ID
35918
Descripción
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
Palabras clave
Versiones (2)
- 4/4/19 4/4/19 -
- 20/9/21 20/9/21 -
Titular de derechos de autor
Novartis Pharmaceuticals
Subido en
4 de abril de 2019
DOI
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Licencia
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
Descripción
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
Descripción
Patient has a cirrhosis with TIPSS in situ and a PPG higher than 5 mmHg
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0339897
- UMLS CUI [1,2]
- C0086138
- UMLS CUI [2]
- C0020541
- UMLS CUI [3]
- C0023890
Descripción
Patient with fully functioning tipss without variceal filling as confirmed by portography
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0339897
- UMLS CUI [1,2]
- C0032723
- UMLS CUI [1,3]
- C0542341
Descripción
Inclusion criteria study part A and B
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0008976
Descripción
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
Descripción
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
Descripción
Exclusion criteria study part A and B
Alias
- UMLS CUI-1
- C0680251
Descripción
Drugs to treat portal hypertension used within one month prior to screening
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0020541
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0332185
- UMLS CUI [1,4]
- C0087111
Descripción
Patient with decompensated cirrhosis defined by child-pugh score >9 points, and/or ascites requiring diuretics, and/or hepatic encephalopathy at first visit
Tipo de datos
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
Descripción
Patient with any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
Tipo de datos
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])