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

Primary Purpose

Tetralogy of Fallot

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cardiac Magnetic Resonance Imaging (CMRI)

Central venous line placement

Chest X-ray

Fluid administration

Blood Draw

Pregnancy test

Electrocardiogram

About this trial

This is an interventional diagnostic trial for Tetralogy of Fallot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

TOF patients who have had repair using a transannular patch.
Patients that present with free pulmonary insufficiency.
Are older than 18 years.

Exclusion Criteria:

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

Sites / Locations

University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm Description

Procedures include: Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test

Outcomes

Primary Outcome Measures

Postload volume status

The following will be measured to define the postload volume status: Left and right ventricle end diastolic volume (milliliters [ml]); Ejection fraction (%); pulmonary regurgitation

Secondary Outcome Measures

Full Information

NCT ID

NCT02967315

First Posted

October 27, 2016

Last Updated

April 9, 2021

Sponsor

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT02967315

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

June 6, 2014 (Actual)

Primary Completion Date

March 18, 2021 (Actual)

Study Completion Date

March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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. To assess the effects of preload status on the measured severity of pulmonary regurgitation (PR). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tetralogy of Fallot

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Group

Arm Type

Experimental

Arm Description

Procedures include: Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test

Intervention Type

Procedure

Intervention Name(s)

Cardiac Magnetic Resonance Imaging (CMRI)

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Central venous line placement

Intervention Description

An ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia.

Intervention Type

Procedure

Intervention Name(s)

Chest X-ray

Intervention Description

A chest X-ray will be performed for safety reasons to rule out pneumothorax (< 1% risk) after central line placement.

Intervention Type

Procedure

Intervention Name(s)

Fluid administration

Intervention Description

Administration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration.

Intervention Type

Procedure

Intervention Name(s)

Blood Draw

Intervention Description

One to two teaspoons of blood will be drawn for basic metabolic panel.

Intervention Type

Procedure

Intervention Name(s)

Pregnancy test

Intervention Description

A urine pregnancy test will be performed in female subjects.

Intervention Type

Procedure

Intervention Name(s)

Electrocardiogram

Intervention Description

12 lead ECG

Primary Outcome Measure Information:

Title

Postload volume status

Description

The following will be measured to define the postload volume status: Left and right ventricle end diastolic volume (milliliters [ml]); Ejection fraction (%); pulmonary regurgitation

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: TOF patients who have had repair using a transannular patch. Patients that present with free pulmonary insufficiency. Are older than 18 years. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Petros V Anagnostopoulos, MD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin-Madison

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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