University of Wisconsin-Madison
Madison, Wisconsin, 53792, United States
NCT Number: NCT02967315
The purpose of this study is to evaluate the correlation between fluid volume status and right ventricular volume and function, in those with free pulmonary valve insufficiency after Tetralogy of Fallot (TOF) repair.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53792, United States
The purpose of this study is to measure the changes in Right Ventricular size and function with changes in preload, using cardiovascular magnetic resonance (CMR). Based on an intensive research and clinical observations the investigators hypothesize that changes in volume status cause a statistically significant difference in the Cardiovascular magnetic resonance (CMR) measured RV End Diastolic Volume (EDV), end-systolic volume (ESV), ejection fraction (EF) and pulmonary regurgitation (PR). The investigator hypothesizes that smaller changes will occur in left ventricular LV EDV, ESV, and EF.
This study will be conducted in compliance with this protocol, good clinical practice and the applicable regulatory requirements.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
There will be 2 CMRIs. The first one will be patient's routine clinically schedule CMRI after the patient has fasted for 12 hours.This CMRI uses contrast.
The second CMRI will be the research CMRI after the fluid administration. This CMRI does not use contrast.
An ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia.
A chest X-ray will be performed for safety reasons to rule out pneumothorax (< 1% risk) after central line placement.
Administration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration.
One to two teaspoons of blood will be drawn for basic metabolic panel.
A urine pregnancy test will be performed in female subjects.
12 lead ECG
Time frame: 24 months
The following will be measured to define the postload volume status: Left and right ventricle end diastolic volume (milliliters [ml]); Ejection fraction (%); pulmonary regurgitation
University of Wisconsin, Madison
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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