Trial record 10 of 53 for:    Open Studies | "heart transplantation"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Andrew J. Powers, Stanford University
ClinicalTrials.gov Identifier:
NCT01717209
First received: October 26, 2012
Last updated: October 29, 2012
Last verified: October 2012
  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:


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.

  1. Time zero. Data will be collected after surgery upon your arrival to the CTICU while receiving iNO.
  2. After two hours data will be collected. iPGI2 will then be combined with the current iNO.
  3. After two hours of combined iNO and iPGI2, data will be collected. iNO will then be stopped.
  4. Data will be collected after two hours of solo iPGI2 therapy. iNO will be restarted.
  5. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Gasotransmitters
Protective Agents
Antihypertensive Agents
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on August 28, 2014