ID

29463

Description

Evaluation of Sildenafil for the Treatment of Moderate Congestive Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00793338

Link

https://clinicaltrials.gov/show/NCT00793338

Keywords

Versions (1)
  1. 3/28/18 3/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00793338

English

Eligibility Heart Failure NCT00793338

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age greater than 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of chronic heart failure with an ejection fraction less than or equal to 45% per either an echocardiogram, nuclear cardiolyte stress test, or cardiac catheterization performed within the past 6 months.
Description

Chronic heart failure | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Nuclear Stress Test | Cardiac ejection fraction Cardiac Catheterization

Data type

boolean

Alias
UMLS CUI [1]
C0264716
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
UMLS CUI [3,1]
C0232174
UMLS CUI [3,2]
C2825165
UMLS CUI [4,1]
C0232174
UMLS CUI [4,2]
C0018795
new york heart association functional class iii
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
must be on optimal heart failure therapy according to aha/acc heart failure guidelines, including treatment with acei and beta-blocker therapy, or have documented rationale for variation, including intolerance, contraindication, patient preference, or personal physician's judgment
Description

Therapeutic procedure Optimal Heart failure | Angiotensin-Converting Enzyme Inhibitors | Adrenergic beta-1 Receptor Antagonists | Rationale Variation | Intolerance | Medical contraindication | Patient Preference

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0018801
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0304516
UMLS CUI [4,1]
C2699007
UMLS CUI [4,2]
C0205419
UMLS CUI [5]
C1744706
UMLS CUI [6]
C1301624
UMLS CUI [7]
C0376409
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
comorbid disease or behavioral or other limitations that: 1) interfere with performing exercise test, or 2) prevent completion of 12 week study
Description

Comorbidity Interferes with Exercise testing | Behavior problem Interferes with Exercise testing | Comorbidity Preventing Completion of clinical trial | Behavior problem Preventing Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0015260
UMLS CUI [2,1]
C0233514
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0015260
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C2732579
UMLS CUI [4,1]
C0233514
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C2732579
currently pregnant or intent to become pregnant in the next 12 weeks or currently breastfeeding.
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
major cardiovascular event or cardiovascular procedure within the prior 6 weeks
Description

Cardiovascular event Major | Cardiovascular procedures Major

Data type

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0189573
UMLS CUI [2,2]
C0205164
history of chronic obstructive pulmonary disease or reactive airway disease
Description

Chronic Obstructive Airway Disease | Reactive airway disease

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C3714497
known hypersensitivity to sildenafil
Description

Hypersensitivity Sildenafil

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0529793
current use of medications known to be a potent inhibitor of cyp3a4 (e.g., ritonavir, ketoconazole, itraconazole)
Description

Cytochrome P450 3A4 Inhibitor | Ritonavir | Ketoconazole | Itraconazole

Data type

boolean

Alias
UMLS CUI [1]
C3830624
UMLS CUI [2]
C0292818
UMLS CUI [3]
C0022625
UMLS CUI [4]
C0064113
current or recent (within 6 months) use of organic nitrate medications (e.g. isosorbide dinitrate, sublingual nitroglycerin)
Description

Organic nitrates | Isosorbide Dinitrate | Nitroglycerin Sublingual Product

Data type

boolean

Alias
UMLS CUI [1]
C3654024
UMLS CUI [2]
C0022252
UMLS CUI [3]
C3466369
known diagnosis of pulmonary veno-occlusive disease or non-arteritic anterior ischemic optic neuropathy
Description

Pulmonary Veno-Occlusive Disease | Nonarteritic anterior ischemic optic neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0034091
UMLS CUI [2]
C1852242
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Similar models

Eligibility Heart Failure NCT00793338

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age greater than 18 years
boolean
C0001779 (UMLS CUI [1])
Chronic heart failure | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Nuclear Stress Test | Cardiac ejection fraction Cardiac Catheterization
Item
diagnosis of chronic heart failure with an ejection fraction less than or equal to 45% per either an echocardiogram, nuclear cardiolyte stress test, or cardiac catheterization performed within the past 6 months.
boolean
C0264716 (UMLS CUI [1])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0232174 (UMLS CUI [3,1])
C2825165 (UMLS CUI [3,2])
C0232174 (UMLS CUI [4,1])
C0018795 (UMLS CUI [4,2])
New York Heart Association Classification
Item
new york heart association functional class iii
boolean
C1275491 (UMLS CUI [1])
Therapeutic procedure Optimal Heart failure | Angiotensin-Converting Enzyme Inhibitors | Adrenergic beta-1 Receptor Antagonists | Rationale Variation | Intolerance | Medical contraindication | Patient Preference
Item
must be on optimal heart failure therapy according to aha/acc heart failure guidelines, including treatment with acei and beta-blocker therapy, or have documented rationale for variation, including intolerance, contraindication, patient preference, or personal physician's judgment
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2])
C0304516 (UMLS CUI [3])
C2699007 (UMLS CUI [4,1])
C0205419 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5])
C1301624 (UMLS CUI [6])
C0376409 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Comorbidity Interferes with Exercise testing | Behavior problem Interferes with Exercise testing | Comorbidity Preventing Completion of clinical trial | Behavior problem Preventing Completion of clinical trial
Item
comorbid disease or behavioral or other limitations that: 1) interfere with performing exercise test, or 2) prevent completion of 12 week study
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0015260 (UMLS CUI [1,3])
C0233514 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0015260 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C0233514 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])
Pregnancy | Pregnancy, Planned
Item
currently pregnant or intent to become pregnant in the next 12 weeks or currently breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Cardiovascular event Major | Cardiovascular procedures Major
Item
major cardiovascular event or cardiovascular procedure within the prior 6 weeks
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0189573 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
Chronic Obstructive Airway Disease | Reactive airway disease
Item
history of chronic obstructive pulmonary disease or reactive airway disease
boolean
C0024117 (UMLS CUI [1])
C3714497 (UMLS CUI [2])
Hypersensitivity Sildenafil
Item
known hypersensitivity to sildenafil
boolean
C0020517 (UMLS CUI [1,1])
C0529793 (UMLS CUI [1,2])
Cytochrome P450 3A4 Inhibitor | Ritonavir | Ketoconazole | Itraconazole
Item
current use of medications known to be a potent inhibitor of cyp3a4 (e.g., ritonavir, ketoconazole, itraconazole)
boolean
C3830624 (UMLS CUI [1])
C0292818 (UMLS CUI [2])
C0022625 (UMLS CUI [3])
C0064113 (UMLS CUI [4])
Organic nitrates | Isosorbide Dinitrate | Nitroglycerin Sublingual Product
Item
current or recent (within 6 months) use of organic nitrate medications (e.g. isosorbide dinitrate, sublingual nitroglycerin)
boolean
C3654024 (UMLS CUI [1])
C0022252 (UMLS CUI [2])
C3466369 (UMLS CUI [3])
Pulmonary Veno-Occlusive Disease | Nonarteritic anterior ischemic optic neuropathy
Item
known diagnosis of pulmonary veno-occlusive disease or non-arteritic anterior ischemic optic neuropathy
boolean
C0034091 (UMLS CUI [1])
C1852242 (UMLS CUI [2])
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