ID

35918

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01640964

Nyckelord

Versioner (2)
  1. 2019-04-04 2019-04-04 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

Novartis Pharmaceuticals

Uppladdad den

4 april 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Haemodynamic effect of serelaxin in patients with cirrhosis and portal hypertension NCT01640964

Engelsk

Eligibility Criteria

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion criteria study part A
Beskrivning

Inclusion criteria study part A

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0008976
UMLS CUI-3
C0449719
UMLS CUI-4
C0243032
UMLS CUI-5
C0242485
Cirrhosis with clinical and/or endoscopic evidence of portal hypertension (e.g. oesophageal varices)
Beskrivning

Patient with cirrhosis with clinical and/or endoscopic evidence of portal hypertension (e.g. oesophageal varices)

Datatyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0020541
Inclusion criteria study part B
Beskrivning

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
Cirrhosis with TIPSS in situ and a portal pressure gradient >5mmHg
Beskrivning

Patient has a cirrhosis with TIPSS in situ and a PPG higher than 5 mmHg

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0339897
UMLS CUI [1,2]
C0086138
UMLS CUI [2]
C0020541
UMLS CUI [3]
C0023890
Fully functioning TIPSS without variceal filling as confirmed by portography
Beskrivning

Patient with fully functioning tipss without variceal filling as confirmed by portography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0339897
UMLS CUI [1,2]
C0032723
UMLS CUI [1,3]
C0542341
Inclusion criteria study part A and B
Beskrivning

Inclusion criteria study part A and B

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0008976
Cirrhosis of alcohol aetiology according to physician's assessment prior to screening
Beskrivning

Patient with cirrhosis of alcohol aetiology according to physician's assessment prior to screening

Datatyp

boolean

Alias
UMLS CUI [1]
C0023891
Exclusion criteria study part A
Beskrivning

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
BMI > 40 kg/m2.
Beskrivning

BMI of patient

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Any contraindication to having an MRI scan
Beskrivning

Patient who is not able to have an MRI scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
Exclusion criteria study part B
Beskrivning

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
Contraindication to liver catheterization
Beskrivning

Patient is not able to have a liver catheterization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007430
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C1301624
Exclusion criteria study part A and B
Beskrivning

Exclusion criteria study part A and B

Alias
UMLS CUI-1
C0680251
Use of any drug to treat portal hypertension (e.g. vasodilators such as non-selective beta blockers or nitrates) within 1 month prior to screening.
Beskrivning

Drugs to treat portal hypertension used within one month prior to screening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020541
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332185
UMLS CUI [1,4]
C0087111
Decompensated cirrhosis (child-pugh score >9 points, and/or ascites requiring diuretics, and/or hepatic encephalopathy) at first visit
Beskrivning

Patient with decompensated cirrhosis defined by child-pugh score >9 points, and/or ascites requiring diuretics, and/or hepatic encephalopathy at first visit

Datatyp

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
Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
Beskrivning

Patient with any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.

Datatyp

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
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Similar models

Eligibility Criteria

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion criteria study part A
C1512693 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C0243032 (UMLS CUI-4)
C0242485 (UMLS CUI-5)
Cirrhosis with portal hypertension
Item
Cirrhosis with clinical and/or endoscopic evidence of portal hypertension (e.g. oesophageal varices)
boolean
C0023890 (UMLS CUI [1])
C0020541 (UMLS CUI [2])
Item Group
Inclusion criteria study part B
C1512693 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C0339897 (UMLS CUI-4)
C0242485 (UMLS CUI-5)
Malfunctioning TIPSS
Item
Cirrhosis with TIPSS in situ and a portal pressure gradient >5mmHg
boolean
C0339897 (UMLS CUI [1,1])
C0086138 (UMLS CUI [1,2])
C0020541 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
Fully functioning TIPSS
Item
Fully functioning TIPSS without variceal filling as confirmed by portography
boolean
C0339897 (UMLS CUI [1,1])
C0032723 (UMLS CUI [1,2])
C0542341 (UMLS CUI [1,3])
Item Group
Inclusion criteria study part A and B
C1512693 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Alcoholic liver cirrhosis
Item
Cirrhosis of alcohol aetiology according to physician's assessment prior to screening
boolean
C0023891 (UMLS CUI [1])
Item Group
Exclusion criteria study part A
C0680251 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C0243032 (UMLS CUI-4)
C0242485 (UMLS CUI-5)
BMI
Item
BMI > 40 kg/m2.
boolean
C1305855 (UMLS CUI [1])
MRI-Scan
Item
Any contraindication to having an MRI scan
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Item Group
Exclusion criteria study part B
C0680251 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C0339897 (UMLS CUI-4)
C0242485 (UMLS CUI-5)
Catheterization
Item
Contraindication to liver catheterization
boolean
C0007430 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
Item Group
Exclusion criteria study part A and B
C0680251 (UMLS CUI-1)
Drugs
Item
Use of any drug to treat portal hypertension (e.g. vasodilators such as non-selective beta blockers or nitrates) within 1 month prior to screening.
boolean
C0020541 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
State of cirrhosis
Item
Decompensated cirrhosis (child-pugh score >9 points, and/or ascites requiring diuretics, and/or hepatic encephalopathy) at first visit
boolean
C1619727 (UMLS CUI [1])
C2347612 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0003962 (UMLS CUI [4,1])
C0012798 (UMLS CUI [4,2])
C1514873 (UMLS CUI [4,3])
Non-controlled comorbidities
Item
Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
boolean
C0009488 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0543472 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
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