Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03263312
Study type	Interventional
Source	Children's Medical Center Dallas
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 1, 2018
Completion date	June 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03176862` - Left Ventricular Fibrosis in Chronic Kidney Disease	N/A
Recruiting	`NCT06039969` - Evaluate Aerobic Exercise on Myocardial Fibrosis and Intestinal Flora in Dilated Cardiomyopathy Diagnosed First Time.
Not yet recruiting	`NCT06059287` - The Effect of Henagliflozin and Metformin on Myocardial Tissue-level Characteristics	N/A
Completed	`NCT00879060` - Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy	Phase 4
Completed	`NCT02834104` - Validation of Fibrosis Quantification Using T1 Mapping Against Histology as Reference and Comparison With Fibrosis Biomarkers	N/A
Recruiting	`NCT03332745` - Mechanism of Decompensation Evaluation - Aortic Stenosis	N/A
Active, not recruiting	`NCT04444128` - IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
Recruiting	`NCT03191461` - Myocardial Perfusion and Fibrosis in Cancer Survivors
Not yet recruiting	`NCT05954559` - High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment	Phase 4
Recruiting	`NCT02428374` - Role of Immune Responses After Acute Myocardial Infarction	Phase 4
Recruiting	`NCT05867589` - Study of Novel PET Tracer Gallium [68Ga]/ Fluorine [18F] -FAPI-04 in the Diagnosis of Cardiovascular Diseases	N/A
Not yet recruiting	`NCT06326970` - SPECT Fibroblast Activation Protein Imaging in Patients With Cardiac Disease
Completed	`NCT02432885` - Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy - ACE Inhibitor Therapy Trial	Phase 3
Completed	`NCT04397198` - The Assessment Of Myocardial Viability Based On CTA/MRI Hybrid Models
Recruiting	`NCT03405987` - Association of T1-mapping and LV Strain Analysis by CMR
Completed	`NCT01160471` - Noninvasive Imaging of Heart Failure: A Pilot Study
Completed	`NCT03422770` - Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis	N/A
Not yet recruiting	`NCT03515291` - A Trial of Cardiac Injections of iMP Cells During CABG Surgery	Phase 2
Recruiting	`NCT02670031` - Response of the Myocardium to Hypertrophic Conditions in the Adult Population
Terminated	`NCT02012725` - Molecular MRI of the Fibrotic Heart	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.