Phase 2
Completed N=9
VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB
Source: ClinicalTrials.gov NCT03122730 ↗Enrolled (actual)
9
Serious AEs
20.0%
Results posted
Jul 2025
Primary outcomePrimary: Identify Equivalent Dose of VentaProst Necessary to Achieve a PD Response Comparable to Standard of Care Treatment (Part I) — 17 ng/kg/min
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Identify Equivalent Dose of VentaProst Necessary to Achieve a PD Response Comparable to Standard of Care Treatment (Part I) |
17 | — |
| SECONDARY Optimal Dose Determination With VP Dose Escalation (Part II) |
6.8; 10.2; 13.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT03122730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.