Brief description of trial (Data source: BASEC)
Le registre TOPP-2 est un registre qui contient des données d'enfants et d'adolescents ayant récemment reçu un diagnostic d'hypertension artérielle pulmonaire provenant du monde entier, qui a pour but d’améliorer la compréhension de l'évolution de la maladie et d'obtenir des résultats à long terme sur l'hypertension artérielle pulmonaire pendant l'enfance. Les patients sont soumis à une évaluation clinique et reçoivent des soins médicaux standards déterminés par les médecins traitants en fonction de leur pratique clinique quotidienne. Le registre TOPP-2 lui-même ne nécessite aucun type de traitement et a été spécialement conçu pour vérifier les objectifs de traitement proposés et identifier les raisons de changements de traitement. Le registre a été planifié et lancé sous la direction scientifique de l’Association for Pediatric Pulmonary Hypertension (PePH) et est géré indépendamment des sponsors financiers. Le premier patient a été inscrit à l'automne 2015 et l'admission se poursuivra jusqu'à la fermeture du registre, le 31 décembre 2021. Il est prévu qu'environ 440 patients seront inscrits d’ici à la fermeture du registre.
Health conditions investigated(Data source: BASEC)
Hypertension artérielle pulmonaire
Health conditions
(Data source: WHO)
Hypertension, Pulmonary
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Aucune
Criteria for participation in trial
(Data source: BASEC)
• Le patient doit être un patient incident, c.-à-d. l'hypertension artérielle pulmonaire a été récemment diagnostiquée
• Âge au moment du diagnostic: ≥ 3 mois et <18 ans
• L'hypertension artérielle pulmonaire doit avoir été diagnostiquée par cathétérisme cardiaque
Exclusion criteria
(Data source: BASEC)
Patients du groupe 2 selon la classification clinique de NICE révisée
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Patient must be an incident patient, i.e.newly diagnosed with PH
- Age at time of diagnosis is at least 3 months and less than 18 years
- Patients must present with PH belonging to one of the following categories
- Group 1 according to updated Nice clinical classification
- Group 3 according to updated Nice clinical classification
- Group 4 according to updated Nice clinical classification
- Group 5 according to updated Nice clinical classification
- PH confirmed by heart catheterisation (HC)
- At HC, the patient must present with mean pulmonary arterial pressure (PAP) of at
least 25 mmHg at rest, a pulmonary vascular resistance index (PVRi) equal to or below
3 Wood units*m^2 and mean pulmonary arterial wedge pressure (PAWP) below or equal to
15 mmHg
- In case of congenital heart disease (CHD) patients who had undergone palliative
procedure or repair to close systemic to pulmonary shunt, the diagnosis of PH must
have been confirmed by HC at least 6 months after surgery/palliative procedure took
place
- For patients with PAH-CHD open shunt, only those considered not operable due to
advanced pulmonary vascular disease are eligible
- Patients to be included into the registry, and/or their legal guardians, must give
informed consent. Where applicable patients will be asked for their written assent
- Participating sites must agree to adhere to the recommendations of the WSPH 2015 Nice,
Pediatric Taskforce.
Exclusion Criteria:
- Patients belonging to Group 2 according to updated Nice clinical classification
-
Further information on trial
Date trial registered
Nov 10, 2015
Incorporation of the first participant
Aug 1, 2015
Recruitment status
Recruiting
Academic title
(Data source: WHO)
Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension
Type of trial
(Data source: WHO)
Observational [Patient Registry]
Phase
(Data source: WHO)
Phase 2
Primary end point
(Data source: WHO)
Death;Transplantation;Adverse events
Secundary end point
(Data source: WHO)
Increase in N-terminal-proBNP (NT-proBNP);Increase in Brain Natriuretic Peptide (BNP);Worsening of echocardiographic parameters (ECHO);Decline in Panama functional class;Decline in WHO functional class;Reasons for treatment change;Escalation of treatment;Switch in treatment;Type of treatment;Decline in 6-minute walk test (6MWT);Time to clinical worsening;Potts shunt;Atrial septostomy;Use/initiation of i.v./s.c. prostanoids;Hospitalisation related to pulmonary arterial hypertension (PAH)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Geneva, Zurich
Countries
(Data source: WHO)
Australia, Brazil, Canada, China, Colombia, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Saudi Arabia, Sweden, Switzerland, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Bernhard Simonetti
+ 41 (0)41 379 7970
Contact for general information
(Data source: WHO)
Dunbar Ivy, Prof;Fabrizio Canonaco, Dr
Association for Pediatric Pulmonary Hypertension
fabrizio.canonaco@peph-association.org
Contact for scientific information
(Data source: WHO)
Dunbar Ivy, Prof;Fabrizio Canonaco, Dr
Association for Pediatric Pulmonary Hypertension
fabrizio.canonaco@peph-association.org
Further trial identification numbers
Secondary ID (Data source: WHO)
TOPP-2
Back to overview
