ID

39478

Description

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone; ODM derived from: https://clinicaltrials.gov/show/NCT01807221

Link

https://clinicaltrials.gov/show/NCT01807221

Keywords

Versions (1)
  1. 1/15/20 1/15/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 15, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01807221

English

Eligibility Heart Failure NCT01807221

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women aged 18 years and older. the lower age limit may be higher if legally required in the participating country
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
Description

Childbearing Potential Pregnancy test negative | Childbearing Potential Sexually active Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
Description

Chronic heart failure Worsening | Requirement Emergency hospital admission | Requirement Diuretics Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C0332271
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0184673
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0012798
UMLS CUI [3,3]
C1522726
subjects with clinical diagnosis of chronic heart failure (chf) either ischemic or non ischemic, new york heart association (nyha) functional class ii-iv
Description

Chronic heart failure Ischemic New York Heart Association Classification | Chronic heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C0475224
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0264716
UMLS CUI [2,2]
C1275491
subjects with type 2 diabetes mellitus and / or
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
subjects with 30 ml/min/1.73m2 </= egfr </= 60 ml/min/1.73m2 (mdrd, modification of diet in renal disease study group) at screening
Description

eGFR | eGFR MDRD Clinical trial group

Data type

boolean

Alias
UMLS CUI [1]
C3811844
UMLS CUI [2,1]
C3811844
UMLS CUI [2,2]
C3839656
UMLS CUI [2,3]
C1320290
left ventricular ejection fraction (lvef) </= 40%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
blood potassium </= 5.0 mmol/l at screening
Description

Blood potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0729816
systolic blood pressure >/= 90 mmhg without signs and symptoms of hypotension at the screening visit
Description

Systolic Pressure | Absence Signs and Symptoms Hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0037088
UMLS CUI [2,3]
C0020649
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
Description

Heart failure de novo | Heart Disease inflammatory | Myocarditis

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0333348
UMLS CUI [3]
C0027059
acute coronary syndrome (acs) in last 30 days prior to screening
Description

Acute Coronary Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0948089
cardiogenic shock
Description

Shock, Cardiogenic

Data type

boolean

Alias
UMLS CUI [1]
C0036980
valvular heart disease requiring surgical intervention during the course of the study
Description

Heart valve disease Requirement Surgical intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0549433
stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
concomitant treatment with any mineralocorticoid receptor antagonist (mra), renin inhibitor, or potassium-sparing diuretic
Description

Mineralocorticoid Receptor Antagonists | Renin inhibitor | Potassium Sparing Diuretics

Data type

boolean

Alias
UMLS CUI [1]
C1579268
UMLS CUI [2]
C1960108
UMLS CUI [3]
C0304490
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Similar models

Eligibility Heart Failure NCT01807221

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women aged 18 years and older. the lower age limit may be higher if legally required in the participating country
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Sexually active Contraceptive methods
Item
women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Chronic heart failure Worsening | Requirement Emergency hospital admission | Requirement Diuretics Intravenous
Item
subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
boolean
C0264716 (UMLS CUI [1,1])
C0332271 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0184673 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0012798 (UMLS CUI [3,2])
C1522726 (UMLS CUI [3,3])
Chronic heart failure Ischemic New York Heart Association Classification | Chronic heart failure New York Heart Association Classification
Item
subjects with clinical diagnosis of chronic heart failure (chf) either ischemic or non ischemic, new york heart association (nyha) functional class ii-iv
boolean
C0264716 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0264716 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
subjects with type 2 diabetes mellitus and / or
boolean
C0011860 (UMLS CUI [1])
eGFR | eGFR MDRD Clinical trial group
Item
subjects with 30 ml/min/1.73m2 </= egfr </= 60 ml/min/1.73m2 (mdrd, modification of diet in renal disease study group) at screening
boolean
C3811844 (UMLS CUI [1])
C3811844 (UMLS CUI [2,1])
C3839656 (UMLS CUI [2,2])
C1320290 (UMLS CUI [2,3])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) </= 40%
boolean
C0428772 (UMLS CUI [1])
Blood potassium measurement
Item
blood potassium </= 5.0 mmol/l at screening
boolean
C0729816 (UMLS CUI [1])
Systolic Pressure | Absence Signs and Symptoms Hypotension
Item
systolic blood pressure >/= 90 mmhg without signs and symptoms of hypotension at the screening visit
boolean
C0871470 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
C0020649 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Heart failure de novo | Heart Disease inflammatory | Myocarditis
Item
acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
boolean
C0018801 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0333348 (UMLS CUI [2,2])
C0027059 (UMLS CUI [3])
Acute Coronary Syndrome
Item
acute coronary syndrome (acs) in last 30 days prior to screening
boolean
C0948089 (UMLS CUI [1])
Shock, Cardiogenic
Item
cardiogenic shock
boolean
C0036980 (UMLS CUI [1])
Heart valve disease Requirement Surgical intervention
Item
valvular heart disease requiring surgical intervention during the course of the study
boolean
C0018824 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0549433 (UMLS CUI [1,3])
Cerebrovascular accident | Transient Ischemic Attack
Item
stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Mineralocorticoid Receptor Antagonists | Renin inhibitor | Potassium Sparing Diuretics
Item
concomitant treatment with any mineralocorticoid receptor antagonist (mra), renin inhibitor, or potassium-sparing diuretic
boolean
C1579268 (UMLS CUI [1])
C1960108 (UMLS CUI [2])
C0304490 (UMLS CUI [3])
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