Phase 2 N=20 Treatment

Nitrate Effect on Exercise Capacitance

Fontan

Bottom Line

View on ClinicalTrials.gov: NCT04297241 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Aug 2021

Primary outcome: Primary: Number of Participants Who Experience an Adverse Reaction to the Study Medication During the Study Enrollment Period. — 16 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Isosorbide Dinitrate (Drug)
Age: Pediatric, Adult, Older Adult · 9+ yrs
Sex: All
Sponsor: Children's Hospital Medical Center, Cincinnati
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Experience an Adverse Reaction to the Study Medication During the Study Enrollment Period.	16	—
SECONDARY Effect of Isosorbide Dinitrate on Liver Stiffness Levels	2.3; 2.1	—
SECONDARY Effect of Isosorbide Dinitrate on Central Venous Pressure	22.5; 20.6	—
SECONDARY Effect of Isosorbide Dinitrate on Maximal Exercise Capacity VO2 Max	1086.7; 1151.3	—
SECONDARY Effect of Isosorbide Dinitrate on Maximal Exercise Capacity Heart Rate Response	156.6; 164.7	—
SECONDARY Effect of Isosorbide Dinitrate on Maximal Exercise Capacity Respiratory Rate Response	1.17; 1.19	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04297241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.