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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03122730
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Aerogen Pharma Limited
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Charles Hill, MD
Principal Investigator Affiliation	Stanford University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University Medical Center, Stanford, California

Status

Recruiting

Address

Stanford University Medical Center

Stanford, California, 94305

Site Contact

Valerie Ojha, RN

vojha@stanford.edu

650-498-6210

Rush University Medical Center, Chicago, Illinois

Status