phase 2 trial investigating the potential
for using inhaled long-acting β2-adrenergic agonists as add-on therapy in group 1 PAH.
Echocardiography will be performed before and after administration of inhaled albuterol.
The Investigators will use echocardiography to assess the acute pulmonary hemodynamic effect
of albuterol in 6 patients with group 1 PAH documented by right heart catheterization (mean
pulmonary arterial pressure >25mmHg, pulmonary vascular resistance (PVR) > 3 wood/u and
pulmonary wedge pressure <15). The patients will be on regular oral pulmonary vasodilator
therapy. Mean pulmonary arterial pressure (MPAP) and cardiac output will be measured before
and serially for 2 hours after the administration of either 270μg albuterol or placebo by
inhalation using a spacer. PVR will be calculated by using an estimate of left atrial
pressure.
of albuterol in 6 patients with group 1 PAH documented by right heart catheterization (mean
pulmonary arterial pressure >25mmHg, pulmonary vascular resistance (PVR) > 3 wood/u and
pulmonary wedge pressure <15). The patients will be on regular oral pulmonary vasodilator
therapy. Mean pulmonary arterial pressure (MPAP) and cardiac output will be measured before
and serially for 2 hours after the administration of either 270μg albuterol or placebo by
inhalation using a spacer. PVR will be calculated by using an estimate of left atrial
pressure.
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
We found this trial at
1
site
Miami, Florida 33136
Principal Investigator: Adam Wanner, MD
Phone: 305-243-2568
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