Effects of Changes in Fluid Status on Right Ventricular Volumes and Function
Completed · Not applicable
Conditions studied: Tetralogy of Fallot
In brief
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.
Key facts
- Study ID
- NCT02967315
- Run by
- University of Wisconsin, Madison
- People needed
- 4
- Starts
- 2014-06-06
- Expected to finish
- 2021-03-18
- Last updated by the study team
- 2021-04-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- TOF patients who have had repair using a transannular patch.
- Patients that present with free pulmonary insufficiency.
- Are older than 18 years.
You may not qualify if…
- Patients who have lesions predisposing to chronic volume overload (i.e. patients with significant residual postoperative ventricular septal defects (VSD), or large aorto-pulmonary collaterals or more than moderate tricuspid insufficiency) since all these hemodynamic conditions can influence the late function of the right ventricle and potentially affect the response of the right side of the heart in changes in volume status
- Patients who had a valve sparing TOF repair and have less than free pulmonary insufficiency.
- Patients who have significant residual right-sided obstruction (i.e. patients who have residual RVOT obstruction or significant residual branch pulmonary artery stenosis), as it is shown that residual pulmonary stenosis may protect from RV dilation and from deterioration of the RV function.
- Patients who cannot be reconstructed with a transannular patch and/or require a right ventricle to pulmonary artery homograft for reconstruction including:
- pulmonary atresia and VSD
- patients with anomalous coronary crossing the right ventricular outflow tract (RVOT) and
- patients with TOF-absent pulmonary valve syndrome.
- Patients with renal failure and renal insufficiency
- Patients with uncompensated heart failure
- Cancer patients
- Latex allergic patients
- Patients with diabetes
- Pregnant females
- Prisoners
- Individuals who lack consent capacity
Where it is running
- University of Wisconsin-Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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