- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05670132
Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB)
Impact of a Neuro-cardiac Rehabilitation Program on the Quality of Life of Children, Adolescents, and Young Adults With Congenital Heart Disease: the Multicentre Randomized Controlled QUALINEUROREHAB Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pascal AMEDRO, MD,PhD
- Phone Number: +33 05 57 65 61 09
- Email: pascal.amedro@chu-bordeaux.fr
Study Contact Backup
- Name: Johanna CALDERON, PhD
- Email: johanna.calderon@inserm.fr
Study Locations
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Brussels, Belgium
- Saint-Luc University Hospital
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Contact:
- Stéphane MONIOTTE, MD,PhD
- Phone Number: +32 02 764 19 20
- Email: stephane.moniotte@uclouvain.be
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Montpellier, France, 34295
- University Hospital of Montpellier - Arnaud de Villeneuve Hospital
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Contact:
- Sophie GUILLAUMONT, MD
- Phone Number: +33 04 67 33 81 12
- Email: s-guillaumont@chu-montpellier.fr
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Palavas-les-Flots, France, 34250
- Saint-Pierre Institute
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Contact:
- Sophie GUILLAUMONT, MD
- Phone Number: +33 04 67 07 75 51
- Email: guillaumont.s@institut-saint-pierre.fr
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Pessac, France, 33604
- University Hospital of Bordeaux - Haut-Levêque Hospital
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Contact:
- Pascal AMEDRO, MD,PhD
- Phone Number: +33 05 57 65 61 09
- Email: pascal.amedro@chu-bordeaux.fr
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München, Germany, D-80636
- Deutsches Herzzentrum München
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Contact:
- alfred HAGER, MD,PhD
- Phone Number: +49 089-1218-1650
- Email: hager@dhm.mhn.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion 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)
Exclusion Criteria:
- 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.
- 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 CPET, occurrence or aggravation of any supraventricular or ventricular arrhythmia during exercise and/or CPET.
- 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.
- 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).
- Severe hypertrophic obstructive cardiomyopathy diagnosed by non-echocardiography.
- 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, acute pulmonary embolus or pulmonary infarction, and patients with mental impairment leading to inability to cooperate.
- 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).
- Patient with a previously diagnosed severe psychiatric disorder requiring hospitalization and/or continuous specialized care by a psychiatrist, as determined by the investigator.
- 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 interventional clinical research (drug trial, medical device, non-drug trial).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Neurocardiac rehabilitation program
The home-based neuro-cardiac rehabilitation program will consist of weekly sessions of neuro-cardiac training during 12 weeks at home.
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Patients receiving a neurocardiac rehabilitation program for 12 weeks.
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Active Comparator: Standard of care
The control group will follow European recommendations for cardiology care (standard of care) without introducing any additional interventions for research purposes at the exception of primary (HRQoL questionnaires) and secondary outcomes
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No intervention during the neurocardiac rehabilitation program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire
Time Frame: between Month 0 and Month 12
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Change in the self-reported total score of the PedsQL 4.0 questionnaire between baseline (Month 0) and the end of follow-up (Month 12) in both groups.
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between Month 0 and Month 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proxy-reported total score of the Pediatric Quality of Life Inventory (PedsQL) for paediatric patients
Time Frame: between Month 0 and Month 12
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between Month 0 and Month 12
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Pediatric Quality of Life Inventory (PedsQL) 4.0 Health-related quality (HRQoL ) of life questionnaire score per dimension (self and proxy reports)
Time Frame: between Month 0 and Month 12
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between Month 0 and Month 12
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Behaviour Rating Inventory of Executive Function (BRIEF) scale scores
Time Frame: between Month 0 and Month 12
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BRIEF (8-18 years) and BRIEF-A (older than 18 years) These scales make it possible to identify executive dysfunctions that have an impact on daily life. BRIEF assesses behaviours based on questions grouped into 8 scales: inhibition, flexibility, emotional control, initiation, material organization, working memory, planning/organization, and control. For the BRIEF-A (18 years and +), 9 scales are available and those yield the same indices and general composite score. |
between Month 0 and Month 12
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Wisconsin Card Sorting Test scale score
Time Frame: between Month 0 and Month 12
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This test measures higher-order executive functioning including planning, anticipation, and cognitive flexibility.
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between Month 0 and Month 12
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Wechsler Intelligence Scale scores
Time Frame: between Month 0 and Month 12
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Scores on the main indices of the Wechsler Intelligence Scale (WISC-V for children, WAIS-IV for adults): verbal comprehension, visual-spatial abilities, working memory, fluid reasoning and processing speed.
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between Month 0 and Month 12
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NEPSY-II scale scores
Time Frame: between Month 0 and Month 12
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Score on tests of language (comprehension of instructions) and social cognition (understanding of facial emotions and theories of mind) from the NEPSY-II Child Neuropsychological Assessment battery
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between Month 0 and Month 12
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Wechsler Adult Memory Scale scores
Time Frame: between Month 0 and Month 12
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verbal and visual memory tests
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between Month 0 and Month 12
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Vineland questionnaire
Time Frame: between Month 0 and Month 12
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The Vineland-2 proxy-questionnaire of adaptive functioning: this is a parent- or other informant report on adaptive skills including social, communication, academic and daily-life independence of children.
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between Month 0 and Month 12
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Multiscore Depression Inventory for Children (MDI-C) scale score
Time Frame: between Month 0 and Month 12
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Scale providing access to the child's emotional world and more specifically to depression through 8 dimensions: self-esteem, anxiety, sad mood, social introversion, pessimism, defiance, low energy, and feelings of powerlessness.
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between Month 0 and Month 12
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Beck's Depression Inventory (BDI) scale score
Time Frame: between Month 0 and Month 12
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Self-report questionnaire (BDI-2) used to measure the characteristic attitudes and symptoms of depression
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between Month 0 and Month 12
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Revised Child Manifest Anxiety Scale (R-CMAS) score
Time Frame: between Month 0 and Month 12
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Self-administered questionnaire providing a more specific assessment of anxiety in its multiple expressions: worry/hypersensitivity, physiological anxiety, and social concern/concentration, based on a global measure of the child's or adolescent's anxiety level.
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between Month 0 and Month 12
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State-Trait Anxiety Inventory (STAI) - Form Y score
Time Frame: between Month 0 and Month 12
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between Month 0 and Month 12
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Resilience Scale score
Time Frame: between Month 0 and Month 12
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Resilience Scale for Children (RS10) score and Resilience Scale for Adults: self-administered questionnaire relating to the ability to cope and respond to life events.
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between Month 0 and Month 12
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Cardiopulmonary exercise test (CPET)
Time Frame: between Month 0 and Month 12
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between Month 0 and Month 12
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Muscular strength
Time Frame: between Month 0 and Month 12
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Muscular strength measured using a handgrip dynamometer .
This parameter represents the strength of the upper extremities and correlates with inspiratory muscle function and Vital Capacity (FVC) of the lungs.
It is measured three times on both hands while sitting with the elbows in a rectangular position.
The highest value of the better arm will be used.
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between Month 0 and Month 12
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Metabolic equivalent of task (MET)
Time Frame: between Month 0 and Month 12
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Physical activity intensity and energy expenditure measured by an actimeter
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between Month 0 and Month 12
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Following physical activity questionnaires
Time Frame: between Month 0 and Month 12
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Self-administrated questionnaire : International Physical Activity Questionnaire(IPAQ) for patients ≥15 years
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between Month 0 and Month 12
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Following physical activity questionnaires
Time Frame: between Month 0 and Month 12
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Self-administrated questionnaire : Physical Activity Questionnaire for Children (PAQ-C) for 8 to 14-year-old children
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between Month 0 and Month 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pascal AMEDRO, MD,PhD, University Hospital, Bordeaux
Publications and helpful links
General Publications
- Moreau J, Lavastre K, Romieu H, Charbonnier F, Guillaumont S, Bredy C, Abassi H, Werner O, De La Villeon G, Requirand A, Auer A, Matecki S, Karsenty C, Guitarte A, Hadeed K, Dulac Y, Souletie N, Acar P, Bajolle F, Bonnet D, Negre-Pages L, Mura T, Mounier M, Seguela PE, Thomas J, Iriart X, Jean-Benoit-Thambo, Amedro P. Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods. Int J Cardiol Heart Vasc. 2020 Mar 3;27:100489. doi: 10.1016/j.ijcha.2020.100489. eCollection 2020 Apr.
- Amedro P, Dorka R, Moniotte S, Guillaumont S, Fraisse A, Kreitmann B, Borm B, Bertet H, Barrea C, Ovaert C, Sluysmans T, De La Villeon G, Vincenti M, Voisin M, Auquier P, Picot MC. Quality of Life of Children with Congenital Heart Diseases: A Multicenter Controlled Cross-Sectional Study. Pediatr Cardiol. 2015 Dec;36(8):1588-601. doi: 10.1007/s00246-015-1201-x. Epub 2015 May 31.
- Muller J, Christov F, Schreiber C, Hess J, Hager A. Exercise capacity, quality of life, and daily activity in the long-term follow-up of patients with univentricular heart and total cavopulmonary connection. Eur Heart J. 2009 Dec;30(23):2915-20. doi: 10.1093/eurheartj/ehp305. Epub 2009 Aug 18.
- Amedro P, Picot MC, Moniotte S, Dorka R, Bertet H, Guillaumont S, Barrea C, Vincenti M, De La Villeon G, Bredy C, Soulatges C, Voisin M, Matecki S, Auquier P. Correlation between cardio-pulmonary exercise test variables and health-related quality of life among children with congenital heart diseases. Int J Cardiol. 2016 Jan 15;203:1052-60. doi: 10.1016/j.ijcard.2015.11.028. Epub 2015 Nov 10.
- Amedro P, Gavotto A, Guillaumont S, Bertet H, Vincenti M, De La Villeon G, Bredy C, Acar P, Ovaert C, Picot MC, Matecki S. Cardiopulmonary fitness in children with congenital heart diseases versus healthy children. Heart. 2018 Jun;104(12):1026-1036. doi: 10.1136/heartjnl-2017-312339. Epub 2017 Nov 23.
- Muller J, Bohm B, Semsch S, Oberhoffer R, Hess J, Hager A. Currently, children with congenital heart disease are not limited in their submaximal exercise performance. Eur J Cardiothorac Surg. 2013 Jun;43(6):1096-100. doi: 10.1093/ejcts/ezs712. Epub 2013 Jan 22.
- Calderon J, Bellinger DC, Hartigan C, Lord A, Stopp C, Wypij D, Newburger JW. Improving neurodevelopmental outcomes in children with congenital heart disease: protocol for a randomised controlled trial of working memory training. BMJ Open. 2019 Feb 19;9(2):e023304. doi: 10.1136/bmjopen-2018-023304.
- Calderon J, Angeard N, Moutier S, Plumet MH, Jambaque I, Bonnet D. Impact of prenatal diagnosis on neurocognitive outcomes in children with transposition of the great arteries. J Pediatr. 2012 Jul;161(1):94-8.e1. doi: 10.1016/j.jpeds.2011.12.036. Epub 2012 Jan 28.
- Calderon J, Stopp C, Wypij D, DeMaso DR, Rivkin M, Newburger JW, Bellinger DC. Early-Term Birth in Single-Ventricle Congenital Heart Disease After the Fontan Procedure: Neurodevelopmental and Psychiatric Outcomes. J Pediatr. 2016 Dec;179:96-103. doi: 10.1016/j.jpeds.2016.08.084. Epub 2016 Sep 28.
- Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available. Erratum In: Eur Heart J. 2021 Feb 1;42(5):548-549.
- Amedro P, Gavotto A, Legendre A, Lavastre K, Bredy C, De La Villeon G, Matecki S, Vandenberghe D, Ladeveze M, Bajolle F, Bosser G, Bouvaist H, Brosset P, Cohen L, Cohen S, Corone S, Dauphin C, Dulac Y, Hascoet S, Iriart X, Ladouceur M, Mace L, Neagu OA, Ovaert C, Picot MC, Poirette L, Sidney F, Soullier C, Thambo JB, Combes N, Bonnet D, Guillaumont S. Impact of a centre and home-based cardiac rehabilitation program on the quality of life of teenagers and young adults with congenital heart disease: The QUALI-REHAB study rationale, design and methods. Int J Cardiol. 2019 May 15;283:112-118. doi: 10.1016/j.ijcard.2018.12.050. Epub 2018 Dec 20.
- Calderon J, Wypij D, Rofeberg V, Stopp C, Roseman A, Albers D, Newburger JW, Bellinger DC. Randomized Controlled Trial of Working Memory Intervention in Congenital Heart Disease. J Pediatr. 2020 Dec;227:191-198.e3. doi: 10.1016/j.jpeds.2020.08.038. Epub 2020 Aug 19.
- Meyer M, Brudy L, Fuertes-Moure A, Hager A, Oberhoffer-Fritz R, Ewert P, Muller J. E-Health Exercise Intervention for Pediatric Patients with Congenital Heart Disease: A Randomized Controlled Trial. J Pediatr. 2021 Jun;233:163-168. doi: 10.1016/j.jpeds.2021.01.058. Epub 2021 Jan 29.
- Abassi H, Gavotto A, Picot MC, Bertet H, Matecki S, Guillaumont S, Moniotte S, Auquier P, Moreau J, Amedro P. Impaired pulmonary function and its association with clinical outcomes, exercise capacity and quality of life in children with congenital heart disease. Int J Cardiol. 2019 Jun 15;285:86-92. doi: 10.1016/j.ijcard.2019.02.069. Epub 2019 Mar 1.
- Morales Mestre N, Reychler G, Goubau C, Moniotte S. Correlation Between Cardiopulmonary Exercise Test, Spirometry, and Congenital Heart Disease Severity in Pediatric Population. Pediatr Cardiol. 2019 Apr;40(4):871-877. doi: 10.1007/s00246-019-02084-5. Epub 2019 Mar 8.
- Hager A, Hess J. Comparison of health related quality of life with cardiopulmonary exercise testing in adolescents and adults with congenital heart disease. Heart. 2005 Apr;91(4):517-20. doi: 10.1136/hrt.2003.032722.
- Muller J, Berner A, Ewert P, Hager A. Reduced health-related quality of life in older patients with congenital heart disease: a cross sectional study in 2360 patients. Int J Cardiol. 2014 Aug 1;175(2):358-62. doi: 10.1016/j.ijcard.2014.06.008. Epub 2014 Jun 18.
- Amedro P, Bajolle F, Bertet H, Cheurfi R, Lasne D, Nogue E, Auquier P, Picot MC, Bonnet D. Quality of life in children participating in a non-selective INR self-monitoring VKA-education programme. Arch Cardiovasc Dis. 2018 Mar;111(3):180-188. doi: 10.1016/j.acvd.2017.05.013. Epub 2017 Nov 1.
- Werner O, Abassi H, Lavastre K, Guillaumont S, Picot MC, Serrand C, Dulac Y, Souletie N, Acar P, Bredy C, Amedro P. Factors influencing the participation of adolescents and young adults with a congenital heart disease in a transition education program: A prospective multicentre controlled study. Patient Educ Couns. 2019 Dec;102(12):2223-2230. doi: 10.1016/j.pec.2019.06.023. Epub 2019 Jun 26.
- Abassi H, Bajolle F, Werner O, Auer A, Marquina A, Mura T, Lavastre K, Guillaumont S, Manna F, Auquier P, Bonnet D, Amedro P. Health-related quality of life correlates with time in therapeutic range in children on anticoagulants with International Normalised Ratio self-monitoring. Arch Cardiovasc Dis. 2020 Dec;113(12):811-820. doi: 10.1016/j.acvd.2020.05.022. Epub 2020 Oct 14.
- Abassi H, Huguet H, Picot MC, Vincenti M, Guillaumont S, Auer A, Werner O, De La Villeon G, Lavastre K, Gavotto A, Auquier P, Amedro P. Health-related quality of life in children with congenital heart disease aged 5 to 7 years: a multicentre controlled cross-sectional study. Health Qual Life Outcomes. 2020 Nov 12;18(1):366. doi: 10.1186/s12955-020-01615-6.
- Amedro P, Gavotto A, Bredy C, Guillaumont S. [Cardiac rehabilitation for children and adults with congenital heart disease]. Presse Med. 2017 May;46(5):530-537. doi: 10.1016/j.lpm.2016.12.001. Epub 2017 Jan 23. French.
- Calderon J, Newburger JW. Working Memory Training: A Promising Intervention? Crit Care Med. 2018 Jul;46(7):1199-1201. doi: 10.1097/CCM.0000000000003172. No abstract available.
- Amedro P, Werner O, Abassi H, Boisson A, Souilla L, Guillaumont S, Calderon J, Requirand A, Vincenti M, Pommier V, Matecki S, De La Villeon G, Lavastre K, Lacampagne A, Picot MC, Beyler C, Delclaux C, Dulac Y, Guitarte A, Charron P, Denjoy-Urbain I, Probst V, Baruteau AE, Chevalier P, Di Filippo S, Thambo JB, Bonnet D, Pasquie JL. Health-related quality of life and physical activity in children with inherited cardiac arrhythmia or inherited cardiomyopathy: the prospective multicentre controlled QUALIMYORYTHM study rationale, design and methods. Health Qual Life Outcomes. 2021 Jul 28;19(1):187. doi: 10.1186/s12955-021-01825-6.
- Gavotto A, Huguet H, Picot MC, Guillaumont S, Matecki S, Amedro P. The V̇e/V̇co2 slope: a useful tool to evaluate the physiological status of children with congenital heart disease. J Appl Physiol (1985). 2020 Nov 1;129(5):1102-1110. doi: 10.1152/japplphysiol.00520.2020. Epub 2020 Sep 10.
- Werner O, Bredy C, Lavastre K, Guillaumont S, De La Villeon G, Vincenti M, Gerl C, Dulac Y, Souletie N, Acar P, Pages L, Picot MC, Bourrel G, Oude Engberink A, Million E, Abassi H, Amedro P. Impact of a transition education program on health-related quality of life in pediatric patients with congenital heart disease: study design for a randomised controlled trial. Health Qual Life Outcomes. 2021 Jan 19;19(1):23. doi: 10.1186/s12955-021-01668-1.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2021/66
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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