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New treatment option for Congenital Heart Disease
Official title High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit
ClinicalTrials.gov ID: NCT06771687
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if a specific type of exercise training (high intensity interval training) can improve exercise capacity in people with a congenital heart defect that required the creation of a new connection between the right ventricle and pulmonary artery. This includes people with a truncus arteriosus, pulmonary atresia with a ventricular septal defect or severe tetralogy of Fallot.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 45
You may be able to join if
- Congenital absence of an unobstructed connection between the right ventricle and pulmonary artery, requiring surgical implantation of a right...
- Truncus arteriosus
- Pulmonary atresia with ventricular septum defect
- Severe tetralogy of Fallot
- Other forms of pulmonary atresia with biventricular correction
You likely can't join if
- Ventricular arrhythmias and/or channelopathy.
- Implantable cardioverter defibrillator implantation due to inherited arrhythmia syndromes.
- Left ventricular ejection fraction and/or right ventricular ejection fraction less than 30 percent.
- Elite athletes (i.e. national team, Olympians, professional athletes, exercising equal to or more than 10 h/week, according to definition in 2020...
- Cardiovascular lesions requiring intervention (according to international guidelines).
- Cardiovascular intervention (surgery or catheterization) less than 6 months ago.
See the full eligibility criteria
- Congenital absence of an unobstructed connection between the right ventricle and pulmonary artery, requiring surgical implantation of a right ventricle to pulmonary artery conduit, including patients with:
- Truncus arteriosus
- Pulmonary atresia with ventricular septum defect
- Severe tetralogy of Fallot
- Other forms of pulmonary atresia with biventricular correction
- Age 12 to 45 years.
- Current follow-up in Academic Center for Congenital Heart Disease (ACAHA; Erasmus MC Rotterdam and Radboudumc Nijmegen).
- Signed informed consent.
- Ventricular arrhythmias and/or channelopathy.
- Implantable cardioverter defibrillator implantation due to inherited arrhythmia syndromes.
- Left ventricular ejection fraction and/or right ventricular ejection fraction less than 30 percent.
- Elite athletes (i.e. national team, Olympians, professional athletes, exercising equal to or more than 10 h/week, according to definition in 2020 European Society of Cardiology Guidelines for Sports Cardiology and...
- Cardiovascular lesions requiring intervention (according to international guidelines).
- Cardiovascular intervention (surgery or catheterization) less than 6 months ago.
- Cardiovascular medication changes less than 3 months ago.
- Hospitalization for treatment of cardiovascular events less than 6 months ago.
- Comorbidities or developmental delay impeding exercise training (e.g. neuromuscular disease, symptomatic myocardial ischemia, syndromic diagnoses such as trisomy 21).
- Inability to provide informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Gelderland, Netherlands
- Rotterdam, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Gelderland, Netherlands; Rotterdam, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.