ID

17421

Beschreibung

Novel Treatment for Diastolic Heart Failure in Women; ODM derived from: https://clinicaltrials.gov/show/NCT00206232

Link

https://clinicaltrials.gov/show/NCT00206232

Stichworte

Versionen (1)
  1. 13.09.16 13.09.16 -
Hochgeladen am

13. September 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00206232

Englisch

Eligibility Heart Failure NCT00206232

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
women who are 18 years of age or older.
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
women with clinical heart failure for > 2 months.
Beschreibung

Gender | Heart failure Clinical

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0205210
women with left ventricular ejection fraction > 50% within 2 months of screening.
Beschreibung

Gender | Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0428772
women with new york heart association class ii or iii heart failure symptoms.
Beschreibung

Gender | Symptoms heart failure | New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C2735647
UMLS CUI [3]
C1275491
brain natriuretic peptide > 62 pg/ml within 2 months of screening.
Beschreibung

Brain natriuretic peptide measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1095989
patient on angiotensin converting enzyme inhibitor or angiotensin receptor blocker therapy for at least 1 month.
Beschreibung

Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Datentyp

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0521942
blood pressure no more than 150/95.
Beschreibung

Blood Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0005823
patient able to walk more than 50 meters at the time of enrollment.
Beschreibung

Able to walk Walking distance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0429886
signed informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
current treatment with spironolactone.
Beschreibung

Spironolactone

Datentyp

boolean

Alias
UMLS CUI [1]
C0037982
severe hepatic impairment.
Beschreibung

Hepatic impairment Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205082
creatinine > 2.5 mg/dl
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
potassium > 5.0 meq/l
Beschreibung

Potassium measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202194
intolerance to spironolactone in the past.
Beschreibung

intolerance to Spironolactone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0037982
significant valvular heart disease, pericardial disease, or severe chronic lung disease with cor pulmonale.
Beschreibung

Heart valve disease Significant | Disorder of pericardium | Severe chronic lung disease | Cor pulmonale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0265122
UMLS CUI [3]
C3278799
UMLS CUI [4]
C0034072
unstable angina or myocardial infarction within the past 4 weeks.
Beschreibung

Angina, Unstable | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
severe peripheral vascular disease or other physical conditions that would limit the walking distance.
Beschreibung

Peripheral Vascular Disease Severe Limiting Walking distance | Physical Condition Limiting Walking distance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0429886
UMLS CUI [2,1]
C3714565
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0429886
pregnant or lactating females.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in any other drug trial within 30 days prior to randomization.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
inability to provide informed consent.
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Ähnliche Modelle

Eligibility Heart Failure NCT00206232

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women who are 18 years of age or older.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Heart failure Clinical
Item
women with clinical heart failure for > 2 months.
boolean
C0079399 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
Gender | Left ventricular ejection fraction
Item
women with left ventricular ejection fraction > 50% within 2 months of screening.
boolean
C0079399 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Gender | Symptoms heart failure | New York Heart Association Classification
Item
women with new york heart association class ii or iii heart failure symptoms.
boolean
C0079399 (UMLS CUI [1])
C2735647 (UMLS CUI [2])
C1275491 (UMLS CUI [3])
Brain natriuretic peptide measurement
Item
brain natriuretic peptide > 62 pg/ml within 2 months of screening.
boolean
C1095989 (UMLS CUI [1])
Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
patient on angiotensin converting enzyme inhibitor or angiotensin receptor blocker therapy for at least 1 month.
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
Blood Pressure
Item
blood pressure no more than 150/95.
boolean
C0005823 (UMLS CUI [1])
Able to walk Walking distance
Item
patient able to walk more than 50 meters at the time of enrollment.
boolean
C2712089 (UMLS CUI [1,1])
C0429886 (UMLS CUI [1,2])
Informed Consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Spironolactone
Item
current treatment with spironolactone.
boolean
C0037982 (UMLS CUI [1])
Hepatic impairment Severe
Item
severe hepatic impairment.
boolean
C0948807 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
creatinine > 2.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Potassium measurement
Item
potassium > 5.0 meq/l
boolean
C0202194 (UMLS CUI [1])
intolerance to Spironolactone
Item
intolerance to spironolactone in the past.
boolean
C1744706 (UMLS CUI [1,1])
C0037982 (UMLS CUI [1,2])
Heart valve disease Significant | Disorder of pericardium | Severe chronic lung disease | Cor pulmonale
Item
significant valvular heart disease, pericardial disease, or severe chronic lung disease with cor pulmonale.
boolean
C0018824 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0265122 (UMLS CUI [2])
C3278799 (UMLS CUI [3])
C0034072 (UMLS CUI [4])
Angina, Unstable | Myocardial Infarction
Item
unstable angina or myocardial infarction within the past 4 weeks.
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Peripheral Vascular Disease Severe Limiting Walking distance | Physical Condition Limiting Walking distance
Item
severe peripheral vascular disease or other physical conditions that would limit the walking distance.
boolean
C0085096 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0429886 (UMLS CUI [1,4])
C3714565 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0429886 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
participation in any other drug trial within 30 days prior to randomization.
boolean
C2348568 (UMLS CUI [1])
Informed Consent Unable
Item
inability to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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