Heart Failure | Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement
Heart Failure research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Nitric Oxideinhaled nitric oxide
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Combined nitric oxide and prostacycliniNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
Start Date: October 2012
Completed Date: October 2013
Phase: Phase 4
Primary Outcome: Pulmonary Hypertension
Secondary Outcome: Right Heart Dysfunction
Study sponsors, principal investigator, and references
Principal Investigator: Andrew J Powers, MD
Lead Sponsor: Stanford University
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.