Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06110689
Other study ID # 2023-0400
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 3, 2023
Est. completion date February 2025

Study information

Verified date October 2023
Source Children's Hospital Medical Center, Cincinnati
Contact Jamie Sinton, MD
Phone (419) 236-7480
Email jamie.sinton@cchmc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Fontan Procedure is a palliative surgical procedure used in pediatric patients with one functional ventricle. The procedure, a series of stepwise operations that alter cardiorespiratory physiology, separate the systemic and pulmonary circulations to create Fontan physiology, where the systemic venous blood flows passively and without ventricular thrust into the pulmonary circulation. The hallmark of the Fontan circulation is a sustained, abnormally elevated central venous pressure combined with decreased cardiac output, especially during periods of increased demands. Results of several studies in Fontan patients have shown reduced parasympathetic and sympathetic activity compared to controls. In children with congenital heart disease, a differential diagnosis of autonomic dysfunction may be part of their pathophysiology, a compensatory mechanism, a consequence of surgical procedures or a combination of these. In children, measurement of ANS function is equally important. Children with single ventricle physiology (and other cardiac conditions) have routine surveillance and cardiac magnetic resonance (CMR) imaging to monitor for disease progression. While autonomic data is routinely collected and is available from these scans, these data are rarely, collected and analyzed; however, our group has shown feasibility. Therefore, autonomic data is usually unavailable in children. Despite the availability of agerelated normal values, the predictive power of autonomic activity is understudied in children and there are no published studies of quantification of autonomic data in this population.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date February 2025
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 1 Day to 30 Years
Eligibility Inclusion Criteria: - Ages 0 to = 30 years - Baseline sinus rhythm (interventricular conduction delays and bundle branch blocks allowed); and undergoing CMR scan in which sequences containing timing of aortic valve opening (cine), vector cardiogram (VCG) and respiratory bellows use will be obtained - Fontan physiology - only for the Fontan group. Chest wall deformity or arrhythmogenic right ventricular cardiomyopathy for the healthy control group Exclusion Criteria: - Patient or family refusal; - Contraindication to study procedures - Prior participation in the study (ie, we plan to sample without replacement)

Study Design


Intervention

Other:
VU-AMS device
Patients will wear the VU-AMS monitor prior to MRI.

Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Describe difference in respiratory sinus arrhythmia in participants with Fontan Collection of data from the cardiac MRI Through MRI completion up to one hour
Other Describe difference in respiratory sinus arrhythmia in participants with pectus Collection of data from the cardiac MRI Through MRI completion up to one hour
Other Compare estimate of pre-ejection period (PEP) Collection of data from VU-AMS monitor Prior to MRI scan up to 10 minutes
Other Compare estimate of pre-ejection period (PEP) Collection of data from the cardiac MRI Through MRI completion up to one hour
Primary 80% availability of respiratory sinus arrhythmia from cardiac MRI (magnetic resonance imaging) Data collected during MRI Through MRI completion up to one hour
See also
  Status Clinical Trial Phase
Completed NCT05034601 - ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure N/A
Completed NCT02552186 - Non-invasive Clinical Pectus Index as a Measurement of Severity in Pectus N/A
Recruiting NCT04167865 - Effects of Exercise Therapy on Pectus Excavatum N/A
Completed NCT05443113 - Young Pectus Excavatum Patients and Genetic Defects
Completed NCT04362878 - Psychological Assessment of Patients With Chest Wall Deformities
Completed NCT02009267 - Nuss Procedure: Clinical Options in Pediatric Pain Management? N/A
Recruiting NCT01486953 - Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum Phase 4
Completed NCT02169297 - Sub-Paraspinal Block in Nuss Patients. A Pilot Project Phase 4
Completed NCT02174796 - Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities N/A
Recruiting NCT04211935 - Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum N/A
Completed NCT02721017 - Cryoanalgesia vs. Epidural in the Nuss Procedure Phase 4
Completed NCT02337621 - Pain, Exercise and Psychological Well-being in Pectus Excavatum
Terminated NCT01863498 - Prospective Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA N/A
Recruiting NCT04418583 - Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging N/A
Active, not recruiting NCT05063695 - Pectus ESC Outcomes and Comparative Effectiveness Study
Completed NCT01816373 - Non-invasive Negative Pressure Treatment for Pectus Excavatum N/A
Withdrawn NCT02376634 - Hypnotherapy in Major Surgical Procedures N/A
Not yet recruiting NCT06436755 - Serratus Anterior Plane Block and Transthoracic Plane Block in Pectus Surgery
Completed NCT02163265 - Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Functions N/A
Completed NCT02958683 - Chest Wall Motion Analysis in Disease