Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the maximum safe dose and duration of regadenoson (Lexiscan) that can be given to people who are having a lung transplant. Regadenoson will be given as a continuous IV infusion. All participants in the study will receive a regadenoson infusion beginning in the operating room during the lung transplant procedure. Participants will be assigned a certain dose of regadenoson to be given over a 12 or 24 hour period.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christine Lau, MD
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Adenosine; Regadenoson

Criteria

Inclusion Criteria:

• Subjects must be undergoing a bilateral lung transplantation for end-stage lung disease and thus meet all criteria to be listed

• Male or female subject, 18 -75 years of age

• Subjects must sign a study specific informed consent prior to study entry

• Subjects must meet all of the following laboratory values:

1. hemoglobin ≥ 6 g/dL,

2. platelets > 75,000/mcL,

3. aspartate aminotransferase (AST/SGOT)/ alanine aminotransferase (ALT /SGPT) < 2.5 X institutional upper limit of normal,

4. serum creatinine < 1.5 mg/dL,

5. INR < 1.5, PTT < 40 seconds

Exclusion Criteria:

• Subject requires preoperative extracorporeal membrane oxygenation (ECMO)

• Subject has second degree (Mobitz type I or II) or third-degree AV block or sinus node dysfunction

• Subject has history of a bleeding diathesis

• Subject has a history of clinically overt stroke within the past 3 years

• Subject has a history of severe hypertension not adequately controlled with anti-hypertensive medications (Systolic blood pressure ≥ 200 mmHg and/or Diastolic blood pressure ≥ 110 mmHg)

• Subjects who are receiving chronic anti-coagulation or anti-platelet therapy that would preclude surgery (prophylactic aspirin is acceptable)

• Subjects with a history of metastatic cancer

• Subjects with a history of seizure disorder

• Subjects who are receiving or have received within 30 days any other investigational agents

• Subjects who have received theophylline or aminophylline within 12 hours of study dosing