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New treatment option for Congenital Heart Disease
Official title Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB)
ClinicalTrials.gov ID: NCT05670132
What this study is testing
- What it's testing
- Remarkable progress in paediatric cardiology and surgery have led to the substantial increase of congenital heart disease (CHD) survivors. Long-term outcomes in rare and complex CHD have become a critical priority as three major sources of morbidity have been identified in this population: neurodevelopmental sequelae, mental health issues and reduced exercise capacity.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 25
You may be able to join if
- Patient with a CHD of moderate to great complexity as defined in the 2019 AHA/ACC guidelines (Appendix 2)85.
- History of cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life.
- Age between 8 and 25 years at the time of enrolment.
- Parental or legal guardian's consent for minors (\<18 years) and personal consent for adults.
- Social security affiliation (for France only)
You likely can't join if
- Unstable and/or severe heart failure: severe heart failure (class IV NYHA functional class), recent decompensated heart failure requiring...
- Severe hypoxaemia: pulse oxygen saturation (SpO2) at rest \<85%, and/or SpO2 at exercise \<80%, and/or patient requiring oxygen therapy.
- Pulmonary hypertension as defined by the 2020 ESC guidelines, whatever the aetiology83.
- Significant systolic right ventricle (sRV) hypertension (sRV pressure \> 50% of systemic systolic pressure).
- Uncontrolled arrhythmia: symptomatic treated or untreated arrhythmia at rest and/or exercise, treated arrhythmia with sustained supraventricular or...
- Advanced atrioventricular block (degree 2 or 3), occurrence or aggravation of any conduction disorder during exercise and/or CPET.
See the full eligibility criteria
- Patient with a CHD of moderate to great complexity as defined in the 2019 AHA/ACC guidelines (Appendix 2)85.
- History of cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life.
- Age between 8 and 25 years at the time of enrolment.
- Parental or legal guardian's consent for minors (\<18 years) and personal consent for adults.
- Social security affiliation (for France only)
- Unstable and/or severe heart failure: severe heart failure (class IV NYHA functional class), recent decompensated heart failure requiring hospitalisation and/or any significant change in medication (\< 3 months before...
- Severe hypoxaemia: pulse oxygen saturation (SpO2) at rest \<85%, and/or SpO2 at exercise \<80%, and/or patient requiring oxygen therapy.
- Pulmonary hypertension as defined by the 2020 ESC guidelines, whatever the aetiology83.
- Significant systolic right ventricle (sRV) hypertension (sRV pressure \> 50% of systemic systolic pressure).
- Uncontrolled arrhythmia: symptomatic treated or untreated arrhythmia at rest and/or exercise, treated arrhythmia with sustained supraventricular or ventricular tachycardia on ECG monitoring or during exercise and/or...
- Advanced atrioventricular block (degree 2 or 3), occurrence or aggravation of any conduction disorder during exercise and/or CPET.
- Uncontrolled arterial hypertension at rest (e.g. if the blood pressure at rest during the consultation \>140/90 mmHg in adults, \>95th percentile in children84).
- Acute or recent (\< 3 months) myocarditis and pericarditis.
- Symptomatic aortic or sub-aortic stenosis (mean gradient \> 50 mmHg).
- Non-corrected coarctation of the aorta (surgical or catheter-based repair) with a clinical systolic gradient \> 20 mmHg.
- Dilatation of the aorta (aortic root \> 40 mm in adults, \> 2 Z-score in children85 (http://www.parameterz.com/sites/aortic-root) except in the case of repaired congenital heart disease with dilatation of the aorta...
- Severe hypertrophic obstructive cardiomyopathy.
- Acute systemic illness.
- Recent (\<3 months) intracardiac thrombus, embolism, or thrombophlebitis.
- Inability to follow instructions and/or complete the questionnaires, as determined by the investigator.
- Absolute contraindications for CPET: fever, uncontrolled asthma, respiratory failure, acute myocarditis or pericarditis, uncontrolled arrhythmias causing symptoms or haemodynamic compromise, uncontrolled heart failure...
- Inability to undergo the physical intervention: inability to physically exercise, any invasive medical intervention occurring within 6 months preceding the enrolment or scheduled during the 12-month study period (such...
- Patient with a previously diagnosed or suspected severe psychiatric disorder (major depression with or without suicidal ideation, psychotic diagnoses, severe anxiety /panic disorders) requiring hospitalization and/or...
- Patients who benefited from a cardiac rehabilitation within the 12 months preceding the enrolment.
- Patients who benefited from a computerized executive function or attention training such as Cogmed Working Memory Program within the 12 months preceding the enrolment.
- For female patients: pregnancy, pregnancy plan, or breastfeeding woman following questioning of the patient.
- Patients deprived of liberty due to an ongoing legal procedure, adult's patient under guardianship or curatorship or unable to personally express their consent.
- Any other clinical and/or pharmacological treatment that is believed to interfere with the study or the optimal clinical care.
- Initiation or total withdrawal of psychotropic medication (i.e., any psychotropic medication including methylphenidate, benzodiazepines, and mood stabilizers) within the 6 months preceding the enrolment.
- Patient participating or wishing to participate in any treatment clinical research (drug trial, medical device, non-drug trial).
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Paris, France, France
- Montpellier, France
- Palavas-les-Flots, France
- Pessac, France
- München, Germany
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 8 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Paris, France, France; Montpellier, France; Palavas-les-Flots, France; Pessac, France; München, Germany. 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.