ID

39484

Descrição

Renal Denervation in Patients With Heart Failure and Severe Left Ventricular Dysfunction.; ODM derived from: https://clinicaltrials.gov/show/NCT01870310

Link

https://clinicaltrials.gov/show/NCT01870310

Palavras-chave

Versões (1)
  1. 16/01/2020 16/01/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

16 de janeiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01870310

Inglês

Eligibility Heart Failure NCT01870310

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients over 18 years of age with chronic heart failure, ischemic and non-ischemic etiology.
Descrição

Age | Chronic heart failure | Etiology Ischemic | Etiology Other

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0264716
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0475224
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0205394
nyha (new york heart association) class ii-iv.
Descrição

New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1275491
lvef (left ventricular ejection fraction) ≤ 35%.
Descrição

Left ventricular ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428772
patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure, who were stable for at least four weeks without acute decompensated heart failure.
Descrição

Pharmacotherapy Maximum Tolerated Dose Heart failure | Standard Pharmacotherapy Stable | Decompensated cardiac failure Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0752079
UMLS CUI [1,3]
C0018801
UMLS CUI [2,1]
C1442989
UMLS CUI [2,2]
C0013216
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0581377
UMLS CUI [3,2]
C0332197
prior to enrollment, patients must give informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with history of acute coronary syndrome or stroke within the last 6 months.
Descrição

Acute Coronary Syndrome | Cerebrovascular accident

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
significant valvular defects and/or planned cardiac surgery.
Descrição

Valvular defects | Cardiac Surgery Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2748945
UMLS CUI [2,1]
C0018821
UMLS CUI [2,2]
C1301732
systolic blood pressure <110 mmhg.
Descrição

Systolic Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0871470
advanced renal insufficiency (estimated gfr (glomerular filtration rate) according to mdrd <30 ml/min/1.73 square meters).
Descrição

Renal Insufficiency Advanced | GFR estimation by MDRD

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C2170215
unsuitable anatomy of renal arteries (presence of significant renal stenosis, renal artery narrower than 4 mm).
Descrição

Renal artery Anatomy Inappropriate | Renal Artery Stenosis | Renal artery Thickness

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C1548788
UMLS CUI [2]
C0035067
UMLS CUI [3,1]
C0035065
UMLS CUI [3,2]
C1280412
patients who underwent renal angioplasty or stent placement into the renal artery in the past.
Descrição

Angioplasty renal artery | Renal artery stent placement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1282893
UMLS CUI [2]
C1609503
severe coagulation disorders.
Descrição

Blood Coagulation Disorders Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0205082
pregnancy or lactation.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
refusal of the patient.
Descrição

Patient Refusal to Participate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1136454
other diseases limiting prognosis of the patient to less than 2 years.
Descrição

Disease Limiting Prognosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0033325
other reasons which in the opinion of the attending physician would preclude the individual from participating in the study.
Descrição

Study Subject Participation Status Unsuitable for other reasons

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3844399
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Similar models

Eligibility Heart Failure NCT01870310

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Chronic heart failure | Etiology Ischemic | Etiology Other
Item
patients over 18 years of age with chronic heart failure, ischemic and non-ischemic etiology.
boolean
C0001779 (UMLS CUI [1])
C0264716 (UMLS CUI [2])
C0015127 (UMLS CUI [3,1])
C0475224 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
New York Heart Association Classification
Item
nyha (new york heart association) class ii-iv.
boolean
C1275491 (UMLS CUI [1])
Left ventricular ejection fraction
Item
lvef (left ventricular ejection fraction) ≤ 35%.
boolean
C0428772 (UMLS CUI [1])
Pharmacotherapy Maximum Tolerated Dose Heart failure | Standard Pharmacotherapy Stable | Decompensated cardiac failure Absent
Item
patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure, who were stable for at least four weeks without acute decompensated heart failure.
boolean
C0013216 (UMLS CUI [1,1])
C0752079 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C1442989 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0581377 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent
Item
prior to enrollment, patients must give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Coronary Syndrome | Cerebrovascular accident
Item
patients with history of acute coronary syndrome or stroke within the last 6 months.
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Valvular defects | Cardiac Surgery Planned
Item
significant valvular defects and/or planned cardiac surgery.
boolean
C2748945 (UMLS CUI [1])
C0018821 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Systolic Pressure
Item
systolic blood pressure <110 mmhg.
boolean
C0871470 (UMLS CUI [1])
Renal Insufficiency Advanced | GFR estimation by MDRD
Item
advanced renal insufficiency (estimated gfr (glomerular filtration rate) according to mdrd <30 ml/min/1.73 square meters).
boolean
C1565489 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Renal artery Anatomy Inappropriate | Renal Artery Stenosis | Renal artery Thickness
Item
unsuitable anatomy of renal arteries (presence of significant renal stenosis, renal artery narrower than 4 mm).
boolean
C0035065 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0035067 (UMLS CUI [2])
C0035065 (UMLS CUI [3,1])
C1280412 (UMLS CUI [3,2])
Angioplasty renal artery | Renal artery stent placement
Item
patients who underwent renal angioplasty or stent placement into the renal artery in the past.
boolean
C1282893 (UMLS CUI [1])
C1609503 (UMLS CUI [2])
Blood Coagulation Disorders Severe
Item
severe coagulation disorders.
boolean
C0005779 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Patient Refusal to Participate
Item
refusal of the patient.
boolean
C0030705 (UMLS CUI [1,1])
C1136454 (UMLS CUI [1,2])
Disease Limiting Prognosis
Item
other diseases limiting prognosis of the patient to less than 2 years.
boolean
C0012634 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0033325 (UMLS CUI [1,3])
Study Subject Participation Status Unsuitable for other reasons
Item
other reasons which in the opinion of the attending physician would preclude the individual from participating in the study.
boolean
C2348568 (UMLS CUI [1,1])
C3844399 (UMLS CUI [1,2])
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