Conditions: Heart Failure
Keywords: heart failure hypertension, pulmonary heart failure, right-sided heart-assist devices Heart Transplantation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: no

Brief 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.

Detailed description:
The study will begin once the participant arrives in the cardiothoracic intensive care unit (CTICU) after heart surgery for either heart transplant or LVAD placement. As is standard of care after these types of surgeries, the participant will arrive in the CTICU with a breathing tube already in place, receiving iNO, and connected to a breathing machine. The participant will be receiving relaxing medication in an intravenous line provided by the cardiac anesthesiologist and the CTICU physicians. The participant will be unaware of the study period while the participant is sedated. Data will be collected from the monitor screen connected to the participant's arterial and venous lines, and if placed, LVAD monitor. These data are:

Central venous pressure (CVP) Mean arterial pressure (MAP) Mean pulmonary artery pressure (MPAP) Cardiac Index (CI) Systemic vascular resistance (SVR) Pulmonary vascular resistance (PVR) Right ventricular stroke work index (RVSWI) LVAD Flow LVAD Pulsatility Index (PI)

These data will be collected at five different time periods during the first eight hours after surgery.

1. Time zero. Data will be collected after surgery upon your arrival to the CTICU while receiving iNO.
2. After two hours of iNO treatment data will be collected. iPGI2 will then be combined with the current iNO.
3. After two hours of combined iNO and iPGI2 treatment, data will be collected. iNO will then be stopped.
4. After two hours of iPGI2 treatment data will be collected. iNO will be restarted.
5. After two hours of combined iNO and iPGI2 treatment, data will be collected. The study ends after this data collection time.

Arms:
arm 1: iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)

Interventions: intervention 1: Nitric Oxide intervention 2: Prostacyclin
Intervention descriptions: intervention 1: inhaled nitric oxide intervention 2: inhaled prostacyclin

Protocol document: