Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient

September 2, 2021 updated by: Maria Bano

This is a single center prospective longitudinal exercise training study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years.

Participants will undergo an MRI of the Fontan circulation. This will include imaging of the heart, lung and liver. This will include specific imaging for tissue characterization and assessment of myocardial fibrosis, liver fibrosis and disproportionate pulmonary blood flow. The investigators will then draw blood (approximately 10 ml) for assessment of serum biomarkers and circulating microRNAs of interest. The participants will undergo exercise testing and will then start a 3-6 month long cardiac rehabilitation program. After the 3-6 month study period the participants will return back for a follow up and repeat all the testing completed at enrollement.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single center prospective longitudinal study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years. The investigators will enroll from pediatric cardiology and heart failure clinics and inpatient care units at Children's Health Dallas, adult congenital heart disease clinics and inpatient care units at Clements University Hospital and the Clinical Heart Center. This study will evaluate the multimodality biomarkers for assessment of Fontan circulation including heart, liver and lung and change in these markers with exercise training.

Participants will receive an MRI of the Fontan circulation. This will include imaging of the heart, lung and liver. A blood draw (approximately 10 ml) for assessment of serum biomarkers and circulating microRNAs of interest will be completed. The participants will also complete exercise testing and will then start a 3-6 month long cardiac rehabilitation program. Frequent phone follow up (conducted by the research staff) and regular download of data from heart rate monitors will ensure adherence.

After the 3-6 month study period the participants will return for a follow up and repeat all testing completed at enrollment.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Irving, Texas, United States, 75063
        • Children'sMCD

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.

Eligibility Criteria

Ages Eligible for Study

10 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of a congenital heart defect that leads to single ventricle physiology
  • Previously performed TCPA surgery
  • Current age 10 years to 40 years
  • Informed consent

Exclusion Criteria:

  • History of exercise intolerance (peak VO2<12ml/kg/min)
  • Unstable arrhythmia at the time of screening
  • Listed or being evaluated for heart transplantation
  • Pregnancy or breast feeding
  • Patient with pacemaker, AV block other than 1st degree block, sick sinus syndrome or other arrhythmia that may influence ability to perform exercise test or magnetic resonance imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fontan Patients
All Fontan patients included in this study will be part of an exercise intervention 2-6 times/week for 3-6 months.
Behavioral: Exercise
Exercise training all patients enrolled.
Other Names:
  • Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak VO2
Time Frame: 6 months
Improvement in Peak VO2 with 6 months of exercise training
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Bano

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 Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 25, 2017

First Posted (Actual)

August 28, 2017

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 122016-037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Fibrosis

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe