Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 14 Years
Item
Alter mindestens 14 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Written informed consent obtained
Item
Written informed consent obtained
boolean
C0021430 (UMLS CUI 2011AA)
No participation in another AMG driven study attendancing this treatment protocol
Item
No participation in another AMG driven study attendancing this treatment protocol
boolean
C1518422 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C2827364 (UMLS CUI 2011AA)
C2348563 (UMLS CUI 2011AA)
Presence of cyanosis with < 93 % arterial oxygen saturation (measured by transcutaneous pulse oximetry)
Item
Presence of cyanosis with < 93 % arterial oxygen saturation (measured by transcutaneous pulse oximetry)
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0010520 (UMLS CUI 2011AA)
119419001 (SNOMED CT 2011_0131)
10011703 (MedDRA 14.1)
R23.0 (ICD-10-CM Version 2010)
782.5 (ICD-9-CM Version 2011)
C0523807 (UMLS CUI 2011AA)
264598005 (SNOMED CT 2011_0131)
10033316 (MedDRA 14.1)
C0034108 (UMLS CUI 2011AA)
252465000 (SNOMED CT 2011_0131)
10060209 (MedDRA 14.1)
Clinical indication for the invasive diagnostic procedures planned for the study is given. This is evaluated on the basis of observation before, during and after medicinal therapy)
Item
Clinical indication for the invasive diagnostic procedures planned for the study is given. This is evaluated on the basis of observation before, during and after medicinal therapy)
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
CL335836 (UMLS CUI 2011AA)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0430022 (UMLS CUI 2011AA)
103693007 (SNOMED CT 2011_0131)
10061816 (MedDRA 14.1)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0220825 (UMLS CUI 2011AA)
CL370598 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Presence of PAH as diagnosed by invasive methods with Rp:Rs > 0.5 measured at rest, before testing of pulmonary vasodilatory reserve
Item
Presence of PAH as diagnosed by invasive methods with Rp:Rs > 0.5 measured at rest, before testing of pulmonary vasodilatory reserve
boolean
C0152171 (UMLS CUI 2011AA)
26174007 (SNOMED CT 2011_0131)
10036727 (MedDRA 14.1)
I27.0 (ICD-10-CM Version 2010)
416.0 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0025663 (UMLS CUI 2011AA)
260686004 (SNOMED CT 2011_0131)
MTHU024654 (LOINC Version 232)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C0039593 (UMLS CUI 2011AA)
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C0042401 (UMLS CUI 2011AA)
30017007 (SNOMED CT 2011_0131)
10047142 (MedDRA 14.1)
C2347957 (UMLS CUI 2011AA)
One of the following diagnoses:
Item
Diagnose
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
non-corrected large congenital shunting defect at atrial, ventricular or arterial level:
Item
non-corrected large congenital shunting defect at atrial, ventricular or arterial level:
boolean
C1518422 (UMLS CUI 2011AA)
C1947976 (UMLS CUI 2011AA)
C0549177 (UMLS CUI 2011AA)
255509001 (SNOMED CT 2011_0131)
C0009678 (UMLS CUI 2011AA)
C0232350 (UMLS CUI 2011AA)
72884006 (SNOMED CT 2011_0131)
10052664 (MedDRA 14.1)
C1457869 (UMLS CUI 2011AA)
6920004 (SNOMED CT 2011_0131)
PAPVD
Item
Partial anomalous pulmonary venous drainage, Partial Anomalous Pulmonary Venous Return
boolean
C0158634 (UMLS CUI 2011AA)
68237008 (SNOMED CT 2011_0131)
10034056 (MedDRA 14.1)
Q26.3 (ICD-10-CM Version 2010)
747.42 (ICD-9-CM Version 2011)
ASD
Item
Vorhofseptumdefekt, ASD
boolean
C0018817 (UMLS CUI 2011AA)
70142008 (SNOMED CT 2011_0131)
10003664 (MedDRA 14.1)
Q21.1 (ICD-10-CM Version 2010)
SVD
Item
Atrial Septal Defect Sinus Venosus, Sinus venosus atrial septal defect
boolean
C0344730 (UMLS CUI 2011AA)
95268002 (SNOMED CT 2011_0131)
VSD
Item
Ventrikelseptumdefekt, VSD, Herzkammerscheidewanddefekt
boolean
C0018818 (UMLS CUI 2011AA)
30288003 (SNOMED CT 2011_0131)
10047298 (MedDRA 14.1)
Q21.0 (ICD-10-CM Version 2010)
745.4 (ICD-9-CM Version 2011)
AVSD
Item
Atrioventricular septal defect, Atrioventricular septal defect and common atrioventricular junction
boolean
C0344783 (UMLS CUI 2011AA)
253414002 (SNOMED CT 2011_0131)
10063836 (MedDRA 14.1)
Q21.2 (ICD-10-CM Version 2010)
TAC
Item
TAC
boolean
C0205106 (UMLS CUI 2011AA)
62824007 (SNOMED CT 2011_0131)
C0597891 (UMLS CUI 2011AA)
APW
Item
Aortopulmonary window, Aortopulmonary septal defect
boolean
C0003516 (UMLS CUI 2011AA)
17024001 (SNOMED CT 2011_0131)
10063732 (MedDRA 14.1)
Q21.4 (ICD-10-CM Version 2010)
PDA
Item
Ductus arteriosus apertus persistens
boolean
C0013274 (UMLS CUI 2011AA)
83330001 (SNOMED CT 2011_0131)
10034130 (MedDRA 14.1)
Q25.0 (ICD-10-CM Version 2010)
747.0 (ICD-9-CM Version 2011)
combinations thereof
Item
combinations thereof
boolean
C1947911 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Surgically corrected shunting defect (diagnoses as above) with significant residual defect
Item
Surgically corrected shunting defect (diagnoses as above) with significant residual defect
boolean
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C1947976 (UMLS CUI 2011AA)
C0232350 (UMLS CUI 2011AA)
72884006 (SNOMED CT 2011_0131)
10052664 (MedDRA 14.1)
C1457869 (UMLS CUI 2011AA)
6920004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C1609982 (UMLS CUI 2011AA)
65320000 (SNOMED CT 2011_0131)
C1457869 (UMLS CUI 2011AA)
6920004 (SNOMED CT 2011_0131)
Other diagnoses with univentricular physiology/ hemodynamics.
Item
Other diagnoses with univentricular physiology/ hemodynamics.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0031843 (UMLS CUI 2011AA)
C0019010 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
pregnancy or lactation
Item
pregnancy or lactation
boolean
women of child-bearing age who are sexually active without practising highly effective methods of contraception
Item
women of child-bearing age who are sexually active without practising highly effective methods of contraception
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C1148523 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
any diseases or impairment that, in the opinion of the investigator exclude a subject from participation
Item
any diseases or impairment that, in the opinion of the investigator exclude a subject from participation
boolean
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
CL425201 (UMLS CUI 2011AA)
C0681850 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
Substance abuse
Item
substance abuse (alcohol, medicines, drugs)
boolean
C0740858 (UMLS CUI-1)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
417928002 (SNOMED CT 2011_0131)
10000341 (MedDRA 14.1)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
Item
other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
boolean
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0205486 (UMLS CUI 2011AA)
60224009 (SNOMED CT 2011_0131)
C0683578 (UMLS CUI 2011AA)
C0851364 (UMLS CUI 2011AA)
10041244 (MedDRA 14.1)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
insufficient compliance
Item
insufficient compliance
boolean
C1321605 (UMLS CUI 2011AA)
missing willingness to storaging and transferring pseudonymous disease data within this study.
Item
missing willingness to storaging and transferring pseudonymous disease data within this study.
boolean
C1705492 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1698986 (UMLS CUI 2011AA)
440276004 (SNOMED CT 2011_0131)
STORE (HL7 V3 2006_05)
C1705822 (UMLS CUI 2011AA)
MTHU034962 (LOINC Version 232)
C0033824 (UMLS CUI 2011AA)
P (HL7 V3 2006_05)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0681873 (UMLS CUI 2011AA)
subjects who are not able to perform Cardio-Pulmonary Exercise Testing (CPX).
Item
subjects who are not able to perform Cardio-Pulmonary Exercise Testing (CPX).
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C2959886 (UMLS CUI 2011AA)
447346005 (SNOMED CT 2011_0131)
pulmonary hypertension secondary to any etiology other than those specified in the inclusion criteria
Item
pulmonary hypertension secondary to any etiology other than those specified in the inclusion criteria
boolean
C0020542 (UMLS CUI 2011AA)
70995007 (SNOMED CT 2011_0131)
10037400 (MedDRA 14.1)
I27.2 (ICD-10-CM Version 2010)
E13539 (ICD-9-CM Version 2011)
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0205369 (UMLS CUI 2011AA)
69658003 (SNOMED CT 2011_0131)
CL425202 (UMLS CUI 2011AA)
subjects with known intolerance of NO and iloprost or their constituents
Item
subjects with known intolerance of NO and iloprost or their constituents
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
CL415164 (UMLS CUI 2011AA)
OINT (HL7 V3 2006_05)
C0028128 (UMLS CUI 2011AA)
6710000 (SNOMED CT 2011_0131)
C0079594 (UMLS CUI 2011AA)
395740002 (SNOMED CT 2011_0131)
C0729650 (UMLS CUI 2011AA)
312297002 (SNOMED CT 2011_0131)
acute decompensated heart failure within the 7 days before the invasive diagnostic procedure
Item
acute decompensated heart failure within the 7 days before the invasive diagnostic procedure
boolean
C1609524 (UMLS CUI 2011AA)
10064653 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0430022 (UMLS CUI 2011AA)
103693007 (SNOMED CT 2011_0131)
10061816 (MedDRA 14.1)
clinically significant haemoptysis within the last 6 months
Item
clinically significant haemoptysis within the last 6 months
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0019079 (UMLS CUI 2011AA)
66857006 (SNOMED CT 2011_0131)
10018964 (MedDRA 14.1)
R04.2 (ICD-10-CM Version 2010)
786.3 (ICD-9-CM Version 2011)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
hemodynamic instability which would represent an unjustifiable risk during testing of pulmonary arterial vasoreagibility
Item
hemodynamic instability which would represent an unjustifiable risk during testing of pulmonary arterial vasoreagibility
boolean
C0948268 (UMLS CUI 2011AA)
422773005 (SNOMED CT 2011_0131)
10052076 (MedDRA 14.1)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0039593 (UMLS CUI 2011AA)
C0034052 (UMLS CUI 2011AA)
81040000 (SNOMED CT 2011_0131)
MTHU012075 (LOINC Version 232)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0443286 (UMLS CUI 2011AA)
263851003 (SNOMED CT 2011_0131)
MTHU014636 (LOINC Version 232)
arterial hypotension (as defined by age-specific values)
Item
arterial hypotension (as defined by age-specific values)
boolean
C0020649 (UMLS CUI 2011AA)
45007003 (SNOMED CT 2011_0131)
10003146 (MedDRA 14.1)
I95 (ICD-10-CM Version 2010)
458 (ICD-9-CM Version 2011)
C1704788 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C1552740 (UMLS CUI 2011AA)
INSTANCE (HL7 V3 2006_05)
C1522609 (UMLS CUI 2011AA)
anemia (Hb < 10 g/dl)
Item
Anämie
boolean
C0002871 (UMLS CUI 2011AA)
271737000 (SNOMED CT 2011_0131)
10002034 (MedDRA 14.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE 1105E)
decompensated symptomatic policythemia; (details: 4.2.2. exclusion criteria)
Item
decompensated symptomatic policythemia; (details: 4.2.2. exclusion criteria)
boolean
C0205434 (UMLS CUI 2011AA)
5650002 (SNOMED CT 2011_0131)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0032461 (UMLS CUI 2011AA)
127062003 (SNOMED CT 2011_0131)
10036051 (MedDRA 14.1)
D75.1 (ICD-10-CM Version 2010)
thrombocytopenia (< 50.000/µl)
Item
Thrombocytopenia
boolean
C0040034 (UMLS CUI 2011AA)
302215000 (SNOMED CT 2011_0131)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE 1105E)
secondary impairment of organic function:
Item
secondary impairment of organic function:
boolean
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0678852 (UMLS CUI 2011AA)
impairment of renal function (GFR < 30 ml/min/1,73 m2 BSA)
Item
impairment of renal function (GFR < 30 ml/min/1,73 m2 BSA)
boolean
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
C0005902 (UMLS CUI 2011AA)
128178001 (SNOMED CT 2011_0131)
10050311 (MedDRA 14.1)
impairment of hepatic function (ALT and/or AST > 3 x ULN and bilirubin ≥ 2 mg/dl)
Item
impairment of hepatic function (ALT and/or AST > 3 x ULN and bilirubin ≥ 2 mg/dl)
boolean
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
10003543 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
other sources of pulmonary blood flow which prohibit measurement of the blood flow into the lungs and therefore of the pulmonary vascular resistance:
Item
other sources of pulmonary blood flow which prohibit measurement of the blood flow into the lungs and therefore of the pulmonary vascular resistance:
boolean
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C0005775 (UMLS CUI 2011AA)
58190003 (SNOMED CT 2011_0131)
C0683610 (UMLS CUI 2011AA)
C0242485 (UMLS CUI 2011AA)
122869004 (SNOMED CT 2011_0131)
MTHU003137 (LOINC Version 232)
C0005775 (UMLS CUI 2011AA)
58190003 (SNOMED CT 2011_0131)
C0024109 (UMLS CUI 2011AA)
39607008 (SNOMED CT 2011_0131)
MTHU008683 (LOINC Version 232)
C0456261 (UMLS CUI 2011AA)
276901002 (SNOMED CT 2011_0131)
Glenn
Item
Glenn shunt, Anastomosis of superior vena cava to pulmonary artery
boolean
C0190763 (UMLS CUI 2011AA)
175249005 (SNOMED CT 2011_0131)
39.21 (ICD-9-CM Version 2011)
BT shunt
Item
BT - Blalock-Taussig shunt, Subclavian to pulmonary artery shunt operation
boolean
C0397553 (UMLS CUI 2011AA)
13662000 (SNOMED CT 2011_0131)
10069411 (MedDRA 14.1)
significant number of MAPCAs; (details: 4.2.2. exclusion criteria)
Item
significant number of MAPCAs; (details: 4.2.2. exclusion criteria)
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0237753 (UMLS CUI 2011AA)
260299005 (SNOMED CT 2011_0131)
MTHU024869 (LOINC Version 232)
C0431506 (UMLS CUI 2011AA)
253689007 (SNOMED CT 2011_0131)
10064207 (MedDRA 14.1)
Obstruction of pulmonary blood outflow:
Item
Obstruction of pulmonary outflow tract
boolean
CL431203 (UMLS CUI 2011AA)
449120006 (SNOMED CT 2011_0131)
obstruction of pulmonary venous return
Item
obstruction of pulmonary venous return
boolean
C0028778 (UMLS CUI 2011AA)
26036001 (SNOMED CT 2011_0131)
10061876 (MedDRA 14.1)
C0034090 (UMLS CUI 2011AA)
122972007 (SNOMED CT 2011_0131)
MTHU003054 (LOINC Version 232)
C1388021 (UMLS CUI 2011AA)
mitral valve dysfunction
Item
mitral valve dysfunction
boolean
C0026264 (UMLS CUI 2011AA)
91134007 (SNOMED CT 2011_0131)
MTHU002664 (LOINC Version 232)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
Left heart diseases:
Item
Left heart diseases:
boolean
C0225809 (UMLS CUI 2011AA)
17398003 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
aortic or mitral valve disease (more severe than "mild")
Item
aortic or mitral valve disease (more severe than "mild")
boolean
C1260873 (UMLS CUI 2011AA)
8722008 (SNOMED CT 2011_0131)
10061589 (MedDRA 14.1)
424.1 (ICD-9-CM Version 2011)
E10071 (CTCAE 1105E)
C0026264 (UMLS CUI 2011AA)
91134007 (SNOMED CT 2011_0131)
MTHU002664 (LOINC Version 232)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
restrictive or congestive cardiomyopathy
Item
restrictive or congestive cardiomyopathy
boolean
C0007196 (UMLS CUI 2011AA)
90828009 (SNOMED CT 2011_0131)
10038748 (MedDRA 14.1)
E10192 (CTCAE 1105E)
C0007193 (UMLS CUI 2011AA)
399020009 (SNOMED CT 2011_0131)
10056370 (MedDRA 14.1)
I42.0 (ICD-10-CM Version 2010)
PCWP/LVEDP > 15 mmHg
Item
PCWP/LVEDP > 15 mmHg
boolean
C0034094 (UMLS CUI 2011AA)
118433006 (SNOMED CT 2011_0131)
10037325 (MedDRA 14.1)
C0456190 (UMLS CUI 2011AA)
276781007 (SNOMED CT 2011_0131)
symptomatic coronary artery disease
Item
symptomatic coronary artery disease
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
Significant valvular diseases other than tricuspid or pulmonary regurgitation (these are not exclusion criteria; details: 4.2.2. exclusion criteria).
Item
Significant valvular diseases other than tricuspid or pulmonary regurgitation (these are not exclusion criteria; details: 4.2.2. exclusion criteria).
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0026265 (UMLS CUI 2011AA)
11851006 (SNOMED CT 2011_0131)
10061532 (MedDRA 14.1)
424.0 (ICD-9-CM Version 2011)
E10134 (CTCAE 1105E)
CL411789 (UMLS CUI 2011AA)
CL354298 (UMLS CUI 2011AA)
10049217 (MedDRA 14.1)
C0034088 (UMLS CUI 2011AA)
91434003 (SNOMED CT 2011_0131)
10037448 (MedDRA 14.1)
Pericardial constriction
Item
PERICARDIAL CONSTRICTION
boolean
C0240709 (UMLS CUI 2011AA)
History of stroke, myocardial infarction or life-threatening arrhythmia within the 6 months before screening
Item
History of stroke, myocardial infarction or life-threatening arrhythmia within the 6 months before screening
boolean
C1275835 (UMLS CUI 2011AA)
399211009 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C1610642 (UMLS CUI 2011AA)
440181000 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Bronchopulmonary dysplasia (BPD) and other chronic lung diseases
Item
Bronchopulmonary dysplasia (BPD) and other chronic lung diseases
boolean
C0006287 (UMLS CUI 2011AA)
67569000 (SNOMED CT 2011_0131)
10006475 (MedDRA 14.1)
P27.8 (ICD-10-CM Version 2010)
C0746102 (UMLS CUI 2011AA)
413839001 (SNOMED CT 2011_0131)
History of significant pulmonary embolism
Item
History of significant pulmonary embolism
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0034065 (UMLS CUI 2011AA)
59282003 (SNOMED CT 2011_0131)
10037377 (MedDRA 14.1)
I26 (ICD-10-CM Version 2010)
415.1 (ICD-9-CM Version 2011)
Other relevant diseases (e.g. HIV, diabetes mellitus requiring medical treatment)
Item
Other relevant diseases (e.g. HIV, diabetes mellitus requiring medical treatment)
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0418981 (UMLS CUI 2011AA)
243121000 (SNOMED CT 2011_0131)
Subjects with trisomy 21 (reproducibility of 6-MWT and CPX doubtful; communication as to side effects and subjective quality of life doubtful)
Item
Subjects with trisomy 21 (reproducibility of 6-MWT and CPX doubtful; communication as to side effects and subjective quality of life doubtful)
boolean
CL333417 (UMLS CUI 2011AA)
C0750558 (UMLS CUI 2011AA)
C0035149 (UMLS CUI 2011AA)
C0430515 (UMLS CUI 2011AA)
252478000 (SNOMED CT 2011_0131)
C2959886 (UMLS CUI 2011AA)
447346005 (SNOMED CT 2011_0131)
C0750558 (UMLS CUI 2011AA)
C0009452 (UMLS CUI 2011AA)
263536004 (SNOMED CT 2011_0131)
MTHU021752 (LOINC Version 232)
C0879626 (UMLS CUI 2011AA)
281647001 (SNOMED CT 2011_0131)
10067484 (MedDRA 14.1)
C0439655 (UMLS CUI 2011AA)
255362007 (SNOMED CT 2011_0131)
MTHU036449 (LOINC Version 232)
C0518214 (UMLS CUI 2011AA)
405152002 (SNOMED CT 2011_0131)
all contraindications against the study medication (see also "4.2.3 concomitant medication")
Item
all contraindications against the study medication (see also "4.2.3 concomitant medication")
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
hypersensitivity against the active ingredients as well as supplementaries
Item
hypersensitivity against the active ingredients as well as supplementaries
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1372955 (UMLS CUI 2011AA)
ACTI (HL7 V3 2006_05)
C2348609 (UMLS CUI 2011AA)
C1254351 (UMLS CUI 2011AA)
patients who lost vision on one eye due to a non arteriitic anterior ischaemic neuropathy of the opticus (NAION).
Item
patients who lost vision on one eye due to a non arteriitic anterior ischaemic neuropathy of the opticus (NAION).
boolean
CL355222 (UMLS CUI 2011AA)
CL420107 (UMLS CUI 2011AA)
C1852242 (UMLS CUI 2011AA)
10068245 (MedDRA 14.1)
Prohibited concomitant medication:
Item
Prohibited concomitant medication:
boolean
C0683610 (UMLS CUI 2011AA)
C2347852 (UMLS CUI 2011AA)
Any medication listed below which has not been discontinued at least 30 days prior to screening. Specific pulmonary vasodilators during cardiac catheterization are allowed.
Item
Any medication listed below which has not been discontinued at least 30 days prior to screening. Specific pulmonary vasodilators during cardiac catheterization are allowed.
boolean
C0013227 (UMLS CUI 2011AA)
C0745732 (UMLS CUI 2011AA)
CL384716 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1524004 (UMLS CUI 2011AA)
C1552740 (UMLS CUI 2011AA)
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C0042402 (UMLS CUI 2011AA)
58944007 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0018795 (UMLS CUI 2011AA)
41976001 (SNOMED CT 2011_0131)
10007815 (MedDRA 14.1)
37.21 (ICD-9-CM Version 2011)
Unspecified concomitant medication
Item
Unspecified concomitant medication
boolean
C0205370 (UMLS CUI 2011AA)
10003008 (SNOMED CT 2011_0131)
C2347852 (UMLS CUI 2011AA)
Other significant medication (a.o. chronic intake of systemic immunosuppression as e.g. systemic glucocorticoids, cytostatic drugs, ciclosporin)
Item
Other significant medication (a.o. chronic intake of systemic immunosuppression as e.g. systemic glucocorticoids, cytostatic drugs, ciclosporin)
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0017710 (UMLS CUI 2011AA)
419933005 (SNOMED CT 2011_0131)
C0010858 (UMLS CUI 2011AA)
373221003 (SNOMED CT 2011_0131)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
Instable medication (details: 4.2.5 prohibited concomitant medication):
Item
Instable medication (details: 4.2.5 prohibited concomitant medication):
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
begin of a new medication regimen within the last 30 days before screening
Item
begin of a new medication regimen within the last 30 days before screening
boolean
CL414705 (UMLS CUI 2011AA)
C0205314 (UMLS CUI 2011AA)
7147002 (SNOMED CT 2011_0131)
C1829817 (UMLS CUI 2011AA)
MTHU013187 (LOINC Version 232)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
change in the dosage of existing medication within the last 7 days before cardiac catheterization
Item
change in the dosage of existing medication within the last 7 days before cardiac catheterization
boolean
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0018795 (UMLS CUI 2011AA)
41976001 (SNOMED CT 2011_0131)
10007815 (MedDRA 14.1)
37.21 (ICD-9-CM Version 2011)
Existing anti-pulmonary hypertensive medication (in any form) with:
Item
Existing anti-pulmonary hypertensive medication (in any form) with:
boolean
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
PDE-5 antagonists (e.g. sildenafil)
Item
PDE-5 antagonists (e.g. sildenafil)
boolean
C0757672 (UMLS CUI 2011AA)
C0243076 (UMLS CUI 2011AA)
C2923059 (UMLS CUI 2011AA)
C0529793 (UMLS CUI 2011AA)
372572000 (SNOMED CT 2011_0131)
prostanoids (e.g. iloprost, prostacyclin, beraprost) In case the patient is stable and on Bosentan therapy at least for 6 months. Bosentan (Tracleer) is unprohibited as concomitant medication.
Item
prostanoids (e.g. iloprost, prostacyclin, beraprost) In case the patient is stable and on Bosentan therapy at least for 6 months. Bosentan (Tracleer) is unprohibited as concomitant medication.
boolean
C1623719 (UMLS CUI 2011AA)
418226006 (SNOMED CT 2011_0131)
C0079594 (UMLS CUI 2011AA)
395740002 (SNOMED CT 2011_0131)
C0033567 (UMLS CUI 2011AA)
372513003 (SNOMED CT 2011_0131)
C0053336 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0252643 (UMLS CUI 2011AA)
385559004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
C0683610 (UMLS CUI 2011AA)
C0252643 (UMLS CUI 2011AA)
385559004 (SNOMED CT 2011_0131)
C2347852 (UMLS CUI 2011AA)
Other medication with vascular action:
Item
Other medication with vascular action:
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1801960 (UMLS CUI 2011AA)
CL415100 (UMLS CUI 2011AA)
alpha blockers
Item
Alpha-Blocker
boolean
C0001641 (UMLS CUI 2011AA)
373275009 (SNOMED CT 2011_0131)
L-arginin (acts through NO axis)
Item
L-arginin (acts through NO axis)
boolean
C0003765 (UMLS CUI 2011AA)
52625008 (SNOMED CT 2011_0131)
MTHU004112 (LOINC Version 232)
C0028128 (UMLS CUI 2011AA)
6710000 (SNOMED CT 2011_0131)
C1522496 (UMLS CUI 2011AA)
ritonavir, nicorandil (act through K+ channels)
Item
ritonavir, nicorandil (act through K+ channels)
boolean
C0292818 (UMLS CUI 2011AA)
386896009 (SNOMED CT 2011_0131)
MTHU013855 (LOINC Version 232)
C0068700 (UMLS CUI 2011AA)
395809002 (SNOMED CT 2011_0131)
C0597277 (UMLS CUI 2011AA)
C1706095 (UMLS CUI 2011AA)
Medication that is not compatible with sildenafil or interferes with the metabolism:
Item
Medication that is not compatible with sildenafil or interferes with the metabolism:
boolean
C0013227 (UMLS CUI 2011AA)
C0679426 (UMLS CUI 2011AA)
C0529793 (UMLS CUI 2011AA)
372572000 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0025519 (UMLS CUI 2011AA)
47722004 (SNOMED CT 2011_0131)
cytochrome P450-CYP2C9 and CYP3A4 inhibitors (e.g. erythromycin/ketoconazole/itraconazole/protease inhibitors)
Item
cytochrome P450-CYP2C9 and CYP3A4 inhibitors (e.g. erythromycin/ketoconazole/itraconazole/protease inhibitors)
boolean
C1828473 (UMLS CUI 2011AA)
422602005 (SNOMED CT 2011_0131)
C1142644 (UMLS CUI 2011AA)
422741004 (SNOMED CT 2011_0131)
C0243077 (UMLS CUI 2011AA)
C0014806 (UMLS CUI 2011AA)
30427009 (SNOMED CT 2011_0131)
MTHU003043 (LOINC Version 232)
C0022625 (UMLS CUI 2011AA)
387216007 (SNOMED CT 2011_0131)
MTHU002299 (LOINC Version 232)
C0064113 (UMLS CUI 2011AA)
387532006 (SNOMED CT 2011_0131)
MTHU002298 (LOINC Version 232)
C0033607 (UMLS CUI 2011AA)
412127001 (SNOMED CT 2011_0131)
any existing medication that, in the opinion of the investigator, may interfere with sildenafil treatment.
Item
any existing medication that, in the opinion of the investigator, may interfere with sildenafil treatment.
boolean
C0013227 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0529793 (UMLS CUI 2011AA)
372572000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
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