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Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension (RHINO)

Primary Purpose

Pulmonary Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regadenoson
Sponsored by
National Jewish Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Jewish Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Regadenoson

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of people

Secondary Outcome Measures

Full Information

First Posted
May 6, 2014
Last Updated
January 15, 2021
Sponsor
National Jewish Health
Collaborators
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02220634
Brief Title
Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension
Acronym
RHINO
Official Title
Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
PI left National Jewish Health
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 25, 2017 (Actual)
Study Completion Date
May 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Jewish Health
Collaborators
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regadenoson
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Regadenoson
Other Intervention Name(s)
Lexiscan
Intervention Description
Injection for intravenous administration
Primary Outcome Measure Information:
Title
Number of people
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett E Fenster, MD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension

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