Phase 4
Completed N=14
Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement
Source: ClinicalTrials.gov NCT01717209 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Pulmonary Hypertension — 31.4; 29.1; 25.9; 25.4 mmHg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Research study evaluating the individual and combined effects of inhaled nitric oxide (iNO) and inhaled prostacyclin (iPGI2), on the function of the right heart after surgery for either heart transplant or for left ventricular assist device (LVAD) placement. The investigators hope to learn if these two medications, when given together after surgery, improve right heart function by lowering blood vessel pressures in the lungs. The investigators hope to learn if the combined effects of these two medications are better than either medication used alone. Participants were selected as a possible participant in this study because right heart problems are common during and after surgery for heart transplant and for LVAD placement. In addition, iNO is always given during and after these two types of surgeries at Stanford to help improve how the right heart functions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Hypertension |
31.4; 29.1; 25.9; 25.4; 25.4 | — |
| SECONDARY Right Heart Dysfunction |
5.2; 5.0; 4.8; 5.4; 4.9 | — |
| SECONDARY Systemic Vascular Resistance (SVR) |
1193.9; 1169.7; 1070.6; 1132.4; 1145.9 | — |
| SECONDARY Central Venous Pressure (CVP) |
12.7; 12.6; 11.6; 10.1; 10.6 | — |
| SECONDARY Mean Arterial Pressure (MAP) |
86.29; 80.86; 79.00; 79.43; 80.86 | — |
| SECONDARY Heart Rate |
111.1; 112.5; 108.4; 106.0; 104.6 | — |
Eligibility Criteria
Inclusion Criteria
- Adult cardiac surgical patients scheduled to undergo either heart transplantation or LVAD placement
Exclusion Criteria
- Patients with prior documented allergic reactions or intolerance to either nitric oxide or prostacyclin will be excluded. Patients not undergoing heart transplantation or LVAD placement will be excluded.
Data sourced from ClinicalTrials.gov (NCT01717209). 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.