ID

40353

Beschreibung

BRAVE Study With Uncontrolled Essential Hypertension (BRAVE Study); ODM derived from: https://clinicaltrials.gov/show/NCT02398929

Link

https://clinicaltrials.gov/show/NCT02398929

Stichworte

Versionen (1)
  1. 11.04.20 11.04.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. April 2020

DOI

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Eligibility Hypertension NCT02398929

Englisch

Eligibility Hypertension NCT02398929

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with essential hypertension
Beschreibung

Essential Hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0085580
for uncomplicated hypertensive patients on no antihypertensive treatment, sitting clinic systolic blood pressure of 140-169 mmhg and / or a sitting clinic diastolic blood pressure of 90-109 mmhg.
Beschreibung

Patients Hypertensive Uncomplicated | Antihypertensive therapy Absent | Sitting systolic blood pressure | Sitting diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0857121
UMLS CUI [1,3]
C0443334
UMLS CUI [2,1]
C0585941
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C1319893
UMLS CUI [4]
C1319894
for patients with diabetes mellitus or with chronic kidney disease, sitting clinic systolic blood pressure of 130-169 mmhg and / or a sitting clinic diastolic blood pressure of 80-109 mmhg.
Beschreibung

Diabetes Mellitus | Chronic Kidney Disease | Sitting systolic blood pressure | Sitting diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C1561643
UMLS CUI [3]
C1319893
UMLS CUI [4]
C1319894
patient has a heart rate >70 b/min at baseline (before starting bisoprolol treatment)
Beschreibung

Heart rate

Datentyp

boolean

Alias
UMLS CUI [1]
C0018810
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
secondary hypertension
Beschreibung

Secondary hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0155616
pregnant or lactating women and women with childbearing potential not using adequate method of contraception or agreeing to maintain sexual abstinence throughout the study;
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Sexual Abstinence Unwilling

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0036899
UMLS CUI [4,3]
C0558080
unstable angina, history of myocardial infarction, stroke or coronary heart disease (coronary by-pass or angioplasty) in the previous 3 months;
Beschreibung

Angina, Unstable | Myocardial Infarction | Cerebrovascular accident | Coronary heart disease | Coronary Artery Bypass Surgery | Coronary angioplasty

Datentyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0010068
UMLS CUI [5]
C0010055
UMLS CUI [6]
C0190211
heart failure (new york heart association [nyha] iii-iv);
Beschreibung

Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
haemodynamically relevant aortic or mitral valve disease;
Beschreibung

Aortic valve disorder Relevance Hemodynamic | Disease of mitral valve Relevance Hemodynamic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1260873
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0019010
UMLS CUI [2,1]
C0026265
UMLS CUI [2,2]
C2347946
UMLS CUI [2,3]
C0019010
obstructive hypertensive cardiomyopathy;
Beschreibung

Hypertensive cardiomyopathy Obstructive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1144799
UMLS CUI [1,2]
C0549186
symptomatic bradycardia, second or third degree atrio-ventricular (av) block, sick sinus syndrome, sinoatrial block, or heart rate <70 b/min at baseline (before starting bisoprolol treatment);
Beschreibung

BRADYCARDIA SYMPTOMATIC | Second degree atrioventricular block | Complete atrioventricular block | Sick Sinus Syndrome | Sinoatrial Block | Heart rate

Datentyp

boolean

Alias
UMLS CUI [1]
C0741627
UMLS CUI [2]
C0264906
UMLS CUI [3]
C0151517
UMLS CUI [4]
C0037052
UMLS CUI [5]
C0037188
UMLS CUI [6]
C0018810
primary hyperaldosteronism;
Beschreibung

Conn Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C1384514
renal artery stenosis;
Beschreibung

Renal Artery Stenosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0035067
impairment of hepatic or renal function as defined by liver function values of alt
Beschreibung

Liver Dysfunction | Renal Insufficiency | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0151905
≥1.5-fold the upper normal limit or serum creatinine >150 µmol/l or upon investigator decision;
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
history of intolerance to beta-blockers the drug classes used in the study.
Beschreibung

Intolerance to Adrenergic beta-1 Receptor Antagonists

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0304516
patients with a known contraindication to beta-blockers, e.g. bradycardia, asthma, severe peripheral vascular disease.
Beschreibung

Medical contraindication Adrenergic beta-1 Receptor Antagonists | Bradycardia | Asthma | Peripheral Vascular Diseases Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0304516
UMLS CUI [2]
C0428977
UMLS CUI [3]
C0004096
UMLS CUI [4,1]
C0085096
UMLS CUI [4,2]
C0205082
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Ähnliche Modelle

Eligibility Hypertension NCT02398929

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension
Item
patients with essential hypertension
boolean
C0085580 (UMLS CUI [1])
Patients Hypertensive Uncomplicated | Antihypertensive therapy Absent | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
for uncomplicated hypertensive patients on no antihypertensive treatment, sitting clinic systolic blood pressure of 140-169 mmhg and / or a sitting clinic diastolic blood pressure of 90-109 mmhg.
boolean
C0030705 (UMLS CUI [1,1])
C0857121 (UMLS CUI [1,2])
C0443334 (UMLS CUI [1,3])
C0585941 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3])
C1319894 (UMLS CUI [4])
Diabetes Mellitus | Chronic Kidney Disease | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
for patients with diabetes mellitus or with chronic kidney disease, sitting clinic systolic blood pressure of 130-169 mmhg and / or a sitting clinic diastolic blood pressure of 80-109 mmhg.
boolean
C0011849 (UMLS CUI [1])
C1561643 (UMLS CUI [2])
C1319893 (UMLS CUI [3])
C1319894 (UMLS CUI [4])
Heart rate
Item
patient has a heart rate >70 b/min at baseline (before starting bisoprolol treatment)
boolean
C0018810 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension
Item
secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Sexual Abstinence Unwilling
Item
pregnant or lactating women and women with childbearing potential not using adequate method of contraception or agreeing to maintain sexual abstinence throughout the study;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Angina, Unstable | Myocardial Infarction | Cerebrovascular accident | Coronary heart disease | Coronary Artery Bypass Surgery | Coronary angioplasty
Item
unstable angina, history of myocardial infarction, stroke or coronary heart disease (coronary by-pass or angioplasty) in the previous 3 months;
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0010068 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C0190211 (UMLS CUI [6])
Heart failure New York Heart Association Classification
Item
heart failure (new york heart association [nyha] iii-iv);
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Aortic valve disorder Relevance Hemodynamic | Disease of mitral valve Relevance Hemodynamic
Item
haemodynamically relevant aortic or mitral valve disease;
boolean
C1260873 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0019010 (UMLS CUI [1,3])
C0026265 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0019010 (UMLS CUI [2,3])
Hypertensive cardiomyopathy Obstructive
Item
obstructive hypertensive cardiomyopathy;
boolean
C1144799 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
BRADYCARDIA SYMPTOMATIC | Second degree atrioventricular block | Complete atrioventricular block | Sick Sinus Syndrome | Sinoatrial Block | Heart rate
Item
symptomatic bradycardia, second or third degree atrio-ventricular (av) block, sick sinus syndrome, sinoatrial block, or heart rate <70 b/min at baseline (before starting bisoprolol treatment);
boolean
C0741627 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
C0037052 (UMLS CUI [4])
C0037188 (UMLS CUI [5])
C0018810 (UMLS CUI [6])
Conn Syndrome
Item
primary hyperaldosteronism;
boolean
C1384514 (UMLS CUI [1])
Renal Artery Stenosis
Item
renal artery stenosis;
boolean
C0035067 (UMLS CUI [1])
Liver Dysfunction | Renal Insufficiency | Alanine aminotransferase increased
Item
impairment of hepatic or renal function as defined by liver function values of alt
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Creatinine measurement, serum
Item
≥1.5-fold the upper normal limit or serum creatinine >150 µmol/l or upon investigator decision;
boolean
C0201976 (UMLS CUI [1])
Intolerance to Adrenergic beta-1 Receptor Antagonists
Item
history of intolerance to beta-blockers the drug classes used in the study.
boolean
C1744706 (UMLS CUI [1,1])
C0304516 (UMLS CUI [1,2])
Medical contraindication Adrenergic beta-1 Receptor Antagonists | Bradycardia | Asthma | Peripheral Vascular Diseases Severe
Item
patients with a known contraindication to beta-blockers, e.g. bradycardia, asthma, severe peripheral vascular disease.
boolean
C1301624 (UMLS CUI [1,1])
C0304516 (UMLS CUI [1,2])
C0428977 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C0085096 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
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