NCT05670132 Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB)

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 290 participants in total. It began in 2024-06-03 with a primary completion date of 2027-06-03.

Brief Summary

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. These challenges adversely affect their quality of life and constitute a major public health issue. We seek to evaluate the efficacy of the first integrative and holistic program in Neuro-Cardiac Health associating physical and psychological rehabilitation for children with rare CHD compared to the standard of care. Children randomly assigned to the intervention will undergo a 12-week neuro-cardiac intervention including home-based adaptive physical exercise, telehealth parent and child psycho-education and child computerized cognitive training, as well in-person individual sessions of intervention reinforcement. Parents will be actively involved and will receive personalized feedback and educational resources. Children assigned to the control group will receive the standard of care in congenital cardiology. Post-intervention effects will be measured after 12-months on several outcomes including health-related quality of life (HRQoL), trained and untrained cognitive skills, mental health outcomes and cardiovascular/physical variables.

Eligibility Criteria

Inclusion Criteria: 1. Patient with a CHD of moderate to great complexity as defined in the 2019 AHA/ACC guidelines (Appendix 2)85. 2. History of cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life. 3. Age between 8 and 25 years at the time of enrolment. 4. Parental or legal guardian's consent for minors (\<18 years) and personal consent for adults. 5. Social security affiliation (for France only) Exclusion Criteria: 1. 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 enrolment), systolic ventricle dysfunction (left ventricle or systemic ventricle ejection fraction \< 50%)82. 2. Severe hypoxaemia: pulse oxygen saturation (SpO2) at rest \<85%, and/or SpO2 at exercise \<80%, and/or patient requiring oxygen therapy. 3. Pulmonary hypertension as defined by the 2020 ESC guidelines, whatever the aetiology83. 4. Significant systolic right ventricle (sRV) hypertension (sRV pressure \> 50% of systemic systolic pressure). 5. 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 CPET, occurrence or aggravation of any supraventricular or ventricular arrhythmia during exercise and/or CPET. 6. Advanced atrioventricular block (degree 2 or 3), occurrence or aggravation of any conduction disorder during exercise and/or CPET. 7. 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). 8. Acute or recent (\< 3 months) myocarditis and pericarditis. 9. Symptomatic aortic or sub-aortic stenosis (mean gradient \> 50 mmHg). 10. Non-corrected coarctation of the aorta (surgical or catheter-based repair) with a clinical systolic gradient \> 20 mmHg. 11. 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 inherent in the malformation and without risk of aortic dissection (tetralogy of Fallot, pulmonary atresia with IVC, common trunk artery). 12. Severe hypertrophic obstructive cardiomyopathy. 13. Acute systemic illness. 14. Recent (\<3 months) intracardiac thrombus, embolism, or thrombophlebitis. 15. Inability to follow instructions and/or complete the questionnaires, as determined by the investigator. 16. Absolute contraindications for CPET: fever, uncontrolled asthma, respiratory failure, acute myocarditis or pericarditis, uncontrolled arrhythmias causing symptoms or haemodynamic compromise, uncontrolled heart failure, acute pulmonary embolus or pulmonary infarction, and patients with mental impairment leading to inability to cooperate. 17. 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 as cardiac surgery, catheter-based intervention, orthopaedic surgery, chemotherapy for cancer, or any other significant medical treatment or intervention, as determined by the investigator). 18. Patient with a previously diagnosed severe psychiatric disorder requiring hospitalization and/or continuous specialized care by a psychiatrist, as determined by the investigator. 19. Patients who benefited from a cardiac rehabilitation within the 12 months preceding the enrolment. 20. Patients who benefited from a computerized executive function or attention training such as Cogmed Working Memory Program within the 12 months preceding the enrolment. 21. For female patients: pregnancy, pregnancy plan, or breastfeeding woman following questioning of the patient. 22. Patients deprived of liberty due to an ongoing legal procedure, adult's patient under guardianship or curatorship or unable to personally express their consent. 23. Any other clinical and/or pharmacological treatment that is believed to interfere with the study or the optimal clinical care. 24. 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. 25. Patient participating or wishing to participate in any interventional clinical research (drug trial, medical device, non-drug trial).

Contact & Investigator

Frequently Asked Questions

Related Trials