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

NCT ID: NCT03122730

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-23
• Study Completion Date: 2019-05-30

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.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VentaProst

VentaProst (epoprostenol solution for inhalation via custom drug delivery system)

In Part 1, subjects were treated with a commercial aerosolized epoprostenol and then removed from that treatment. VentaProst was started and titrated to a dose equivalence to maintain at least 90% of hemodynamic response seen with the commerical product.

In Part 2, subjects were treated with VentaProst only.

Group Type: EXPERIMENTAL

VentaProst

Intervention Type: COMBINATION_PRODUCT

epoprostenol for inhalation via custom drug delivery system

Interventions

VentaProst

epoprostenol for inhalation via custom drug delivery system

Intervention Type: COMBINATION_PRODUCT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerogen Pharma Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Hill, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Medical Center

Stanford, California, United States

Rush University Medical Center

Chicago, Illinois, United States

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

APC-VP-CLN-001

Identifier Type: -

Identifier Source: org_study_id