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

April 9, 2021 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. Patients who had a valve sparing TOF repair and have less than free pulmonary insufficiency.
  3. 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.

  4. 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.
  5. Patients with renal failure and renal insufficiency
  6. Patients with uncompensated heart failure
  7. Cancer patients
  8. Latex allergic patients
  9. Patients with diabetes
  10. Pregnant females
  11. Prisoners
  12. Individuals who lack consent capacity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study Group

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postload volume status
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Petros V Anagnostopoulos, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 6, 2014

Primary Completion (ACTUAL)

March 18, 2021

Study Completion (ACTUAL)

March 18, 2021

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (ESTIMATE)

November 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 9, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0399 (Other Identifier: M D Anderson Cancer Center)
  • 2013-0276 (OTHER: HS IRB)
  • SMPH/SURGERY/CARDIOTHORACIC (OTHER: A539782)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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