Trial Outcomes & Findings for VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB (NCT NCT03122730)
NCT ID: NCT03122730
Last Updated: 2025-07-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
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)
Results posted on
2025-07-31
Participant Flow
Participant milestones
| Measure |
VentaProst
VentaProst (epoprostenol solution for inhalation via custom drug delivery system)
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.
|
|---|---|
|
Part 1: Epoprostenol Then VentaProst
STARTED
|
9
|
|
Part 1: Epoprostenol Then VentaProst
COMPLETED
|
7
|
|
Part 1: Epoprostenol Then VentaProst
NOT COMPLETED
|
2
|
|
Part 2: VentaProst Dose Escalation
STARTED
|
8
|
|
Part 2: VentaProst Dose Escalation
COMPLETED
|
8
|
|
Part 2: VentaProst Dose Escalation
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB
Baseline characteristics by cohort
| Measure |
Part 1: Epoprostenol Then VentaProst
n=7 Participants
an equivalent dose of VentaProst compared to conventionally-administered aerosolized epoprostenol with subsequent dose titration to achieve a clinically significant hemodynamic response
|
Part 2: VentaProst Dose Escalation
n=8 Participants
Dose titration to achieve a clinically significant hemodynamic response.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 8.02 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 9.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight
|
85.6 Kg
STANDARD_DEVIATION 21.11 • n=5 Participants
|
83.6 Kg
STANDARD_DEVIATION 17.57 • n=7 Participants
|
84.5 Kg
STANDARD_DEVIATION 18.61 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Per protocol population (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.
Outcome measures
| Measure |
VentaProst
n=7 Participants
VentaProst (epoprostenol solution for inhalation via custom drug delivery system)
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.
|
|---|---|
|
Identify Equivalent Dose of VentaProst Necessary to Achieve a PD Response Comparable to Standard of Care Treatment (Part I)
|
17 ng/kg/min
|
SECONDARY outcome
Timeframe: 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)Population: Per protocol population (Part II)
Calculate vascular resistance indicators for CI and CO, and PAPi at each dose level. Identify the VP dose where mPAP, VR(CO), VR(CI), CVP are lowest, and CI/CO are highest. Compare in a narrative to the selected VP optimal dose by the Investigator by individual patient.
Outcome measures
| Measure |
VentaProst
n=8 Participants
VentaProst (epoprostenol solution for inhalation via custom drug delivery system)
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.
|
|---|---|
|
Optimal Dose Determination With VP Dose Escalation (Part II)
Optimal VP dose 1
|
6.8 ng/kg/min
|
|
Optimal Dose Determination With VP Dose Escalation (Part II)
Optimal VP dose 2
|
10.2 ng/kg/min
|
|
Optimal Dose Determination With VP Dose Escalation (Part II)
Optimal VP dose 3
|
13.6 ng/kg/min
|
Adverse Events
Part 1: Epoprostenol Then VentaProst
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: VentaProst Dose Escalation
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Epoprostenol Then VentaProst
n=7 participants at risk
an equivalent dose of VentaProst compared to conventionally-administered aerosolized epoprostenol
|
Part 2: VentaProst Dose Escalation
n=8 participants at risk
Dose titration to achieve a clinically significant hemodynamic response.
|
|---|---|---|
|
Cardiac disorders
pulmonary hypertension
|
14.3%
1/7 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
0.00%
0/8 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
|
Vascular disorders
arterial hemorrhage
|
0.00%
0/7 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
25.0%
2/8 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
Other adverse events
| Measure |
Part 1: Epoprostenol Then VentaProst
n=7 participants at risk
an equivalent dose of VentaProst compared to conventionally-administered aerosolized epoprostenol
|
Part 2: VentaProst Dose Escalation
n=8 participants at risk
Dose titration to achieve a clinically significant hemodynamic response.
|
|---|---|---|
|
Blood and lymphatic system disorders
coagulopathy
|
14.3%
1/7 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
0.00%
0/8 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
|
Endocrine disorders
adrenal insufficiency
|
14.3%
1/7 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
0.00%
0/8 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
|
Renal and urinary disorders
acute kidney injury
|
14.3%
1/7 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
0.00%
0/8 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
|
Respiratory, thoracic and mediastinal disorders
acute lung injury
|
14.3%
1/7 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
0.00%
0/8 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
|
Respiratory, thoracic and mediastinal disorders
traumatic hemothorax
|
14.3%
1/7 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
0.00%
0/8 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
|
Vascular disorders
arterial hemorrhage
|
0.00%
0/7 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
12.5%
1/8 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
|
Vascular disorders
hemorrhage
|
0.00%
0/7 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
12.5%
1/8 • Adverse events were collect from post-cardiac surgery (Day 1) through study completion (up to 30 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place