ID
35918
Beschrijving
The main purpose of this exploratory study was to investigate the effect of serelaxin (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis and portal hypertension. Measurements were acquired non-invasively using magnetic resonance angiography (MRA) (study part A) and more directly via cannulation of the hepatic portal vein during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check procedure (study part B), to determine the acute haemodynamic response to serelaxin (RLX030). ODM derived from: https://clinicaltrials.gov/show/NCT01640964
Link
https://clinicaltrials.gov/show/NCT01640964
Trefwoorden
Versies (2)
- 04-04-19 04-04-19 -
- 20-09-21 20-09-21 -
Houder van rechten
Novartis Pharmaceuticals
Geüploaded op
4 april 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Haemodynamic effect of serelaxin in patients with cirrhosis and portal hypertension NCT01640964
Eligibility Criteria
- StudyEvent: Eligibility
Beschrijving
Inclusion criteria study part B
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0449719
- UMLS CUI-4
- C0339897
- UMLS CUI-5
- C0242485
Beschrijving
Patient has a cirrhosis with TIPSS in situ and a PPG higher than 5 mmHg
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0339897
- UMLS CUI [1,2]
- C0086138
- UMLS CUI [2]
- C0020541
- UMLS CUI [3]
- C0023890
Beschrijving
Patient with fully functioning tipss without variceal filling as confirmed by portography
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0339897
- UMLS CUI [1,2]
- C0032723
- UMLS CUI [1,3]
- C0542341
Beschrijving
Inclusion criteria study part A and B
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0008976
Beschrijving
Exclusion criteria study part A
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0449719
- UMLS CUI-4
- C0243032
- UMLS CUI-5
- C0242485
Beschrijving
Exclusion criteria study part B
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0449719
- UMLS CUI-4
- C0339897
- UMLS CUI-5
- C0242485
Beschrijving
Exclusion criteria study part A and B
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Drugs to treat portal hypertension used within one month prior to screening
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020541
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0332185
- UMLS CUI [1,4]
- C0087111
Beschrijving
Patient with decompensated cirrhosis defined by child-pugh score >9 points, and/or ascites requiring diuretics, and/or hepatic encephalopathy at first visit
Datatype
boolean
Alias
- UMLS CUI [1]
- C1619727
- UMLS CUI [2]
- C2347612
- UMLS CUI [3]
- C0019151
- UMLS CUI [4,1]
- C0003962
- UMLS CUI [4,2]
- C0012798
- UMLS CUI [4,3]
- C1514873
Beschrijving
Patient with any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0035647
- UMLS CUI [2,1]
- C0009488
- UMLS CUI [2,2]
- C0543472
- UMLS CUI [2,3]
- C0392760
Similar models
Eligibility Criteria
- StudyEvent: Eligibility
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C0243032 (UMLS CUI-4)
C0242485 (UMLS CUI-5)
C0020541 (UMLS CUI [2])
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C0339897 (UMLS CUI-4)
C0242485 (UMLS CUI-5)
C0086138 (UMLS CUI [1,2])
C0020541 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0032723 (UMLS CUI [1,2])
C0542341 (UMLS CUI [1,3])
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C0243032 (UMLS CUI-4)
C0242485 (UMLS CUI-5)
C0024485 (UMLS CUI [1,2])
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C0339897 (UMLS CUI-4)
C0242485 (UMLS CUI-5)
C0023884 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C2347612 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0003962 (UMLS CUI [4,1])
C0012798 (UMLS CUI [4,2])
C1514873 (UMLS CUI [4,3])
C0035647 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0543472 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])