Nitrate Effect on Exercise Capacitance — NEET  

Fontan Clinical Trial

Official title: Nitrate Effect on Exercise Capacitance and Hemodynamic Profile Prior to Fontan Failure

Status Completed

Clinical Trial Summary

The investigators will investigate the safety and preliminary efficacy of ISDN therapy to reduce venous congestion and improve exercise tolerance in children and adults after the Fontan operation. This will be accomplished by recruiting 15 Fontan physiology patients from the Cincinnati Children's Fontan clinic and University of Kentucky Pediatric Cardiology clinic for the investigation. The investigators will non-invasively measure both central venous pressures at rest and during graded cardiopulmonary exercise testing. In addition the study team will obtain a measurement of liver stiffness before and after a 4-week regimen of ISDN therapy. Patients will be seen twice in clinic, once before and after ISDN therapy, and phone calls will be made to ensure safety, compliance, and make appropriate alterations to medications throughout the study period. Pre- and post-intervention central venous pressure and exercise tolerance will be compared.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Fontan

• NCT number: NCT04297241
• Study type: Interventional
• Source: Children's Hospital Medical Center, Cincinnati
• Status: Completed
• Phase: Phase 2
• Start date: December 12, 2019
• Completion date: May 3, 2021