Nitrate Effect on Exercise Capacitance (NEET)

Cincinnati Children's Hospital Medical Center

Status and phase: Completed; Phase 2

Conditions: Fontan

Treatments: Drug: Isosorbide Dinitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04297241

2018-0020 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Isosorbide Dinitrate

Experimental group

Description:

Each enrolled participant will be on a titrated dosage of isosorbide dinitrate to determine effectiveness on both primary and secondary outcome measures.

Treatment:

Drug: Isosorbide Dinitrate