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Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement

NCT ID: NCT01717209

Last Updated: 2017-10-09

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combined nitric oxide and prostacyclin

iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)

Group Type EXPERIMENTAL

Nitric Oxide

Intervention Type DRUG

inhaled nitric oxide

Prostacyclin

Intervention Type DRUG

inhaled prostacyclin

Interventions

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Nitric Oxide

inhaled nitric oxide

Intervention Type DRUG

Prostacyclin

inhaled prostacyclin

Intervention Type DRUG

Other Intervention Names

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INOmax inhaled flolan epoprostenol inhaled PGI2

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Charles Hill

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew J Powers, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Stanford Hospital and Clinics

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19931670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15052203 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21530317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22727248 (View on PubMed)

Other Identifiers

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25471

Identifier Type: -

Identifier Source: org_study_id