ID

39532

Description

Sildenafil in HFpEF and PH; ODM derived from: https://clinicaltrials.gov/show/NCT01726049

Link

https://clinicaltrials.gov/show/NCT01726049

Keywords

Versions (1)
  1. 1/24/20 1/24/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 24, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure With Preserved Ejection Fraction NCT01726049

English

Eligibility Heart Failure With Preserved Ejection Fraction NCT01726049

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
>18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
written inform consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
ph secondary to diastolic left heart failure defined as
Description

Pulmonary Hypertension Secondary to Diastolic left ventricular heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C4509225
pap mean >25 mmhg
Description

Pulmonary artery mean pressure

Data type

boolean

Alias
UMLS CUI [1]
C0428645
wedge mean >15 mmhg
Description

Mean wedge pressure

Data type

boolean

Alias
UMLS CUI [1]
C0456173
normal systolic lv function on echo/muga (lvef > 45%)
Description

Normal left ventricular systolic function Echocardiography | Normal left ventricular systolic function MUGA | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1,1]
C3266756
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C3266756
UMLS CUI [2,2]
C0521317
UMLS CUI [3]
C0428772
nyha ii-iv despite hf therapy
Description

New York Heart Association Classification | Therapy Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0018801
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe noncardiac limitation to exercise (copd etc)
Description

Limitation Severe Exercise | Exception Heart Diseases | Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0449295
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0015259
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0024117
other cause of ph besides diastolic heart failure
Description

Cause Pulmonary Hypertension | Exception Diastolic Heart Failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0020542
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1135196
coronary ischemia or recent myocardial infarction (<6 months)
Description

Coronary ischaemia | Recent myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0542060
UMLS CUI [2]
C1998297
hypotension ( <90/50 mmhg)
Description

Hypotension | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0005824
ongoing nitrate therapy
Description

Nitrates

Data type

boolean

Alias
UMLS CUI [1]
C0028125
ongoing therapy with cyp3a4 inhibitors (ketoconazole, erythromycin, cimetidine, clarithromycin, itraconazole, voriconazole and protease inhibitors) or cyp3a4 inductors(carbamacepine, phenytoin, phenobarbital, rifampicin, sint janskruid ). furthermore patients will be informed not to drink grapefruit juice while on study medication because of the known impact of grape fruit on pharmacokinetics of sildenafil.
Description

CYP3A4 Inhibitors | Ketoconazole | Erythromycin | Cimetidine | Clarithromycin | Itraconazole | voriconazole | Protease Inhibitors | CYP3A4 Inducers | Carbamazepine | Phenytoin | Phenobarbital | Rifampin | ST. JOHN'S WORT EXTRACT | GRAPEFRUIT JUICE

Data type

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C0022625
UMLS CUI [3]
C0014806
UMLS CUI [4]
C0008783
UMLS CUI [5]
C0055856
UMLS CUI [6]
C0064113
UMLS CUI [7]
C0393080
UMLS CUI [8]
C0033607
UMLS CUI [9]
C3850041
UMLS CUI [10]
C0006949
UMLS CUI [11]
C0031507
UMLS CUI [12]
C0031412
UMLS CUI [13]
C0035608
UMLS CUI [14]
C0813171
UMLS CUI [15]
C0452456
ongoing therapy with alpha -inhibitors
Description

Adrenergic alpha-Antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0001641
significant mitral or aortic valve dysfunction
Description

Mitral Valve Dysfunction | Aortic valve Dysfunction

Data type

boolean

Alias
UMLS CUI [1,1]
C0026264
UMLS CUI [1,2]
C3887504
UMLS CUI [2,1]
C0003501
UMLS CUI [2,2]
C3887504
severe liver dysfunction
Description

Liver Dysfunction Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
unable to read and comprehend dutch language
Description

Lacking Able to read Dutch Language | Comprehension Dutch Language Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C0376241
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376241
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Heart Failure With Preserved Ejection Fraction NCT01726049

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
>18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written inform consent
boolean
C0021430 (UMLS CUI [1])
Pulmonary Hypertension Secondary to Diastolic left ventricular heart failure
Item
ph secondary to diastolic left heart failure defined as
boolean
C0020542 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C4509225 (UMLS CUI [1,3])
Pulmonary artery mean pressure
Item
pap mean >25 mmhg
boolean
C0428645 (UMLS CUI [1])
Mean wedge pressure
Item
wedge mean >15 mmhg
boolean
C0456173 (UMLS CUI [1])
Normal left ventricular systolic function Echocardiography | Normal left ventricular systolic function MUGA | Left ventricular ejection fraction
Item
normal systolic lv function on echo/muga (lvef > 45%)
boolean
C3266756 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C3266756 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3])
New York Heart Association Classification | Therapy Heart failure
Item
nyha ii-iv despite hf therapy
boolean
C1275491 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Limitation Severe Exercise | Exception Heart Diseases | Chronic Obstructive Airway Disease
Item
severe noncardiac limitation to exercise (copd etc)
boolean
C0449295 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0024117 (UMLS CUI [3])
Cause Pulmonary Hypertension | Exception Diastolic Heart Failure
Item
other cause of ph besides diastolic heart failure
boolean
C0015127 (UMLS CUI [1,1])
C0020542 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1135196 (UMLS CUI [2,2])
Coronary ischaemia | Recent myocardial infarction
Item
coronary ischemia or recent myocardial infarction (<6 months)
boolean
C0542060 (UMLS CUI [1])
C1998297 (UMLS CUI [2])
Hypotension | Blood pressure determination
Item
hypotension ( <90/50 mmhg)
boolean
C0020649 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Nitrates
Item
ongoing nitrate therapy
boolean
C0028125 (UMLS CUI [1])
CYP3A4 Inhibitors | Ketoconazole | Erythromycin | Cimetidine | Clarithromycin | Itraconazole | voriconazole | Protease Inhibitors | CYP3A4 Inducers | Carbamazepine | Phenytoin | Phenobarbital | Rifampin | ST. JOHN'S WORT EXTRACT | GRAPEFRUIT JUICE
Item
ongoing therapy with cyp3a4 inhibitors (ketoconazole, erythromycin, cimetidine, clarithromycin, itraconazole, voriconazole and protease inhibitors) or cyp3a4 inductors(carbamacepine, phenytoin, phenobarbital, rifampicin, sint janskruid ). furthermore patients will be informed not to drink grapefruit juice while on study medication because of the known impact of grape fruit on pharmacokinetics of sildenafil.
boolean
C3850053 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0014806 (UMLS CUI [3])
C0008783 (UMLS CUI [4])
C0055856 (UMLS CUI [5])
C0064113 (UMLS CUI [6])
C0393080 (UMLS CUI [7])
C0033607 (UMLS CUI [8])
C3850041 (UMLS CUI [9])
C0006949 (UMLS CUI [10])
C0031507 (UMLS CUI [11])
C0031412 (UMLS CUI [12])
C0035608 (UMLS CUI [13])
C0813171 (UMLS CUI [14])
C0452456 (UMLS CUI [15])
Adrenergic alpha-Antagonists
Item
ongoing therapy with alpha -inhibitors
boolean
C0001641 (UMLS CUI [1])
Mitral Valve Dysfunction | Aortic valve Dysfunction
Item
significant mitral or aortic valve dysfunction
boolean
C0026264 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
C0003501 (UMLS CUI [2,1])
C3887504 (UMLS CUI [2,2])
Liver Dysfunction Severe
Item
severe liver dysfunction
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Lacking Able to read Dutch Language | Comprehension Dutch Language Unable
Item
unable to read and comprehend dutch language
boolean
C0332268 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0376241 (UMLS CUI [1,3])
C0233733 (UMLS CUI [2,1])
C0376241 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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