Tetralogy of FallotNCT02967315
Effects of Changes in Fluid Status on Right Ventricular Volumes and Function
A study testing Cardiac Magnetic Resonance Imaging (CMRI), Central venous line placement and Chest X-ray in people with Tetralogy of Fallot, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetralogy of Fallot
- What is being tested?
- Cardiac Magnetic Resonance Imaging (CMRI), Central venous line placement and Chest X-ray
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2014to 18 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TOF patients who have had repair using a transannular patch.
- Patients that present with free pulmonary insufficiency.
- Are older than 18 years.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53792
About this study
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.
Read the 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.
- Conditions
- Tetralogy of Fallot
- Being tested
- Cardiac Magnetic Resonance Imaging (CMRI), Central venous line placement, Chest X-ray, Fluid administration, Blood Draw
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance Imaging (CMRI)Procedure or surgery
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.
Central venous line placementProcedure or surgery
An ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia.
Chest X-rayProcedure or surgery
A chest X-ray will be performed for safety reasons to rule out pneumothorax (< 1% risk) after central line placement.
Fluid administrationProcedure or surgery
Administration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration.
Blood DrawProcedure or surgery
One to two teaspoons of blood will be drawn for basic metabolic panel.
Pregnancy testProcedure or surgery
A urine pregnancy test will be performed in female subjects.
ElectrocardiogramProcedure or surgery
12 lead ECG
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | 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 Receives: Procedure: Cardiac Magnetic Resonance Imaging (CMRI); Procedure: Central venous line placement; Procedure: Chest X-ray; Procedure: Fluid administration; Procedure: Blood Draw; Procedure: Pregnancy test; Procedure: Electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start6 Jun 2014
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petros V Anagnostopoulos, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967315
- Sponsor's protocol ID
- 2018-0399
- Other IDs
- 2013-0276, SMPH/SURGERY/CARDIOTHORACIC
- Status last verified
- Apr 2021
- First submitted
- 27 Oct 2016
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Changes in Fluid Status on Right Ventricular Volumes and Function
- ClinicalTrials.gov ID
- NCT02967315
- Acronym / sponsor ID
- 2018-0399
- Conditions
- Tetralogy of Fallot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 6 Jun 2014 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: Cardiac Magnetic Resonance Imaging (CMRI), Procedure: Central venous line placement, Procedure: Chest X-ray, Procedure: Fluid administration, Procedure: Blood Draw, Procedure: Pregnancy test, Procedure: ElectrocardiogramProcedures include: Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- TOF patients who have had repair using a transannular patch.
- Patients that present with free pulmonary insufficiency.
- Are older than 18 years.
Key exclusion criteria (15 listed)
- 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:
- Patients with renal failure and renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Study Group |
| Central venous line placementAn ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia. | Procedure or surgery | Study Group |
| Chest X-rayA chest X-ray will be performed for safety reasons to rule out pneumothorax (< 1% risk) after central line placement. | Procedure or surgery | Study Group |
| Fluid administrationAdministration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration. | Procedure or surgery | Study Group |
| Blood DrawOne to two teaspoons of blood will be drawn for basic metabolic panel. | Procedure or surgery | Study Group |
| Pregnancy testA urine pregnancy test will be performed in female subjects. | Procedure or surgery | Study Group |
| Electrocardiogram12 lead ECG | Procedure or surgery | Study Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Tetralogy of Fallot
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Tetralogy of Fallot (TOF), Congenital Heart Defects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petros V Anagnostopoulos, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Magnetic Resonance Imaging (CMRI), Central venous line placement and Chest X-ray in people with Tetralogy of Fallot, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postload volume status (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.