Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in France / NCT05670132
Recruiting Not applicable

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

NCT05670132 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-06-03
Last updated
2026-07-08

Condition(s) studied

Congenital Heart Disease

Investigational drug(s) / intervention(s)

Neurocardiac rehabilitation programStandard of care

Neurocardiac rehabilitation program: Patients receiving a neurocardiac rehabilitation program for 12 weeks.

Standard of care: No intervention during the neurocardiac rehabilitation program

Study 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

Sex
ALL
Min age
8 Years
Max age
25 Years
Healthy volunteers
No
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 significant risk of aortic dissection (tetralogy of Fallot, pulmonary atresia with VSD, transposition of the great arteries, truncus arteriosus, double outlet right ventricle, or single ventricle). 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 or suspected severe psychiatric disorder (major depression with or without suicidal ideation, psychotic diagnoses, severe anxiety /panic disorders) 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).

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Saint-Luc University Hospital Brussels Belgium Recruiting
Hôpital Necker-Enfants malades (AP-HP) Paris France Recruiting
University Hospital of Montpellier - Arnaud de Villeneuve Hospital Montpellier France Recruiting
Saint-Pierre Institute Palavas-les-Flots France Recruiting
University Hospital of Bordeaux - Haut-Levêque Hospital Pessac France Recruiting
Deutsches Herzzentrum München München Germany Not Yet Recruiting

More University Hospital, Bordeaux trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05670132 on ClinicalTrials.gov ↗ ← All trials in France