ID

39484

Beschrijving

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

Trefwoorden

Versies (1)
  1. 16-01-20 16-01-20 -
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See clinicaltrials.gov

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16 januari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT01870310

Engels

Eligibility Heart Failure NCT01870310

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age | Chronic heart failure | Etiology Ischemic | Etiology Other

Datatype

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.
Beschrijving

New York Heart Association Classification

Datatype

boolean

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

Left ventricular ejection fraction

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Acute Coronary Syndrome | Cerebrovascular accident

Datatype

boolean

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

Valvular defects | Cardiac Surgery Planned

Datatype

boolean

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

Systolic Pressure

Datatype

boolean

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

Renal Insufficiency Advanced | GFR estimation by MDRD

Datatype

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).
Beschrijving

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

Datatype

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.
Beschrijving

Angioplasty renal artery | Renal artery stent placement

Datatype

boolean

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

Blood Coagulation Disorders Severe

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Patient Refusal to Participate

Datatype

boolean

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

Disease Limiting Prognosis

Datatype

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.
Beschrijving

Study Subject Participation Status Unsuitable for other reasons

Datatype

boolean

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

Eligibility Heart Failure NCT01870310

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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