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Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient

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ClinicalTrials.gov Identifier: NCT03263312
Recruitment Status : Unknown
Verified August 2017 by Maria Bano, Children's Medical Center Dallas.
Recruitment status was:  Not yet recruiting
First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Maria Bano, Children's Medical Center Dallas

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Single-ventricle Myocardial Fibrosis Behavioral: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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 Name: Training




Primary Outcome Measures :
  1. Peak VO2 [ Time Frame: 6 months ]
    Improvement in Peak VO2 with 6 months of exercise training



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Responsible Party: Maria Bano, Assistant Professor, Children's Medical Center Dallas
ClinicalTrials.gov Identifier: NCT03263312    
Other Study ID Numbers: STU 122016-037
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Bano, Children's Medical Center Dallas:
myocardial fibrosis
exercise training
Fontan
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes