Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension

• Status: Terminated
• Trial end date: 2017-05-25
• Target enrollment: 0
• Participant gender: All

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 screened to make sure Regadenoson is safe for you with a clinical evaluation, blood tests, and an ECG.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Jewish Health
• Collaborator: Astellas Pharma Inc
• Treatments: Regadenoson

Criteria

Inclusion Criteria:

1. Age 18-75 years old

2. 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 Criteria:

1. Second- or third-degree AV block or sinus node dysfunction

2. Known hypersensitivity to adenosine or regadenoson

3. Systolic blood pressure < 90mm Hg

4. Active bronchospasm

5. Autonomic dysfunction as defined by prior diagnosis of:

• Postural Orthostatic Tachycardia Syndrome (POTS)

• Neurocardiogenic Syncope (NCS)

• Neurally Mediated Hypotension (NMH)

• Vasovagal Syncope

6. Hypovolemia

7. > 40% Left main coronary stenosis

8. Moderate or > valvular stenosis

9. Pericarditis/pericardial effusions

10. > 70% carotid artery stenosis

11. Positive urine pregnancy test