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RHINO: Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension

Sponsor
National Jewish Health (Other)
Overall Status
Terminated
CT.gov ID
NCT02220634
Collaborator
Astellas Pharma Inc (Industry)
10
Enrollment
1
Location
1
Arm
33.8
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
May 25, 2017
Actual Study Completion Date :
May 25, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of people [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Hypovolemia

    2. 40% Left main coronary stenosis

    3. Moderate or > valvular stenosis

    4. Pericarditis/pericardial effusions

    5. 70% carotid artery stenosis

    6. Positive urine pregnancy test

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Jewish Health Denver Colorado United States 80206

    Sponsors and Collaborators

    • National Jewish Health
    • Astellas Pharma Inc

    Investigators

    • Principal Investigator: Brett E Fenster, MD, National Jewish Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Jewish Health
    ClinicalTrials.gov Identifier:
    NCT02220634
    Other Study ID Numbers:
    • HS-2820
    First Posted:
    Aug 20, 2014
    Last Update Posted:
    Jan 19, 2021
    Last Verified:
    Jan 1, 2021
    Additional relevant MeSH terms:
    Hypertension, Pulmonary
    Hypertension
    Regadenoson

    Study Results

    No Results Posted as of Jan 19, 2021