Effects of Pulmonary Vasodilation Upon VA Coupling in Fontan Patients

This study is currently recruiting participants.
Verified January 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
Jeffery Meadows, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01607983
First received: May 24, 2012
Last updated: January 15, 2014
Last verified: January 2014

May 24, 2012
January 15, 2014
June 2012
December 2014   (final data collection date for primary outcome measure)
Effective arterial elastance (Ea) [ Time Frame: Acute, approximately 10-15 minutes ] [ Designated as safety issue: No ]
Patients will undergo hemodynamic evaluation while receiving inhaled nitric oxide. After the measurements are made the nitric oxide will be discontinued. The primary outcome is the change in effective arterial elastance, a value obtained from ventricular pressure-volume assessment, before and while receiving nitric oxide.
Same as current
Complete list of historical versions of study NCT01607983 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Pulmonary Vasodilation Upon VA Coupling in Fontan Patients
The Effect of Selective Pulmonary Vasodilation on Ventricular Afterload and Ventricular-arterial Coupling in Patients With Fontan Physiology and Validation of Echocardiographic Measures of Systolic and Diastolic Function.

The study involves documenting the effects of inhaled nitric oxide upon ventricular-arterial coupling in patients with congenital heart disease and passive pulmonary blood flow. Consenting patients undergoing a clinically-indicated cardiac catheterization will be given inhaled nitric oxide for 10 minutes while intraventricular pressure-volume analysis will be make via conduction catheters.

Patients with complex congenital heart disease and single ventricle physiology typically undergo a staged surgical palliation to a situation where the single ventricle is recruited as the systemic pumping chamber and some (following a Glenn surgery) or all (following a Fontan surgery) systemic venous return flows passively to the lungs. While this physiology eliminates ventricular volume loading and normalizes systemic arterial oxygen saturations, there remain a number of physiologic burdens that limit functional capacity and life expectancy. Evidence suggests that this surgical imposition of the systemic and pulmonary vascular beds in series results in ventricular loading conditions that adversely affect ventricular function. At present, there exist limited means by which to mitigate these burdens, however, new therapies directed at reducing total pulmonary resistance may favorably affect patients with this physiology by reducing systemic venous pressures and improving both ventricular preload and afterload. One such therapy is inhaled nitric oxide (iNO), which is a selective pulmonary vasodilator that has been shown to reduce total pulmonary resistance and improve systemic venous pressures in this patient population. However limited data exist regarding the affects of pulmonary vasodilators like iNO on ventricular loading and ventricular-arterial coupling. This study proposes to assess the effects of pulmonary vasodilator therapy upon ventricular loading and ventricular-arterial coupling in single ventricle patients with passive pulmonary blood flow presenting for elective cardiac catheterization. The study components include obtaining routine (they would be obtained as a part of the clinically-indicated catheterization) hemodynamic measurements with hi-fidelity catheters rather than standard fluid-filled catheters, as well as simultaneous additional measurements with the same catheters at rest and during administration of iNO.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congenital Heart Disease
  • Fontan
Drug: inhaled nitric oxide
20 parts per millon (ppm) of inhaled nitric oxide
Experimental: inhaled nitric oxide
Intervention: Drug: inhaled nitric oxide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All consecutive patients with single ventricle hearts having passive pulmonary blood flow presenting to the cardiac catheterization laboratory for clinically indicated cardiac catheterization.

Exclusion Criteria:

  • Patients with coarctation of the aorta or known bilateral femoral arterial obstruction
  • Patients with known severe systemic venous/Fontan obstruction
  • Patients already receiving sildenafil or other vasodilator therapy
Both
4 Years to 60 Years
No
Contact: Jeffery Meadows, MD 4154764904 jeffery.meadows@ucsf.edu
United States
 
NCT01607983
11-06070
No
Jeffery Meadows, University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Jeffery Meadows, MD University of California, San Francisco
University of California, San Francisco
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP