NCT04297241

Nitrate Effect on Exercise Capacitance

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fontan

Interventions

Type	Name	Description
DRUG	Isosorbide Dinitrate	All patients will be given a 6 week titration regimen of study medication. Patients will begin at a 5mg dosage and titrate up to 30mg three times per day if each subsequent dose is tolerated.

Timeline

• Start date: 2019-12-12
• Primary completion: 2020-06-30
• Completion: 2021-05-03
• First posted: 2020-03-05
• Last updated: 2021-09-22
• Results posted: 2021-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study