E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ventriculs septal defect, atrioventricular canal with pulmonary
hypertension |
Ventrikelseptumdefekt, AV-Kanal mit pulmonaler Hypertonie |
|
E.1.1.1 | Medical condition in easily understood language |
Heart defects with elevated lung vessel pressure |
Herzscheidewanddefekte mit Lungenhochdruck |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10010401 |
E.1.2 | Term | Congenital cardiovascular anomaly therapeutic procedures |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Frequency of pulmonary hypertensive crises |
Häufigkeit von Lungenhochdruckkrisen |
|
E.2.2 | Secondary objectives of the trial |
mean pulmonary artery pressure
cardiac output by transoesophageal Doppler
fluid balance
length of ventilation
length of ICU stay
|
mittlerer Pulmonalarteriendruck
Herzzeitvolumen bestimmt mit transoesophagealem Doppler
Flüssigkeitsbilanz
Beatmungsdauer
Intensivaufenthaltsdauer |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Ventricular septal defect, AV-Canal with pulmonary hypertension
informed parental consent
age 0-2 years
|
Ventrikelseptumdefekt, AV-Kanal mit pulmonaler Hypertonie
Einwilligung der Eltern
Alter 0-2 Jahre |
|
E.4 | Principal exclusion criteria |
additional structural abnormalities affecting pulmonary resistance
ventilation preoperatively
residual VSD
high dosage of catecholamines, hemodynamic instability
extracorporeal technics
abnormalities of oesophagus with contraindication for transoesophegeal
Doppler |
Widerstand beeinflussen
Beatmung präoperativ
Rest-VSD postoperativ
hoher Katecholaminbedarf und hämodynamische Instabilität
extrakorporale Verfahren wie ECMO oder Peritonealdialyse
orofaziale oder Ösophagusmißbildungen, die eine Bestimmung des HZV
mit transösophagealem Doppler ausschließen |
|
E.5 End points |
E.5.1 | Primary end point(s) |
number of pulmonary hypertensive crises |
Anzahl pulmonal hypertensiver Krisen
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
0,6,12,24,36,48 hours after admission |
0,6,12,24,36,48, Stunden nach Intensivaufnahme |
|
E.5.2 | Secondary end point(s) |
mean pulmonary pressure
fluid balance
cardiac output
duration of ventilation
duration of ICU stay
German |
mittlerer Pulmonalarteriendruck
Flüssigkeitsbilanz
Herzzeitvolumen
Beatmungsdauer
Intensivaufenthaltsdauer |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
0,6,12,24,36,48 hours after admission |
0,6,12,24,36,48, Stunden nach Intensivaufnahme |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last visit of the last subject |
letzte Visite letzter Patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |