Status:
TERMINATED
Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension
Lead Sponsor:
National Jewish Health
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to see if Regadenoson may offer improved ease of use, single dose administration, and better tolerance for testing for pulmonary hypertension than iNO. You will be screene...
Detailed Description
Pulmonary hypertension (PH) is an increase of blood pressure in the pulmonary vascular system that could cause shortness of breath, dizziness, leg swelling and heart failure. . The diagnosis of PH re...
Eligibility Criteria
Inclusion
- Age 18-75 years old
- Diagnosis of RHC-proven PH
- Mean pulmonary artery pressure (mPAP) \> 25 mmHg
- Pulmonary vascular resistance (PVR) \> 3 woods units
- Pulmonary capillary wedge pressure (PCWP) \< 15 mmHg).
Exclusion
- Second- or third-degree AV block or sinus node dysfunction
- Known hypersensitivity to adenosine or regadenoson
- Systolic blood pressure \< 90mm Hg
- Active bronchospasm
- Autonomic dysfunction as defined by prior diagnosis of:
- Postural Orthostatic Tachycardia Syndrome (POTS)
- Neurocardiogenic Syncope (NCS)
- Neurally Mediated Hypotension (NMH)
- Vasovagal Syncope
- Hypovolemia
- \> 40% Left main coronary stenosis
- Moderate or \> valvular stenosis
- Pericarditis/pericardial effusions
- \> 70% carotid artery stenosis
- Positive urine pregnancy test
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02220634
Start Date
August 1 2014
End Date
May 25 2017
Last Update
January 19 2021
Active Locations (1)
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1
National Jewish Health
Denver, Colorado, United States, 80206