VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:4/6/2019
Start Date:August 23, 2017
End Date:April 30, 2019
Contact:Judy Doto, RN
Email:judydoto@aerogenpharma.com
Phone:4847165438

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A Two-Part Pharmacodynamic Study to Compare VentaProst (Epoprostenol Solution for Inhalation Via Custom Drug Delivery System) Dosing to Conventionally Administered Aerosolized Epoprostenol Dosing in Cardiac Surgery Patients

The purpose of the Phase 2a study is to: 1) demonstrate that the estimated VentaProst dose is
safe and equivalent in effect to a dose administered via epoprostenol aerosolization by the
current off-label-use practice; and 2) demonstrate that an optimum effect can be rapidly
obtained with VentaProst titration.

Part I:

This part of the study is designed to demonstrate the dose equivalence between off-label
aerosolized epoprostenol and VentaProst using a patient's hemodynamic parameters.

Part II:

This part of the study is designed to establish a dose response relationship of VentaProst to
hemodynamic effect by dose escalation in patients who have had cardiac surgery with CPB.

Inclusion Criteria:

1. Women and Men 18 to 75 years of age

2. Provide written informed consent

3. Willing and able to comply with all aspects of the protocol

4. For patients in Part I:

1. Undergo cardiac surgery on CPB

2. Clinically require treatment with and receive aerosolized epoprostenol

3. Demonstrate a clinically meaningful hemodynamic response to aerosolized
epoprostenol

5. For patients in Part II:

1. Undergo cardiac surgery with CPB

2. Have perioperative pulmonary hypertension

3. Clinically require treatment with inhaled epoprostenol

Exclusion Criteria:

1. Current smoker (i.e., within the last 30 days)

2. Emergency operative status

3. Upper and/or lower respiratory tract infection within four weeks of screening

4. Contraindication to transesophageal echocardiogram (TEE) including esophageal disease
or unstable cervical spine

5. Renal or severe hepatic impairment

6. Thromboembolic disease treated with anticoagulant therapy

7. Bleeding disorders

8. Significant restrictive or obstructive lung disease

9. History of concurrent malignancy or recurrence of malignancy within two years prior to
Screening

10. History of a diagnosis of drug or alcohol dependency or abuse within approximately the
last three years

11. Recent history of stroke or transient ischemic attack

12. Significantly abnormal laboratory tests at Screening

13. Pregnant or breastfeeding

14. Treatment with an investigational drug, biologic, or device within 30 days

15. Other severe, acute, or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with trial participation or
investigational product administration or may interfere with the interpretation of
trial results and, in the judgment of the Investigator or Sponsor, would make the
patient inappropriate for entry into this trial

16. Any condition where aerosolized epoprostenol is contraindicated

17. Known allergy or sensitivity to epoprostenol, any of its ingredients, or the diluent
We found this trial at
3
sites
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-942-4408
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Phone: 617-636-1334
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Phone: 650-498-6210
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Stanford, CA
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