Nitrate Effect on Exercise Capacitance

  • End date
    Dec 31, 2021
  • participants needed
  • sponsor
    Children's Hospital Medical Center, Cincinnati
Updated on 5 February 2021


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.

Condition Fontan
Treatment Isosorbide Dinitrate
Clinical Study IdentifierNCT04297241
SponsorChildren's Hospital Medical Center, Cincinnati
Last Modified on5 February 2021


Yes No Not Sure

Inclusion Criteria

Underlying Fontan physiology
On a stable medication regimen for the past 3 months
Nine years of age or older

Exclusion Criteria

Pregnant or nursing
Prior hospitalization for heart failure in past year
Presence of uncontrolled arrhythmias within the past 6 months
Non-cardiac conditions which significantly limited exercise
Moderate or severe ventricular dysfunction by echocardiogram or cardiac MRI
Currently treated with a phosphodiesterase-5 inhibitor or organic nitrates
Concurrent enrollment in other investigational drug trial
End stage Liver Disease (ESLD)
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