ID

39463

Beskrivning

Sildenafil Versus Placebo in Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01616381

Länk

https://clinicaltrials.gov/show/NCT01616381

Nyckelord

Versioner (1)
  1. 2020-01-13 2020-01-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 januari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01616381

Engelsk

Eligibility Heart Failure NCT01616381

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
2. 18 - 80 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. outpatients with chronic hf. nyha class ii-iii on optimal treatment in sinus rhythm or atrial fibrillation
Beskrivning

Outpatients | Chronic heart failure New York Heart Association Classification | Therapy Optimal | Sinus rhythm | Atrial Fibrillation

Datatyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2,1]
C0264716
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2698651
UMLS CUI [4]
C0232201
UMLS CUI [5]
C0004238
4. lvef < 40% measured during the past 12 months
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
5. spap > 40mmhg using echocardiography
Beskrivning

Pulmonary artery systolic pressure Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428643
UMLS CUI [1,2]
C0013516
6. 6mwtd < 400 meters
Beskrivning

6-Minute Walk Test Distance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0012751
7. nt-pro bnp > 400 pg/ml or bnp >100 pg/ml, measured during the past 12 months
Beskrivning

N-Terminal ProB-type Natriuretic Peptide Measurement | Brain natriuretic peptide measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C3272900
UMLS CUI [2]
C1095989
8. receiving optimal therapy, including diuretic, ace-inhibitor, arb, beta-blocker and aldosterone antagonist. doses of all medication should be unchanged during the last 30 days before inclusion.
Beskrivning

Therapy Optimal | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Aldosterone Antagonists | Pharmaceutical Preparations Dose unchanged

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [2]
C0012798
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
UMLS CUI [5]
C0304516
UMLS CUI [6]
C0002007
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C0178602
UMLS CUI [7,3]
C0442739
9. icds and crts (crt-p, crt-d) are permitted. implantation should have been performed at > 3 months before inclusion to the trial.
Beskrivning

Implantable defibrillator allowed | Cardiac Resynchronization Therapy allowed | CRT-P allowed | Implantation of CRT-D allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162589
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C1167956
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C4270800
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C1135480
UMLS CUI [4,2]
C0683607
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. acute coronary syndrome, including myocardial infarction, or coronary angiography, with or without intervention, within the last 3 months
Beskrivning

Acute Coronary Syndrome | Myocardial Infarction | Coronary angiography with Intervention | Coronary angiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0085532
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0184661
UMLS CUI [4]
C0085532
2. stroke within the last 3 months
Beskrivning

Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
3. planned coronary angiography or planned device-implantation
Beskrivning

Coronary angiography Planned | Insertion of therapeutic device Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085532
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0184961
UMLS CUI [2,2]
C1301732
4. moderate to severe obstructive valve disease
Beskrivning

Valvular disease Obstructive Moderate | Valvular disease Obstructive Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0549186
UMLS CUI [1,3]
C0205081
UMLS CUI [2,1]
C3258293
UMLS CUI [2,2]
C0549186
UMLS CUI [2,3]
C0205082
5. documented episodes of sustained ventricular tachycardia
Beskrivning

Episodes Sustained ventricular tachycardia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0750197
6. oral nitrate therapy or frequent use of sublingual nitrate
Beskrivning

Nitrates Oral | Nitrates Sublingual Frequent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0028125
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0028125
UMLS CUI [2,2]
C0001565
UMLS CUI [2,3]
C0332183
7. concomitant disease which interfere with assessment of dyspnoea , severe copd, asthma, restrictive lung disease, severe obesity
Beskrivning

Comorbidity Interferes with Assessment | Dyspnea | Severe chronic obstructive pulmonary disease | Asthma | Restrictive lung disease | Obesity, Morbid

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1516048
UMLS CUI [2]
C0013404
UMLS CUI [3]
C0730607
UMLS CUI [4]
C0004096
UMLS CUI [5]
C0085581
UMLS CUI [6]
C0028756
8. anemia (hemoglobin < 10g/dl)
Beskrivning

Anemia | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
9. uncontrolled hypertension ( sbp >160 mmhg and / or dbp > 90 mmhg)
Beskrivning

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
10. symptomatic or orthostatic hypotension or systolic blood pressure < 90 mmhg
Beskrivning

Hypotension symptomatic | Hypotension, Orthostatic | Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0863113
UMLS CUI [2]
C0020651
UMLS CUI [3]
C0871470
11. clinically important renal dysfunction (gfr < 40m ml/min)
Beskrivning

Renal dysfunction | Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0017654
12. women with child-bearing potential
Beskrivning

Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
13. use of
Beskrivning

Use of

Datatyp

boolean

Alias
UMLS CUI [1]
C1524063
i) alpha-1 antagonist: doxazosin
Beskrivning

Adrenergic alpha-1 Receptor Antagonists | Doxazosin

Datatyp

boolean

Alias
UMLS CUI [1]
C0304512
UMLS CUI [2]
C0114873
ii) cyp3a4 inhibitors: erytromycin, ritonavir, sakinovir, itraconazole, ketoconazole
Beskrivning

CYP3A4 Inhibitors | Erythromycin | Ritonavir | Other Coding | Itraconazole | Ketoconazole

Datatyp

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C0014806
UMLS CUI [3]
C0292818
UMLS CUI [4]
C3846158
UMLS CUI [5]
C0064113
UMLS CUI [6]
C0022625
iii) cyp3a4-inducers: rifampicin
Beskrivning

CYP3A4 Inducers | Rifampin

Datatyp

boolean

Alias
UMLS CUI [1]
C3850041
UMLS CUI [2]
C0035608
iv) any calcium channel blockers
Beskrivning

Calcium Channel Blockers

Datatyp

boolean

Alias
UMLS CUI [1]
C0006684
14. retinitis pigmentosa, previous diagnosis of naion (non-arteritic ischemic optic-neuropathy), unexplained visual disturbance.
Beskrivning

Retinitis Pigmentosa | Nonarteritic anterior ischemic optic neuropathy (NAION) | Visual disturbance Unexplained

Datatyp

boolean

Alias
UMLS CUI [1]
C0035334
UMLS CUI [2]
C1852242
UMLS CUI [3,1]
C0547030
UMLS CUI [3,2]
C4288071
15. sickle cell anemia, multiple myeloma, leukemia or penile anatomic deformities (angulation, cavernosal fibrosis, peyronie`s disease) that increases the risk of priapism.
Beskrivning

Anemia, Sickle Cell | Multiple Myeloma | Leukemia | Penis Deformity | Penis bent | Fibrosis of corpus cavernosum | Peyronie Disease | At risk Priapism

Datatyp

boolean

Alias
UMLS CUI [1]
C0002895
UMLS CUI [2]
C0026764
UMLS CUI [3]
C0023418
UMLS CUI [4,1]
C0030851
UMLS CUI [4,2]
C0000768
UMLS CUI [5]
C0403769
UMLS CUI [6]
C0269014
UMLS CUI [7]
C0030848
UMLS CUI [8,1]
C1444641
UMLS CUI [8,2]
C0033117
16. hepatic failure.
Beskrivning

Liver Failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0085605
17. drug and alcohol abuse which precludes compliance with the protocol.
Beskrivning

Substance Use Disorders | Protocol Compliance Excluded

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0332196
18. inability to understand or sign the written informed consent form of the study,
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Heart Failure NCT01616381

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
1. men and women
boolean
C0079399 (UMLS CUI [1])
Age
Item
2. 18 - 80 years of age.
boolean
C0001779 (UMLS CUI [1])
Outpatients | Chronic heart failure New York Heart Association Classification | Therapy Optimal | Sinus rhythm | Atrial Fibrillation
Item
3. outpatients with chronic hf. nyha class ii-iii on optimal treatment in sinus rhythm or atrial fibrillation
boolean
C0029921 (UMLS CUI [1])
C0264716 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C2698651 (UMLS CUI [3,2])
C0232201 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
Left ventricular ejection fraction
Item
4. lvef < 40% measured during the past 12 months
boolean
C0428772 (UMLS CUI [1])
Pulmonary artery systolic pressure Echocardiography
Item
5. spap > 40mmhg using echocardiography
boolean
C0428643 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
6-Minute Walk Test Distance
Item
6. 6mwtd < 400 meters
boolean
C0430515 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
N-Terminal ProB-type Natriuretic Peptide Measurement | Brain natriuretic peptide measurement
Item
7. nt-pro bnp > 400 pg/ml or bnp >100 pg/ml, measured during the past 12 months
boolean
C3272900 (UMLS CUI [1])
C1095989 (UMLS CUI [2])
Therapy Optimal | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Aldosterone Antagonists | Pharmaceutical Preparations Dose unchanged
Item
8. receiving optimal therapy, including diuretic, ace-inhibitor, arb, beta-blocker and aldosterone antagonist. doses of all medication should be unchanged during the last 30 days before inclusion.
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C0304516 (UMLS CUI [5])
C0002007 (UMLS CUI [6])
C0013227 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0442739 (UMLS CUI [7,3])
Implantable defibrillator allowed | Cardiac Resynchronization Therapy allowed | CRT-P allowed | Implantation of CRT-D allowed
Item
9. icds and crts (crt-p, crt-d) are permitted. implantation should have been performed at > 3 months before inclusion to the trial.
boolean
C0162589 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C1167956 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C4270800 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C1135480 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Acute Coronary Syndrome | Myocardial Infarction | Coronary angiography with Intervention | Coronary angiography
Item
1. acute coronary syndrome, including myocardial infarction, or coronary angiography, with or without intervention, within the last 3 months
boolean
C0948089 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0085532 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0184661 (UMLS CUI [3,3])
C0085532 (UMLS CUI [4])
Cerebrovascular accident
Item
2. stroke within the last 3 months
boolean
C0038454 (UMLS CUI [1])
Coronary angiography Planned | Insertion of therapeutic device Planned
Item
3. planned coronary angiography or planned device-implantation
boolean
C0085532 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0184961 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Valvular disease Obstructive Moderate | Valvular disease Obstructive Severe
Item
4. moderate to severe obstructive valve disease
boolean
C3258293 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C3258293 (UMLS CUI [2,1])
C0549186 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Episodes Sustained ventricular tachycardia
Item
5. documented episodes of sustained ventricular tachycardia
boolean
C0332189 (UMLS CUI [1,1])
C0750197 (UMLS CUI [1,2])
Nitrates Oral | Nitrates Sublingual Frequent
Item
6. oral nitrate therapy or frequent use of sublingual nitrate
boolean
C0028125 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0028125 (UMLS CUI [2,1])
C0001565 (UMLS CUI [2,2])
C0332183 (UMLS CUI [2,3])
Comorbidity Interferes with Assessment | Dyspnea | Severe chronic obstructive pulmonary disease | Asthma | Restrictive lung disease | Obesity, Morbid
Item
7. concomitant disease which interfere with assessment of dyspnoea , severe copd, asthma, restrictive lung disease, severe obesity
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0013404 (UMLS CUI [2])
C0730607 (UMLS CUI [3])
C0004096 (UMLS CUI [4])
C0085581 (UMLS CUI [5])
C0028756 (UMLS CUI [6])
Anemia | Hemoglobin measurement
Item
8. anemia (hemoglobin < 10g/dl)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
9. uncontrolled hypertension ( sbp >160 mmhg and / or dbp > 90 mmhg)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hypotension symptomatic | Hypotension, Orthostatic | Systolic Pressure
Item
10. symptomatic or orthostatic hypotension or systolic blood pressure < 90 mmhg
boolean
C0863113 (UMLS CUI [1])
C0020651 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
Renal dysfunction | Glomerular Filtration Rate
Item
11. clinically important renal dysfunction (gfr < 40m ml/min)
boolean
C3279454 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
Childbearing Potential
Item
12. women with child-bearing potential
boolean
C3831118 (UMLS CUI [1])
Use of
Item
13. use of
boolean
C1524063 (UMLS CUI [1])
Adrenergic alpha-1 Receptor Antagonists | Doxazosin
Item
i) alpha-1 antagonist: doxazosin
boolean
C0304512 (UMLS CUI [1])
C0114873 (UMLS CUI [2])
CYP3A4 Inhibitors | Erythromycin | Ritonavir | Other Coding | Itraconazole | Ketoconazole
Item
ii) cyp3a4 inhibitors: erytromycin, ritonavir, sakinovir, itraconazole, ketoconazole
boolean
C3850053 (UMLS CUI [1])
C0014806 (UMLS CUI [2])
C0292818 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
C0064113 (UMLS CUI [5])
C0022625 (UMLS CUI [6])
CYP3A4 Inducers | Rifampin
Item
iii) cyp3a4-inducers: rifampicin
boolean
C3850041 (UMLS CUI [1])
C0035608 (UMLS CUI [2])
Calcium Channel Blockers
Item
iv) any calcium channel blockers
boolean
C0006684 (UMLS CUI [1])
Retinitis Pigmentosa | Nonarteritic anterior ischemic optic neuropathy (NAION) | Visual disturbance Unexplained
Item
14. retinitis pigmentosa, previous diagnosis of naion (non-arteritic ischemic optic-neuropathy), unexplained visual disturbance.
boolean
C0035334 (UMLS CUI [1])
C1852242 (UMLS CUI [2])
C0547030 (UMLS CUI [3,1])
C4288071 (UMLS CUI [3,2])
Anemia, Sickle Cell | Multiple Myeloma | Leukemia | Penis Deformity | Penis bent | Fibrosis of corpus cavernosum | Peyronie Disease | At risk Priapism
Item
15. sickle cell anemia, multiple myeloma, leukemia or penile anatomic deformities (angulation, cavernosal fibrosis, peyronie`s disease) that increases the risk of priapism.
boolean
C0002895 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
C0023418 (UMLS CUI [3])
C0030851 (UMLS CUI [4,1])
C0000768 (UMLS CUI [4,2])
C0403769 (UMLS CUI [5])
C0269014 (UMLS CUI [6])
C0030848 (UMLS CUI [7])
C1444641 (UMLS CUI [8,1])
C0033117 (UMLS CUI [8,2])
Liver Failure
Item
16. hepatic failure.
boolean
C0085605 (UMLS CUI [1])
Substance Use Disorders | Protocol Compliance Excluded
Item
17. drug and alcohol abuse which precludes compliance with the protocol.
boolean
C0038586 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Informed Consent Unable
Item
18. inability to understand or sign the written informed consent form of the study,
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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