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NCT Number: NCT04297241

Nitrate Effect on Exercise Capacitance

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.

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Key information

Conditions

Fontan

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Isosorbide Dinitrate

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.

Other names: Isordil

Primary outcomes

  1. Number of Participants Who Experience an Adverse Reaction to the Study Medication During the Study Enrollment Period.

    Time frame: Baseline and 6 weeks

    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).

Secondary outcomes

  1. Effect of Isosorbide Dinitrate on Liver Stiffness Levels

    Time frame: Baseline and 6 weeks

    Determine effectiveness of study medication on hemodynamic profile by completing baseline and post-study medication liver ultrasound measuring liver stiffness levels by sheer wave speed (m/s).

  2. Effect of Isosorbide Dinitrate on Central Venous Pressure

    Time frame: Baseline and 6 weeks

    Determine effectiveness of study medication on hemodynamic profile by completing baseline and post-study medication maximal exercise tests to measure central venous pressure via IV catheter insertion

  3. Effect of Isosorbide Dinitrate on Maximal Exercise Capacity VO2 Max

    Time frame: Baseline and 6 weeks

    Obtain estimates of the effect the study medication has on maximal exercise test VO2 max performance in Fontan patients by study participants performing a maximal ramp exercise test on a stationary bike.

  4. Effect of Isosorbide Dinitrate on Maximal Exercise Capacity Heart Rate Response

    Time frame: Baseline and 6 weeks

    Obtain estimates of the effect the study medication has on maximal exercise test heart rate response in Fontan patients by study participants performing a maximal ramp exercise test on a stationary bike.

  5. Effect of Isosorbide Dinitrate on Maximal Exercise Capacity Respiratory Rate Response

    Time frame: Baseline and 6 weeks

    Obtain estimates of the effect the study medication has on maximal exercise test respiratory rate response in Fontan patients by study participants performing a maximal ramp exercise test on a stationary bike.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Nitrate Effect on Exercise Capacitance and Hemodynamic Profile Prior to Fontan Failure

Acronym: NEET

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 5, 2020
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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