Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension (RHINO)

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Drug: Regadenoson

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 requires confirmation of elevated pulmonary pressures.. Right heart catheterization (RHC) is a procedure to determine the diagnosis of PH. .

This research study is looking at the effect of intravenous infusion of the medication Regadenoson on pulmonary vasodilator response compared to the inhaled nitric oxide (iNO) response. iNO is the current standard of care practice.

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.

You will be asked to sign this informed consent form. Then, you will undergo right heart catheterization as part of your clinical care. Those who are positive for pulmonary hypertension will then undergo Regadenoson infusion and a inhaled iNO. Prior to the infusion, subjects will be asked if they have had in the last 12 hours any caffeine-containing foods or beverages, caffeine-containing medications such as theophylline 12 hours prior. Vital sign measurements will be taken to measure your heart. For those subjects that have low heart volume they will be given 500 cc of normal saline in their IV. Vital sign measurements will be taken again to make sure your heart volume is in the normal range. The doctor will administer Regadenoson 0.4 mg intravenously and this will cause your heart rate to increase. The doctor will be taking heart measurements 90 seconds, 5 minutes, 10 minutes, and 20 minutes after administration. Approximately 30 minutes after the Regadenoson has been administered you will be given iNO by facemask for 5 minutes.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Regadenoson; Intravenous infusion of the A2A agonist regadenoson has a preferential vasodilator effect on pulmonary vasculature that is comparable to iNO, the current gold standard for pulmonary vasoreactivity studies.	Drug: Regadenoson; Injection for intravenous administration; Other Names: Lexiscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of people	5 years

Collaborators and Investigators

• Sponsor: National Jewish Health
• Collaborators: Astellas Pharma Inc
• Investigators: Principal Investigator: Brett E Fenster, MD, National Jewish Health

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): May 25, 2017
• Study Completion (ACTUAL): May 25, 2017

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: August 18, 2014
• First Posted (ESTIMATE): August 20, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine A2 Receptor Agonists; Regadenoson
• Other Study ID Numbers: HS-2820