NCT02220634

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2017

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

May 6, 2014

Last Update Submit

January 15, 2021

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Number of people

    5 years

Study Arms (1)

Regadenoson

EXPERIMENTAL

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

Interventions

RegadenosonDRUG

Injection for intravenous administration

Also known as: Lexiscan
Regadenoson

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Brett E Fenster, MD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2014

First Posted

August 20, 2014

Study Start

August 1, 2014

Primary Completion

May 25, 2017

Study Completion

May 25, 2017

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

US(1)