RECRUITING

Fibrosis and the Fontan

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Conditions

Single-ventricle

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to non-invasively characterize the fibrotic consequences of single ventricle physiology, its possible solution and effect on lymphatics. This project investigates the response to acute imposition of Fontan hemodynamics by examining the interrelationship between liver and cardiac fibrosis/dysfunction and lymphatic congestion along with a pilot trial of the antifibrotic agent, spironolactone, to prevent these consequences and to determine if MRI can discern these differences. The combination of serum biomarkers and MRI form a powerful non-invasive tool in putting together this complicated web of dysfunction.

Official Title

Acute Imposition of Fontan Physiology in The Single Ventricle Patient: Effects on Fibrosis, Function and Drug Intervention

Quick Facts

Study Start:2021-02-11
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04901975

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Single Ventricle (SV) Patients
  2. * Subjects between 1 and ≤ 6 years of age of either gender.
  3. * Either single left or single right ventricle.
  4. * Subjects who are scheduled to undergo a Fontan operation at CHOP.
  5. * Parents signing informed consent.
  6. * Subjects who were enrolled in this study in Cohort 2 and are either non-compliant with the medication, no longer want to take the medication, or have an AE that requires them to stop the medication, and patient's family would like to continue participation
  7. * Patients were on study medication for 6 weeks or less.
  8. * The principal investigator deems it appropriate for the patient to switch to the observational arm.
  9. * Patients signing the observational informed consent form.
  10. * Subjects between 1 and ≤6 years of age of either gender.
  11. * Either single left or single right ventricle.
  12. * Subjects who are planned to undergo a Fontan operation at CHOP.
  13. * Patients in other interventional studies approved by principal investigator.
  14. * Patients signing the observational informed consent form.
  15. * Subjects between 1 and ≤ 6 years of age of either gender.
  16. * Either single left or single right ventricle.
  17. * Subjects who are scheduled to undergo a Fontan operation at CHOP.
  18. * Parents signing informed consent.
  19. * Subjects between 1 and ≤ 6 years of age of either gender
  20. * Subjects with normal ventricular function and normal livers who present to CMR for clinical indications and require anesthesia.
  21. * Receiving contrast for clinical purposes. No control patient will receive contrast for research purposes.
  22. * Parents signing informed consent.
  1. * Subjects with any condition judged by the patient's physician that would cause this trial to be detrimental to the patient.
  2. * Any contradiction to a sedated CMR (i.e. presence of a pacemaker).
  3. * Patient currently taking spironolactone or eplerenone
  4. * Subjects in any study that would preclude participation in the study by altering results
  5. * Subjects with any condition judged by the patient's physician that would cause this trial to be detrimental to the patient.
  6. * Any contradiction to a sedated CMR (i.e. presence of a pacemaker).
  7. * Subjects in any study that would preclude participation in the current study.
  8. * Subjects with any condition judged by the patient's physician that would cause this trial to be detrimental to the patient.
  9. * Any contradiction to a sedated CMR (i.e. presence of a pacemaker).
  10. * Patient currently taking spironolactone or eplerenone
  11. * Subjects in any study that would preclude participation in the current study or studies not approved by principal investigator.
  12. * Subjects with any condition judged by the patient's physician that would cause this trial to be detrimental to the patient.
  13. * Any contradiction to a sedated CMR (i.e. presence of a pacemaker).
  14. * Patient currently taking spironolactone or eplerenone
  15. * Subjects with hyperkalemia or Addison disease;
  16. * Subjects on enalapril or other angiotensin receptor blockers
  17. * Subjects with a history of hypersensitivity to spironolactone suspension or any component of the formulation
  18. * Subjects with a clinically documented diagnosis of severe renal insufficiency (implying estimated glomerular filtration rate (eGFR) \<30 mL/minute/1.73 m2).
  19. * Subjects in any study that would preclude participation in the study by altering results
  20. * Any condition judged by the patient's physician that would cause this trial to be detrimental to the patient.
  21. * Any contradiction to a sedated CMR (i.e. presence of a pacemaker).
  22. * Patient currently taking spironolactone, eplerenone or an angiotensin converting the enzyme inhibitor/angiotensin receptor blocker.

Contacts and Locations

Study Contact

Mark Fogel, MD
CONTACT
215-590-4040
fogel@chop.edu
Cassandra L Giner, MS
CONTACT
915-503-3642
ginerc@chop.edu

Principal Investigator

Mark Fogel, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19130
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

  • Mark Fogel, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-11
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-02-11
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Single-ventricle