ID

39463

Descripción

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

Link

https://clinicaltrials.gov/show/NCT01616381

Palabras clave

Versiones (1)
  1. 13/1/20 13/1/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

13 de enero de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Heart Failure NCT01616381

Inglés

Eligibility Heart Failure NCT01616381

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women
Descripción

Gender

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

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

Pulmonary artery systolic pressure Echocardiography

Tipo de datos

boolean

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

6-Minute Walk Test Distance

Tipo de datos

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
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Descripción

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
Descripción

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

Tipo de datos

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
Descripción

Cerebrovascular accident

Tipo de datos

boolean

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

Coronary angiography Planned | Insertion of therapeutic device Planned

Tipo de datos

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
Descripción

Valvular disease Obstructive Moderate | Valvular disease Obstructive Severe

Tipo de datos

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
Descripción

Episodes Sustained ventricular tachycardia

Tipo de datos

boolean

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

Nitrates Oral | Nitrates Sublingual Frequent

Tipo de datos

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
Descripción

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

Tipo de datos

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)
Descripción

Anemia | Hemoglobin measurement

Tipo de datos

boolean

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

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Tipo de datos

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
Descripción

Hypotension symptomatic | Hypotension, Orthostatic | Systolic Pressure

Tipo de datos

boolean

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

Renal dysfunction | Glomerular Filtration Rate

Tipo de datos

boolean

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

Childbearing Potential

Tipo de datos

boolean

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

Use of

Tipo de datos

boolean

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

Adrenergic alpha-1 Receptor Antagonists | Doxazosin

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

CYP3A4 Inducers | Rifampin

Tipo de datos

boolean

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

Calcium Channel Blockers

Tipo de datos

boolean

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

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Liver Failure

Tipo de datos

boolean

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

Substance Use Disorders | Protocol Compliance Excluded

Tipo de datos

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,
Descripción

Informed Consent Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
Volver a la parte superior de la página

Similar models

Eligibility Heart Failure NCT01616381

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial