Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement - Full Text View

Purpose

Research study evaluating the individual and combined effects of inhaled medications, nitric oxide and prostacyclin, 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, the inhaled medication, nitric oxide, is always given during and after these two types of surgeries at Stanford to help improve how the right heart functions.

Condition	Intervention	Phase
Heart Failure	Drug: Nitric Oxide Drug: Prostacyclin	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Combined Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplantation and for Left Ventricular Assist Device Placement

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Heart Surgery Heart Transplantation High Blood Pressure Pulmonary Hypertension

Drug Information available for: Nitric oxide Epoprostenol Epoprostenol sodium

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Pulmonary Hypertension [ Time Frame: Eight Hours after cardiac surgery ] [ Designated as safety issue: No ]
Pulmonary hypertension is common during and after cardiac surgery for heart transplant and for LVAD placement. Pulmonary hypertension is a risk factor for right heart dysfunction after these types of surgeries while the patient is in the intensive care unit.

Secondary Outcome Measures:

Right heart dysfunction [ Time Frame: Eight Hours after cardiac surgery ] [ Designated as safety issue: No ]
Right heart dysfunction is common after cardiac surgery for heart transplant and for LVAD placement.

Estimated Enrollment:	20
Study Start Date:	October 2012
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Combined nitric oxide and prostacyclin combined inhaled nitric oxide 20 ppm continuously and inhaled prostacyclin 0.05 micrograms/kg/min continuously for 2 hours duration	Drug: Nitric Oxide inhaled nitric oxide Other Name: INOmax Drug: Prostacyclin inhaled prostacyclin Other Names: inhaled flolan epoprostenol inhaled PGI2

Detailed Description:

The study will begin once the participant arrives in the 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'sarterial 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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult cardiac surgical patients scheduled to undergo either heart transplantation or left ventricular assist device (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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717209

Contacts

Contact: Andrew J Powers, MD	650-723-2300	apowers@stanford.edu
Contact: Charles Hill, MD	(650) 725-1930	chill1@stanford.edu

Locations

United States, California
Stanford Hospital and Clinics	Recruiting
Stanford, California, United States, 94305
Contact: Andrew J Powers, MD 734-751-5949
Principal Investigator: Andrew J Powers, MD

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Andrew J Powers, MD

More Information

Publications:

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.

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.

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. Epub 2011 Apr 29.

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.

Responsible Party:	Andrew J. Powers, Cardiac Anesthesia Fellow, Stanford University
ClinicalTrials.gov Identifier:	NCT01717209 History of Changes
Other Study ID Numbers:	25471
Study First Received:	October 26, 2012
Last Updated:	October 29, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Stanford University:

heart failure
hypertension, pulmonary
heart failure, right-sided
heart-assist devices
Heart Transplantation

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases
Nitric Oxide
Epoprostenol
Tezosentan
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 16, 2013