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

Pulmonary Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122730
• Other study ID #: APC-VP-CLN-001
• Status: Completed
• Phase: Phase 2
• Start date: August 23, 2017
• Est. completion date: May 30, 2019

Study information

• Verified date: May 2019
• Source: Aerogen Pharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 30, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Combination Product:
• VentaProst
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.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Aerogen Pharma Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	Treatment-Emergent Adverse Events (TEAEs)	Monitoring of adverse events, complications, surgeries, transfusions, physical exams, clinical laboratory tests, and ECGs	The incidence of TEAEs will be monitored from post cardiac surgery (Day 1) through study completion (up to 30 days)
Secondary	Effects on pulmonary vascular resistance	Changes in pulmonary vascular resistance	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)
Secondary	Effects on oxygenation status	Changes in arterial oxygen saturation	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)
Secondary	Effects on fraction of inspired oxygen (FiO2)	Changes in fraction of inspired oxygen (FiO2)	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)
Secondary	Effects on cardiovascular medication usage	Changes in the number and type of cardiovascular medications	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)