ID

39494

Beschreibung

Study to Assess the Safety of BAY1067197 in Stable Heart Failure Patients on Standard Therapy Including ß-blocker; ODM derived from: https://clinicaltrials.gov/show/NCT01945606

Link

https://clinicaltrials.gov/show/NCT01945606

Stichworte

Versionen (1)
  1. 18.01.20 18.01.20 -
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See clinicaltrials.gov

Hochgeladen am

18. Januar 2020

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT01945606

Englisch

Eligibility Heart Failure NCT01945606

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
stable systolic heart failure (heart failure with reduced ejection fraction, heart failure with reduced ejection fraction [hfref]; new york heart association [nyha] i-iii) in sinus rhythm with a documented ejection fraction (ef) ≤45% within the last 3 months
Beschreibung

Systolic Heart Failure Stable | Heart failure with reduced ejection fraction New York Heart Association Classification | Sinus rhythm | Cardiac ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1135191
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C4509223
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0232201
UMLS CUI [4]
C0232174
stable standard heart failure (hf) therapy including intermediate to high dose
Beschreibung

Standard therapy Stable Heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0018801
β-blocker with either ≥ 95 mg metoprolol succinate (controlled release tablet), ≥ 5mg bisoprolol (immediate release [ir] -tablet) or ≥5mg nebivolol (ir tablet) for at least 4 weeks. additional intake of angiotensin-converting enzyme (ace) inhibitors or angiotensin receptor blockers and optional aldosterone-receptor antagonists, diuretics or digitalis is allowed
Beschreibung

Adrenergic beta-1 Receptor Antagonists Dose Intermediate | Adrenergic beta-1 Receptor Antagonists High dose | Metoprolol succinate Dose | Bisoprolol Dose | Nebivolol Dose | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Aldosterone Receptor Antagonists | Diuretics | Digitalis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304516
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205103
UMLS CUI [2,1]
C0304516
UMLS CUI [2,2]
C0444956
UMLS CUI [3,1]
C0724633
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0053799
UMLS CUI [4,2]
C0178602
UMLS CUI [5,1]
C0068475
UMLS CUI [5,2]
C0178602
UMLS CUI [6]
C0003015
UMLS CUI [7]
C0521942
UMLS CUI [8]
C1579268
UMLS CUI [9]
C0012798
UMLS CUI [10]
C0304520
men or confirmed postmenopausal women (defined as being amenorrheic for longer than 2 years with an appropriate clinical profile, e.g. age appropriate and a history of vasomotor symptoms) or women without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy (documented by medical report verification). men enrolled in this study must agree to use adequate barrier birth control measures during the treatment period of the study and for 12 weeks after receiving the investigational medicinal product (imp)
Beschreibung

Gender | Postmenopausal state | Amenorrhea Duration | Age Appropriate | Vasomotor symptom | Gender Childbearing Potential Absent | Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy | Gender Barrier Contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0449238
UMLS CUI [4,1]
C0001779
UMLS CUI [4,2]
C1548787
UMLS CUI [5]
C0750152
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C3831118
UMLS CUI [6,3]
C0332197
UMLS CUI [7]
C0015787
UMLS CUI [8]
C0589114
UMLS CUI [9]
C0278321
UMLS CUI [10]
C0020699
UMLS CUI [11,1]
C0079399
UMLS CUI [11,2]
C0004764
male patients must agree not to act as sperm donor for 12 weeks after dosing
Beschreibung

Gender Sperm donation Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0871414
UMLS CUI [1,3]
C0332197
ethnicity: white
Beschreibung

Ethnicity White

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0043157
body mass index (bmi): above/equal 18.0 and below/equal 29.9 kg/m²
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
age: 18 to 75 years (inclusive) at the first screening visit
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
biventricular pacing/active cardiac resynchronization therapy (crt) device
Beschreibung

Biventricular Pacing Device | Implantation of CRT-D

Datentyp

boolean

Alias
UMLS CUI [1]
C1322649
UMLS CUI [2]
C1135480
dependency on pacemaker or implantable cardioverter-defibrillator (icd) device with pacemaker dependency (a paced ventricular rhythm > 5% of heart activity)
Beschreibung

Dependence Pacemaker | Implantable defibrillator with Pacemaker Dependence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0439857
UMLS CUI [1,2]
C0030163
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0030163
UMLS CUI [2,4]
C0439857
a history of relevant diseases of vital organs other than the heart, of the central nervous system or other organs
Beschreibung

Disease Organ Vital | Exception Heart Disease | CNS disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0442732
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0007682
known hypersensitivity to the study preparations (active substances or excipients of the preparations) or to any other β-blocker
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Excipient | Beta-blocker allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
UMLS CUI [3]
C0570882
current or history of av-block > i°
Beschreibung

Second degree atrioventricular block | Complete atrioventricular block

Datentyp

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
unstable condition, indicated by requirement of iv drug (diuretic, inotrope, etc.) or nyha iv
Beschreibung

Patient's condition unstable | Requirement Pharmaceutical Preparations Intravenous | Diuretics | Inotropic agent | New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0438114
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1522726
UMLS CUI [3]
C0012798
UMLS CUI [4]
C0304509
UMLS CUI [5]
C1275491
acute coronary syndrome (defined as unstable angina [ua], non-st elevation myocardial infarction [nstemi], st elevation myocardial infarction [stemi]) within 3 months prior to first study drug administration
Beschreibung

Acute Coronary Syndrome | Angina, Unstable | Non-ST elevation myocardial infarction | ST segment elevation myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0002965
UMLS CUI [3]
C1561921
UMLS CUI [4]
C1536220
history of asthma or chronic obstructive pulmonary disease (copd) ≥ global initiative for chronic obstructive lung disease (gold) ii and/or allergic asthma
Beschreibung

Asthma | Chronic Obstructive Airway Disease Stage | Allergic asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0024117
UMLS CUI [2,2]
C1306673
UMLS CUI [3]
C0155877
women of childbearing potential, pregnancy or breastfeeding
Beschreibung

Childbearing Potential | Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
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Ähnliche Modelle

Eligibility Heart Failure NCT01945606

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Systolic Heart Failure Stable | Heart failure with reduced ejection fraction New York Heart Association Classification | Sinus rhythm | Cardiac ejection fraction
Item
stable systolic heart failure (heart failure with reduced ejection fraction, heart failure with reduced ejection fraction [hfref]; new york heart association [nyha] i-iii) in sinus rhythm with a documented ejection fraction (ef) ≤45% within the last 3 months
boolean
C1135191 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C4509223 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0232201 (UMLS CUI [3])
C0232174 (UMLS CUI [4])
Standard therapy Stable Heart failure
Item
stable standard heart failure (hf) therapy including intermediate to high dose
boolean
C2936643 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Adrenergic beta-1 Receptor Antagonists Dose Intermediate | Adrenergic beta-1 Receptor Antagonists High dose | Metoprolol succinate Dose | Bisoprolol Dose | Nebivolol Dose | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Aldosterone Receptor Antagonists | Diuretics | Digitalis
Item
β-blocker with either ≥ 95 mg metoprolol succinate (controlled release tablet), ≥ 5mg bisoprolol (immediate release [ir] -tablet) or ≥5mg nebivolol (ir tablet) for at least 4 weeks. additional intake of angiotensin-converting enzyme (ace) inhibitors or angiotensin receptor blockers and optional aldosterone-receptor antagonists, diuretics or digitalis is allowed
boolean
C0304516 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205103 (UMLS CUI [1,3])
C0304516 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C0724633 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0053799 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0068475 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0003015 (UMLS CUI [6])
C0521942 (UMLS CUI [7])
C1579268 (UMLS CUI [8])
C0012798 (UMLS CUI [9])
C0304520 (UMLS CUI [10])
Gender | Postmenopausal state | Amenorrhea Duration | Age Appropriate | Vasomotor symptom | Gender Childbearing Potential Absent | Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy | Gender Barrier Contraception
Item
men or confirmed postmenopausal women (defined as being amenorrheic for longer than 2 years with an appropriate clinical profile, e.g. age appropriate and a history of vasomotor symptoms) or women without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy (documented by medical report verification). men enrolled in this study must agree to use adequate barrier birth control measures during the treatment period of the study and for 12 weeks after receiving the investigational medicinal product (imp)
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0002453 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4,1])
C1548787 (UMLS CUI [4,2])
C0750152 (UMLS CUI [5])
C0079399 (UMLS CUI [6,1])
C3831118 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C0015787 (UMLS CUI [7])
C0589114 (UMLS CUI [8])
C0278321 (UMLS CUI [9])
C0020699 (UMLS CUI [10])
C0079399 (UMLS CUI [11,1])
C0004764 (UMLS CUI [11,2])
Gender Sperm donation Absent
Item
male patients must agree not to act as sperm donor for 12 weeks after dosing
boolean
C0079399 (UMLS CUI [1,1])
C0871414 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Ethnicity White
Item
ethnicity: white
boolean
C0015031 (UMLS CUI [1,1])
C0043157 (UMLS CUI [1,2])
Body mass index
Item
body mass index (bmi): above/equal 18.0 and below/equal 29.9 kg/m²
boolean
C1305855 (UMLS CUI [1])
Age
Item
age: 18 to 75 years (inclusive) at the first screening visit
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Biventricular Pacing Device | Implantation of CRT-D
Item
biventricular pacing/active cardiac resynchronization therapy (crt) device
boolean
C1322649 (UMLS CUI [1])
C1135480 (UMLS CUI [2])
Dependence Pacemaker | Implantable defibrillator with Pacemaker Dependence
Item
dependency on pacemaker or implantable cardioverter-defibrillator (icd) device with pacemaker dependency (a paced ventricular rhythm > 5% of heart activity)
boolean
C0439857 (UMLS CUI [1,1])
C0030163 (UMLS CUI [1,2])
C0162589 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0030163 (UMLS CUI [2,3])
C0439857 (UMLS CUI [2,4])
Disease Organ Vital | Exception Heart Disease | CNS disorder
Item
a history of relevant diseases of vital organs other than the heart, of the central nervous system or other organs
boolean
C0012634 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0442732 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0007682 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Excipient | Beta-blocker allergy
Item
known hypersensitivity to the study preparations (active substances or excipients of the preparations) or to any other β-blocker
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0570882 (UMLS CUI [3])
Second degree atrioventricular block | Complete atrioventricular block
Item
current or history of av-block > i°
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Patient's condition unstable | Requirement Pharmaceutical Preparations Intravenous | Diuretics | Inotropic agent | New York Heart Association Classification
Item
unstable condition, indicated by requirement of iv drug (diuretic, inotrope, etc.) or nyha iv
boolean
C0438114 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
C0012798 (UMLS CUI [3])
C0304509 (UMLS CUI [4])
C1275491 (UMLS CUI [5])
Acute Coronary Syndrome | Angina, Unstable | Non-ST elevation myocardial infarction | ST segment elevation myocardial infarction
Item
acute coronary syndrome (defined as unstable angina [ua], non-st elevation myocardial infarction [nstemi], st elevation myocardial infarction [stemi]) within 3 months prior to first study drug administration
boolean
C0948089 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C1561921 (UMLS CUI [3])
C1536220 (UMLS CUI [4])
Asthma | Chronic Obstructive Airway Disease Stage | Allergic asthma
Item
history of asthma or chronic obstructive pulmonary disease (copd) ≥ global initiative for chronic obstructive lung disease (gold) ii and/or allergic asthma
boolean
C0004096 (UMLS CUI [1])
C0024117 (UMLS CUI [2,1])
C1306673 (UMLS CUI [2,2])
C0155877 (UMLS CUI [3])
Childbearing Potential | Pregnancy | Breast Feeding
Item
women of childbearing potential, pregnancy or breastfeeding
boolean
C3831118 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
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