Back to resultsVentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VentaProst
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Cardiac surgery, Cardiopulmonary bypass, Epoprostenol
Eligibility Criteria
Inclusion Criteria:
- Women and Men 18 to 75 years of age
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
For patients in Part I:
- Undergo cardiac surgery on CPB
- Clinically require treatment with and receive aerosolized epoprostenol
- Demonstrate a clinically meaningful hemodynamic response to aerosolized epoprostenol
For patients in Part II:
- Undergo cardiac surgery with CPB
- Have perioperative pulmonary hypertension
- Clinically require treatment with inhaled epoprostenol
Exclusion Criteria:
- Current smoker (i.e., within the last 30 days)
- Emergency operative status
- Upper and/or lower respiratory tract infection within four weeks of screening
- Contraindication to transesophageal echocardiogram (TEE) including esophageal disease or unstable cervical spine
- Renal or severe hepatic impairment
- Thromboembolic disease treated with anticoagulant therapy
- Bleeding disorders
- Significant restrictive or obstructive lung disease
- History of concurrent malignancy or recurrence of malignancy within two years prior to Screening
- History of a diagnosis of drug or alcohol dependency or abuse within approximately the last three years
- Recent history of stroke or transient ischemic attack
- Significantly abnormal laboratory tests at Screening
- Pregnant or breastfeeding
- Treatment with an investigational drug, biologic, or device within 30 days
- 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
- Any condition where aerosolized epoprostenol is contraindicated
- Known allergy or sensitivity to epoprostenol, any of its ingredients, or the diluent
Sites / Locations
- Stanford University Medical Center
- Rush University Medical Center
- Tufts Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VentaProst
Arm Description
VentaProst (epoprostenol solution for inhalation via custom drug delivery system)
Outcomes
Primary Outcome Measures
Determination of the equivalent dose of VentaProst necessary to achieve a pharmacodynamic response that is comparable to Standard of Care
Improvement in pharmacodynamic parameters (based on changes in hemodynamic parameters, indices of oxygenation, and ventilator support)
Secondary Outcome Measures
Treatment-Emergent Adverse Events (TEAEs)
Monitoring of adverse events, complications, surgeries, transfusions, physical exams, clinical laboratory tests, and ECGs
Effects on pulmonary vascular resistance
Changes in pulmonary vascular resistance
Effects on oxygenation status
Changes in arterial oxygen saturation
Effects on fraction of inspired oxygen (FiO2)
Changes in fraction of inspired oxygen (FiO2)
Effects on cardiovascular medication usage
Changes in the number and type of cardiovascular medications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03122730
Brief Title
VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerogen Pharma Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Cardiac surgery, Cardiopulmonary bypass, Epoprostenol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VentaProst
Arm Type
Experimental
Arm Description
VentaProst (epoprostenol solution for inhalation via custom drug delivery system)
Intervention Type
Combination Product
Intervention Name(s)
VentaProst
Other Intervention Name(s)
epoprostenol for inhalation via custom drug delivery system
Intervention Description
Part I - an equivalent dose of VentaProst compared to conventionally-administered aerosolized epoprostenol with subsequent dose titration to achieve a clinically significant hemodynamic response Part II - Dose titration to achieve a clinically significant hemodynamic response.
Primary Outcome Measure Information:
Title
Determination of the equivalent dose of VentaProst necessary to achieve a pharmacodynamic response that is comparable to Standard of Care
Description
Improvement in pharmacodynamic parameters (based on changes in hemodynamic parameters, indices of oxygenation, and ventilator support)
Time Frame
Pharmacodynamic changes will be measured during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days)
Secondary Outcome Measure Information:
Title
Treatment-Emergent Adverse Events (TEAEs)
Description
Monitoring of adverse events, complications, surgeries, transfusions, physical exams, clinical laboratory tests, and ECGs
Time Frame
The incidence of TEAEs will be monitored from post cardiac surgery (Day 1) through study completion (up to 30 days)
Title
Effects on pulmonary vascular resistance
Description
Changes in pulmonary vascular resistance
Time Frame
Changes in pulmonary vascular resistance will be measured prior to surgery (Day 1), during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days)
Title
Effects on oxygenation status
Description
Changes in arterial oxygen saturation
Time Frame
Changes in arterial oxygen saturation will be measured prior to surgery (Day 1), during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days)
Title
Effects on fraction of inspired oxygen (FiO2)
Description
Changes in fraction of inspired oxygen (FiO2)
Time Frame
Changes in FiO2 will be measured prior to surgery (Day 1), during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days)
Title
Effects on cardiovascular medication usage
Description
Changes in the number and type of cardiovascular medications
Time Frame
Changes in cardiovascular medication usage will be measured prior to surgery (Day 1), during surgery (Day 1), post-surgery (Day 1), and from start of treatment (Day 1) through study completion (up to 30 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women and Men 18 to 75 years of age
Provide written informed consent
Willing and able to comply with all aspects of the protocol
For patients in Part I:
Undergo cardiac surgery on CPB
Clinically require treatment with and receive aerosolized epoprostenol
Demonstrate a clinically meaningful hemodynamic response to aerosolized epoprostenol
For patients in Part II:
Undergo cardiac surgery with CPB
Have perioperative pulmonary hypertension
Clinically require treatment with inhaled epoprostenol
Exclusion Criteria:
Current smoker (i.e., within the last 30 days)
Emergency operative status
Upper and/or lower respiratory tract infection within four weeks of screening
Contraindication to transesophageal echocardiogram (TEE) including esophageal disease or unstable cervical spine
Renal or severe hepatic impairment
Thromboembolic disease treated with anticoagulant therapy
Bleeding disorders
Significant restrictive or obstructive lung disease
History of concurrent malignancy or recurrence of malignancy within two years prior to Screening
History of a diagnosis of drug or alcohol dependency or abuse within approximately the last three years
Recent history of stroke or transient ischemic attack
Significantly abnormal laboratory tests at Screening
Pregnant or breastfeeding
Treatment with an investigational drug, biologic, or device within 30 days
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
Any condition where aerosolized epoprostenol is contraindicated
Known allergy or sensitivity to epoprostenol, any of its ingredients, or the diluent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Hill, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB
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