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Effects Branch PA Stenting d-TGA, ToF and TA

Primary Purpose

Transposition of Great Vessels, Tetralogy of Fallot, Truncus Arteriosus

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Percutaneous intervention (stent) for PA stenosis
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transposition of Great Vessels focused on measuring Exercise capacity

Eligibility Criteria

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

Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients with d-TGA post ASO, ToF or TA ≥8 years Exclusion Criteria: One or more of the following inclusion criteria: All class IIa indications for a branch PA intervention: Persistent decreased RV function (based on gold standard CMR) <18 years RVEF ≤55% (28) ≥18 years RVEF<50% (29) Progressive tricuspid regurgitation (TR) (≥moderate) Isolated bifurcation stenosis: Significant unilateral stenosis (≥50%) Borderline bilateral PA stenosis (40-70%) Unbalanced perfusion (≤35/65%) RV/LV pressure ratio > 2/3 based on echocardiography Reduced lung perfusion or decreased objective exercise capacity (based of gold standard VO2 max during CPET) <18 years VO2 peak <35 mL∙kg-1∙min-1 (boys) VO2 peak <30 mL∙kg-1∙min-1 (girls) (30) ≥18 years VO2 peak <27 mL∙kg-1∙min-1 (men) VO2 peak <19 mL∙kg-1∙min-1 (women) (31)

Sites / Locations

  • Amsterdam University Medical Center location AMC
  • Leiden University Medical Center
  • Erasmus Medical Center
  • UMC Utrecht/WKZRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional group

Control group

Arm Description

Percutaneous intervention for PA stenosis

Conservative management (percutaneous intervention for PA stenosis 6 months postponed)

Outcomes

Primary Outcome Measures

Change from baseline VO2max as percentage of predicted at 6 months as indication of exercise capacity
using cardiopulmonary exercise test on a treadmill

Secondary Outcome Measures

Technical success using invasive right ventricular and pulmonary artery pressures and gradients
Technical success of the intervention using invasive right ventricular and pulmonary artery pressures and gradients
Peak workload (W)
using cardiopulmonary exercise test on a treadmill
Peak workload (% predicted)
using cardiopulmonary exercise test on a treadmill
O2 pulse (ml)
using cardiopulmonary exercise test on a treadmill
O2 pulse (% predicted)
using cardiopulmonary exercise test on a treadmill
VE/VCO2 slope
using cardiopulmonary exercise test on a treadmill
Right ventricular ejection fraction (%)
using CMR
RV strain (%)
using speckle tracking echocardiography and CMR feature tracking
RV fractional area change (%)
using echocardiography
RV pressure (mmHg)
using echocardiography (TI gradient)
RV end-systolic elastance
using pressure-volume analysis
RV end systolic volume (ml and ml/m2)
using CMR
RV end diastolic volume (ml and ml/m2)
using CMR
RV functional reserve
RVEF dobutamine - RVEF rest using a low dose dobutamine stress MRI
RV mass (g and g/m2)
using CMR
Right ventricular pulmonary arterial (RV-PA) coupling
using pressure-volume analysis
Lung perfusion (%)
using CMR
Quality of Life (QoL) in 4 domains: health and related activities, emotional, social and school/work
using PedsQL questionnaire

Full Information

First Posted
March 15, 2023
Last Updated
May 15, 2023
Sponsor
UMC Utrecht
Collaborators
Dutch Heart Foundation, Hartekind, Erasmus Medical Center, Leiden University Medical Center, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
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1. Study Identification

Unique Protocol Identification Number
NCT05809310
Brief Title
Effects Branch PA Stenting d-TGA, ToF and TA
Official Title
The Effects of Branch Pulmonary Artery Stenting in d-TGA, ToF and TA: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
Dutch Heart Foundation, Hartekind, Erasmus Medical Center, Leiden University Medical Center, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The main question[s] it aims to answer are: The primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions. Participants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht/WKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions. Researchers will compare the difference in VO2 max (% predicted) between the interventional group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo a percutaneous intervention for a PA stenosis) and the control group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo conservative management)
Detailed Description
Rationale: Postoperative survival of patients with dextro transposition of the great arteries (d-TGA), Tetralogy of Fallot (ToF) and Truncus Arteriosus (TA) has increased over the last decades due to advances in operative techniques and perioperative care. Despite postoperative survival has increased, morbidity of these patients increases during long-term follow-up with a high need for reinterventions. Right ventricular outflow tract (RVOT) obstructions are the most common indication for a reintervention and percutaneous branch pulmonary artery (PA) interventions account for a significant number of these reinterventions. However, the effects of percutaneous branch PA interventions on exercise capacity, RV function and RV adaptation of patients with d-TGA, ToF and TA remains largely unknown. In addition, there is no consensus about the optimal timing for percutaneous interventions for branch PA stenosis in international guidelines. Objective: The primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions. Study design: This is a multicenter randomized controlled trial. Patients will be included from the following Dutch interventional centers for congenital heart disease: UMC Utrecht/WKZ (sponsor), LUMC/AUMC and Erasmus MC. During this trial there will be two groups: 1. a group of patients with d-TGA, ToF and TA who will undergo a percutaneous intervention for a branch PA stenosis according to standard care (intervention group) and 2. a group of patients with d-TGA, ToF and TA with a similar degree of pulmonary stenosis as group 1 (class IIa indication) who will undergo conservative management for a branch PA stenosis according to standard care (control group). If necessary, the control group will be able to undergo a percutaneous intervention for branch PA stenosis after the examinations at approximately 6 months follow-up, or sooner in case of symptoms. Patients from both groups will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht/WKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions. Study population: d-TGA post ASO, ToF or TA patients ≥8 years old will be included if they have a class IIa indication for a percutaneous intervention for branch PA stenosis according to the international guidelines. Patients will be excluded if they contraindications for one of the examinations. Main study parameters/endpoints: the difference in VO2 max (% predicted) as parameter for exercise capacity between the interventional and control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transposition of Great Vessels, Tetralogy of Fallot, Truncus Arteriosus, Pulmonary Artery Stenosis Supravalvular Congenital, Stent Stenosis, Right Ventricular Dysfunction, Congenital Heart Disease
Keywords
Exercise capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Percutaneous intervention for PA stenosis
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Conservative management (percutaneous intervention for PA stenosis 6 months postponed)
Intervention Type
Procedure
Intervention Name(s)
Percutaneous intervention (stent) for PA stenosis
Intervention Description
Percutaneous intervention (stent placement) in one or both of the branch pulmonary arteries
Primary Outcome Measure Information:
Title
Change from baseline VO2max as percentage of predicted at 6 months as indication of exercise capacity
Description
using cardiopulmonary exercise test on a treadmill
Time Frame
change between baseline and 6 months follow-up
Secondary Outcome Measure Information:
Title
Technical success using invasive right ventricular and pulmonary artery pressures and gradients
Description
Technical success of the intervention using invasive right ventricular and pulmonary artery pressures and gradients
Time Frame
after the intervention, an average of 1 month after baseline
Title
Peak workload (W)
Description
using cardiopulmonary exercise test on a treadmill
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
Peak workload (% predicted)
Description
using cardiopulmonary exercise test on a treadmill
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
O2 pulse (ml)
Description
using cardiopulmonary exercise test on a treadmill
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
O2 pulse (% predicted)
Description
using cardiopulmonary exercise test on a treadmill
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
VE/VCO2 slope
Description
using cardiopulmonary exercise test on a treadmill
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
Right ventricular ejection fraction (%)
Description
using CMR
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
RV strain (%)
Description
using speckle tracking echocardiography and CMR feature tracking
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
RV fractional area change (%)
Description
using echocardiography
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
RV pressure (mmHg)
Description
using echocardiography (TI gradient)
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
RV end-systolic elastance
Description
using pressure-volume analysis
Time Frame
before and after the intervention, an average of 1 month after baseline
Title
RV end systolic volume (ml and ml/m2)
Description
using CMR
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
RV end diastolic volume (ml and ml/m2)
Description
using CMR
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
RV functional reserve
Description
RVEF dobutamine - RVEF rest using a low dose dobutamine stress MRI
Time Frame
at baseline and 6 months follow-up in the interventional group from UMC Utrecht and Erasmus MC
Title
RV mass (g and g/m2)
Description
using CMR
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
Right ventricular pulmonary arterial (RV-PA) coupling
Description
using pressure-volume analysis
Time Frame
before and after the intervention, an average of 1 month after baseline
Title
Lung perfusion (%)
Description
using CMR
Time Frame
at baseline, 6 months follow-up and 2-4 years follow-up
Title
Quality of Life (QoL) in 4 domains: health and related activities, emotional, social and school/work
Description
using PedsQL questionnaire
Time Frame
at baseline and 2 weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients with d-TGA post ASO, ToF or TA ≥8 years Exclusion Criteria: One or more of the following inclusion criteria: All class IIa indications for a branch PA intervention: Persistent decreased RV function (based on gold standard CMR) <18 years RVEF ≤55% (28) ≥18 years RVEF<50% (29) Progressive tricuspid regurgitation (TR) (≥moderate) Isolated bifurcation stenosis: Significant unilateral stenosis (≥50%) Borderline bilateral PA stenosis (40-70%) Unbalanced perfusion (≤35/65%) RV/LV pressure ratio > 2/3 based on echocardiography Reduced lung perfusion or decreased objective exercise capacity (based of gold standard VO2 max during CPET) <18 years VO2 peak <35 mL∙kg-1∙min-1 (boys) VO2 peak <30 mL∙kg-1∙min-1 (girls) (30) ≥18 years VO2 peak <27 mL∙kg-1∙min-1 (men) VO2 peak <19 mL∙kg-1∙min-1 (women) (31)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Breur, MD, PhD
Phone
+31 88 75 754 59
Email
h.breur@umcutrecht.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Renée Joosen, MSc
Email
r.s.joosen-2@umcutrecht.nl
Facility Information:
Facility Name
Amsterdam University Medical Center location AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nico A Blom, MD, PhD
Email
N.A.Blom@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Renée S Joosen, MSc
Email
r.s.joosen-2@umcutrecht.nl
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nico A Blom, MD, PhD
Email
N.A.Blom@lumc.nl
First Name & Middle Initial & Last Name & Degree
Renée S Joosen, MSc
Email
r.s.joosen-2@umcutrecht.nl
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015 CN
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas B Krasemann, MD, PhD
Email
t.krasemann@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Renée S Joosen, MSc
Email
r.s.joosen-2@umcutrecht.nl
Facility Name
UMC Utrecht/WKZ
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes MPJ Breur, MD, PhD
Phone
0031887575459
Email
h.breur@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Renée S Joosen, MSc
Email
r.s.joosen-2@umcutrecht.nl

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will publish the results in peer-reviewed journals and present them at meetings and conferences. As the data is privacy-sensitive, the database will not be publically available. A request for a collaboration can be made via DataverseNL.

Learn more about this trial

Effects Branch PA Stenting d-TGA, ToF and TA

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