Last reviewed · How we verify
NCT03999320: SOPHRO CARE
Sophrology and Congenital Heart Disease
NA trial testing Sophrology sessions in Congenital Heart Disease in 200 participants. Completed in 19 September 2023.
19 September 2023
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 200 |
| Start date | 19 July 2019 |
| Primary completion | 19 September 2023 |
| Estimated completion | 19 September 2023 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Sophrology sessions
- usual care
Conditions studied
- Congenital Heart Disease — all drugs for Congenital Heart Disease →
Sponsor
University Hospital, Montpellier
Who can join
Adults 13 to 25, any sex, with Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The SOPHRO-CARE trial aims to measure the impact of sophrology on exercise capacity of adolescents and young adults with congenital heart disease. Investigator hypothesized that a series of group sessions of sophrology may improve the exercise capacity, in this population.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
The molecular mechanisms of cardiac development and related diseases.
Li Y, Du J, Deng S, Liu B, et al · · 2024 · cited 53× · PMID 39715759 · DOI 10.1038/s41392-024-02069-8 -
Physical activity interventions for people with congenital heart disease.
Williams CA, Wadey C, Pieles G, Stuart G, et al · · 2020 · cited 40× · PMID 33112424 · DOI 10.1002/14651858.cd013400.pub2 -
Impact of COVID-19 disease on clinical research in pediatric and congenital cardiology.
Pommier V, Abassi H, Lavastre K, Calderon J, et al · · 2022 · cited 3× · PMID 35523633 · DOI 10.1016/j.arcped.2022.03.004 -
Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods.
Moreau J, Lavastre K, Romieu H, Charbonnier F, et al · · 2020 · cited 2× · PMID 32154361 · DOI 10.1016/j.ijcha.2020.100489 -
Remote Sophrology in Congenital Heart Disease: The SOPHROCARE Randomized Controlled Trial.
Moreau J, Neyraud C, Huguet H, Andrianoely M, et al · · 2026 · PMID 42052946 · DOI 10.1093/eurjcn/zvag115
Verify or expand the search:
- PubMed search for NCT03999320
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Congenital Heart Disease
Currently open trials in the same condition.
- NCT07193719 — Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children · Phase 1, PHASE2 · recruiting
- NCT07023367 — Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents · NA · recruiting
- NCT06833320 — Propranolol Treatment for Postoperative Chylothorax · Phase 1, PHASE2 · recruiting
- NCT06668389 — Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary · Phase 4 · recruiting
- NCT06872320 — The Influence of Probiotics on Metabolome and Heart Rate Variability in Heart Failure of Structure Heart Disease · NA · active not recruiting
Other University Hospital, Montpellier trials
Trials by the same sponsor.
- NCT07524127 — Phenotyping of Type 2 Inflammation Profile by Rheology of Nasal Secretions and Tissue Quantification of Eosinophilic Pol · NA · not yet recruiting
- NCT07255495 — Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism · NA · not yet recruiting
- NCT07534189 — Prospective Cohort Study Evaluating a Thermal Spa Programme in Symptomatic Knee Osteoarthritis · NA · not yet recruiting
- NCT07515638 — Immun4Cure Cohort of Autoimmune Diseases · not yet recruiting
- NCT07406516 — Identification of Kinematic Variables Specific of Patellar Tendinopathy in Athletes at Risk · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03999320 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 3 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03999320.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing