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

NCT03122730 | Completed Phase 2 Results FDA Drug

• 1 other identifier: APC-VP-CLN-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

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.

Conditions

Pulmonary Hypertension

Keywords

Cardiac surgery; Cardiopulmonary bypass; Epoprostenol

Outcome Measures

Primary Outcomes (1)

• Identify Equivalent Dose of VentaProst Necessary to Achieve a PD Response Comparable to Standard of Care Treatment (Part I)

  The primary goal was to establish the dose of VentaProst necessary to achieve a PD response comparable to the standard of care. The first dose of VentaProst tested, 17 ng/kg/min, achieved the dose equivalency.

  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 Outcomes (1)

• Optimal Dose Determination With VP Dose Escalation (Part II)

  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)

Study Arms (1)

VentaProst

EXPERIMENTAL

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.

Combination Product: VentaProst

Interventions

VentaProst COMBINATION_PRODUCT

epoprostenol for inhalation via custom drug delivery system

VentaProst

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aerogen Pharma Limited: lead

Study Sites (3)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: David Durand, MD
• Organization: Aerogen Pharma

ddurand@aerogenpharma.com

510-928-2111

Study Officials

• Charles Hill, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 21, 2017
• Study Start: August 23, 2017
• Primary Completion: March 1, 2019
• Study Completion: May 30, 2019
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)