Nitrate Effect on Exercise Capacitance

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-12

Study Completion Date

2021-05-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acute Dietary Nitrate in Dilated Cardiomyopathy

NCT02471417

Cardiomyopathy

COMPLETED NA

The Role of Nitrite in Preconditioning Mediated Tolerance to Ischemic Stress

NCT00250185

Ischemic Stress Transient Non-Lethal Ischemia

COMPLETED PHASE1

Vascular Effects of Endothelium-Derived Versus Hemoglobin-Transported Nitric Oxide in Healthy Subjects

NCT00001963

Diabetes Mellitus Healthy Hypercholesterolemia +1 more

COMPLETED PHASE1

Nitrate and Hypertension in Heart Transplanted Patients

NCT00449059

Hypertension Heart Transplantation

COMPLETED PHASE4

Effect of Nitrite on Exercise Physiology and Metabolism

NCT00105222

Healthy Healthy Volunteer HV

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fontan

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Isosorbide Dinitrate

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

Group Type EXPERIMENTAL

Isosorbide Dinitrate

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Isosorbide Dinitrate

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Isordil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No