ID

35918

Description

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

Keywords

Versions (2)
  1. 4/4/19 4/4/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

Novartis Pharmaceuticals

Uploaded on

April 4, 2019

DOI

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License

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

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion criteria study part A
Description

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)
Description

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

Data type

boolean

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

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
Description

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

Data type

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
Description

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

Data type

boolean

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

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
Description

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

Data type

boolean

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

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.
Description

BMI of patient

Data type

boolean

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

Patient who is not able to have an MRI scan

Data type

boolean

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

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
Description

Patient is not able to have a liver catheterization

Data type

boolean

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

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.
Description

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

Data type

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
Description

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

Data type

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.
Description

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

Data type

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 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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