Status:
COMPLETED
Nitrate Effect on Exercise Capacitance
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Fontan
Eligibility:
All Genders
9+ years
Phase:
PHASE2
Brief 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. Thi...
Eligibility Criteria
Inclusion
- Underlying Fontan physiology
- On a stable medication regimen for the past 3 months
- Nine years of age or older
Exclusion
- 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)
Key Trial Info
Start Date :
December 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04297241
Start Date
December 12 2019
End Date
May 3 2021
Last Update
September 22 2021
Active Locations (1)
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1
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229