Fontan Clinical Trial - Effects of Pulmonary Vasodilation Upon VA Coupling

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01607983
Study type	Interventional
Source	University of California, San Francisco
Contact
Status	Withdrawn
Phase	Phase 3
Start date	June 2012
Completion date	December 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Recruiting	`NCT04992793` - Paediatric Brain Injury Following Cardiac Interventions
Recruiting	`NCT05213598` - Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
Completed	`NCT04136379` - Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
Completed	`NCT04814888` - 3D Airway Model for Pediatric Patients
Recruiting	`NCT04920643` - High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery	N/A
Completed	`NCT05934578` - Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training	N/A
Recruiting	`NCT06041685` - Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia	N/A
Recruiting	`NCT05902013` - Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation	N/A
Not yet recruiting	`NCT05687292` - Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
Not yet recruiting	`NCT05524324` - Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT	N/A
Completed	`NCT02746029` - Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
Completed	`NCT03119090` - Fontan Imaging Biomarkers (FIB) Study
Completed	`NCT02537392` - Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease	N/A
Recruiting	`NCT02258724` - Swiss National Registry of Grown up Congenital Heart Disease Patients
Terminated	`NCT02046135` - Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery	Phase 2
Completed	`NCT01966237` - Milrinone Pharmacokinetics and Acute Kidney Injury
Recruiting	`NCT01184404` - Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery	N/A
Completed	`NCT01548950` - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension	N/A
Completed	`NCT01178710` - Effect of Simvastatin on Cardiac Function	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of Pulmonary Vasodilation Upon VA Coupling in Fontan Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms