NCT02967315

Effects of Changes in Fluid Status on Right Ventricular Volumes and Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. 1. To establish a correlation between the changes in preload volume status and RV size and function in patients with free pulmonary insufficiency (PI) after TOF repair using CMRI. 2. To assess the effects of preload status on the measured severity of pulmonary regurgitation (PR). 3. To assess the effects of preload status on the left ventricular (LV) size This study will be conducted in compliance with this protocol, good clinical practice and the applicable regulatory requirements.

Conditions

• Tetralogy of Fallot

Interventions

Type	Name	Description
PROCEDURE	Cardiac Magnetic Resonance Imaging (CMRI)	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.
PROCEDURE	Central venous line placement	An ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia.
PROCEDURE	Chest X-ray	A chest X-ray will be performed for safety reasons to rule out pneumothorax (\< 1% risk) after central line placement.
PROCEDURE	Fluid administration	Administration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration.
PROCEDURE	Blood Draw	One to two teaspoons of blood will be drawn for basic metabolic panel.
PROCEDURE	Pregnancy test	A urine pregnancy test will be performed in female subjects.
PROCEDURE	Electrocardiogram	12 lead ECG

Timeline

• Start date: 2014-06-06
• Primary completion: 2021-03-18
• Completion: 2021-03-18
• First posted: 2016-11-18
• Last updated: 2021-04-14

Locations

1 site across 1 country: United States