Nitrate Effect on Exercise Capacitance
NEET
1 other identifier
interventional
20
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2019
CompletedFirst Submitted
Initial submission to the registry
February 5, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2021
CompletedResults Posted
Study results publicly available
August 25, 2021
CompletedSeptember 22, 2021
July 1, 2021
7 months
February 5, 2020
July 9, 2021
August 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Experience an Adverse Reaction to the Study Medication During the Study Enrollment Period.
Potential adverse side effects of study medication (isosorbide dinitrate) will be monitored throughout study period. Study medication will be titrated to a maximal dose of 30mg dependent on the patient tolerance. Patient tolerance is defined by frequency of known risk factors to the study medication (headaches, hypotension, and syncope).
Baseline and 6 weeks
Secondary Outcomes (5)
Effect of Isosorbide Dinitrate on Liver Stiffness Levels
Baseline and 6 weeks
Effect of Isosorbide Dinitrate on Central Venous Pressure
Baseline and 6 weeks
Effect of Isosorbide Dinitrate on Maximal Exercise Capacity VO2 Max
Baseline and 6 weeks
Effect of Isosorbide Dinitrate on Maximal Exercise Capacity Heart Rate Response
Baseline and 6 weeks
Effect of Isosorbide Dinitrate on Maximal Exercise Capacity Respiratory Rate Response
Baseline and 6 weeks
Study Arms (1)
Isosorbide Dinitrate
EXPERIMENTALEach enrolled participant will be on a titrated dosage of isosorbide dinitrate to determine effectiveness on both primary and secondary outcome measures.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Underlying Fontan physiology
- On a stable medication regimen for the past 3 months
- Nine years of age or older
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Related Publications (1)
Bigelow AM, Riggs KW, Morales DLS, Opotowsky AR, Lubert AM, Dillman JR, Veldtman GR, Heydarian HC, Trout AT, Cooper DS, Goldstein SL, Chin C, Palermo JJ, Ollberding NJ, Mays WA, Alsaied T. Isosorbide DiNitrate Effect on Hemodynamic Profile, Liver Stiffness, and Exercise Tolerance in Fontan Circulation (The NEET Clinical Trial). Pediatr Cardiol. 2024 Oct;45(7):1389-1397. doi: 10.1007/s00246-023-03156-3. Epub 2023 Apr 21.
PMID: 37084132DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mary Banks
- Organization
- Cincinnati Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2020
First Posted
March 5, 2020
Study Start
December 12, 2019
Primary Completion
June 30, 2020
Study Completion
May 3, 2021
Last Updated
September 22, 2021
Results First Posted
August 25, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share