Clinical trial NCT01717209: Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement
Official title: Combined Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplantation and for Left Ventricular Assist Device Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: heart failure
hypertension, pulmonary
heart failure, right-sided
heart-assist devices
Heart Transplantation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pulmonary Hypertension
timeFrame: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))
Secondary outcomes:
measure: Right Heart Dysfunction
timeFrame: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))
measure: Systemic Vascular Resistance (SVR)
timeFrame: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))
measure: Central Venous Pressure (CVP)
timeFrame: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))
measure: Mean Arterial Pressure (MAP)
timeFrame: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))
measure: Heart Rate
timeFrame: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
name: Andrew J Powers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khan TA, Schnickel G, Ross D, Bastani S, Laks H, Esmailian F, Marelli D, Beygui R, Shemin R, Watson L, Vartapetian I, Ardehali A. A prospective, randomized, crossover pilot study of inhaled nitric oxide versus inhaled prostacyclin in heart transplant and lung transplant recipients. J Thorac Cardiovasc Surg. 2009 Dec;138(6):1417-24. doi: 10.1016/j.jtcvs.2009.04.063.
citation: De Wet CJ, Affleck DG, Jacobsohn E, Avidan MS, Tymkew H, Hill LL, Zanaboni PB, Moazami N, Smith JR. Inhaled prostacyclin is safe, effective, and affordable in patients with pulmonary hypertension, right heart dysfunction, and refractory hypoxemia after cardiothoracic surgery. J Thorac Cardiovasc Surg. 2004 Apr;127(4):1058-67. doi: 10.1016/j.jtcvs.2003.11.035.
citation: Potapov E, Meyer D, Swaminathan M, Ramsay M, El Banayosy A, Diehl C, Veynovich B, Gregoric ID, Kukucka M, Gromann TW, Marczin N, Chittuluru K, Baldassarre JS, Zucker MJ, Hetzer R. Inhaled nitric oxide after left ventricular assist device implantation: a prospective, randomized, double-blind, multicenter, placebo-controlled trial. J Heart Lung Transplant. 2011 Aug;30(8):870-8. doi: 10.1016/j.healun.2011.03.005. Epub 2011 Apr 29.
citation: Antoniou T, Prokakis C, Athanasopoulos G, Thanopoulos A, Rellia P, Zarkalis D, Kogerakis N, Koletsis EN, Bairaktaris A. Inhaled nitric oxide plus iloprost in the setting of post-left assist device right heart dysfunction. Ann Thorac Surg. 2012 Sep;94(3):792-8. doi: 10.1016/j.athoracsur.2012.04.046. Epub 2012 Jun 23.