ID

12214

Beschrijving

Effect of Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing; ODM derived from: https://clinicaltrials.gov/show/NCT01868880

Link

https://clinicaltrials.gov/show/NCT01868880

Trefwoorden

  1. 18-10-15 18-10-15 -
Geüploaded op

18 oktober 2015

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Heart Rate Control in ICD Patients With Heart Failure NCT01868880

Eligibility Heart Rate Control in ICD Patients With Heart Failure NCT01868880

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with stable chronic heart failure implanted with mono-cameral or bicameral icd with a home monitoring remote control.
Beschrijving

chronic heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0264716
moderate to severe left ventricular dysfunction (fe ≤ 40%).
Beschrijving

left ventricular dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C0242698
any cause of heart failure was allowed apart congenital heart disease.
Beschrijving

Heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
bicameral icd programmed in ddd or aai/ddd with av interval < 300 msec.
Beschrijving

pacemaker

Datatype

boolean

Alias
UMLS CUI [1]
C0030163
rest ecg heart rate ≥70 bpm;
Beschrijving

heart rate

Datatype

boolean

Alias
UMLS CUI [1]
C0018810
sinus rhythm.
Beschrijving

sinus rhythm.

Datatype

boolean

Alias
UMLS CUI [1]
C0232201
in therapy with low-dose of beta-blocker (bisoprolol 1,25-2,5 mg) and with the maximum dose tolerated of angiotensin-converting enzyme inhibitor or blockade of angiotensin ii receptor, mineralocorticoid antagonist, antiplatelet and lipid-lowering therapy, unless contraindicated.
Beschrijving

lipid-lowering therapy; angiotensin-converting enzyme inhibitor; beta-blocker

Datatype

boolean

Alias
UMLS CUI [1]
C0585943
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0001645
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability of providing informed consent;
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
age < 18 years.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
state of pregnancy or lactation.
Beschrijving

pregnant; lactating

Datatype

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
recent (<2 months) myocardial infarction;
Beschrijving

myocardial infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
contraindications to beta-blockers and ivabradine;
Beschrijving

contraindications; beta-blockers

Datatype

boolean

Alias
UMLS CUI [1]
C0683526
UMLS CUI [2]
C0001645
rest ecg heart rate < 70 bpm;
Beschrijving

heart rate

Datatype

boolean

Alias
UMLS CUI [1]
C0018810
no sinus rhythm.
Beschrijving

sinus rhythm.

Datatype

boolean

Alias
UMLS CUI [1]
C0232201
administration of non-dihydropyridinic calcium channels antagonists, digitalis, class i antiarrhythmic drugs, strong inhibitors of cytochrome p450 3a4 at the time of enrollment.
Beschrijving

antiarrhythmic drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0003195

Similar models

Eligibility Heart Rate Control in ICD Patients With Heart Failure NCT01868880

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
chronic heart failure
Item
patients with stable chronic heart failure implanted with mono-cameral or bicameral icd with a home monitoring remote control.
boolean
C0264716 (UMLS CUI [1])
left ventricular dysfunction
Item
moderate to severe left ventricular dysfunction (fe ≤ 40%).
boolean
C0242698 (UMLS CUI [1])
Heart failure
Item
any cause of heart failure was allowed apart congenital heart disease.
boolean
C0018801 (UMLS CUI [1])
pacemaker
Item
bicameral icd programmed in ddd or aai/ddd with av interval < 300 msec.
boolean
C0030163 (UMLS CUI [1])
heart rate
Item
rest ecg heart rate ≥70 bpm;
boolean
C0018810 (UMLS CUI [1])
sinus rhythm.
Item
sinus rhythm.
boolean
C0232201 (UMLS CUI [1])
lipid-lowering therapy; angiotensin-converting enzyme inhibitor; beta-blocker
Item
in therapy with low-dose of beta-blocker (bisoprolol 1,25-2,5 mg) and with the maximum dose tolerated of angiotensin-converting enzyme inhibitor or blockade of angiotensin ii receptor, mineralocorticoid antagonist, antiplatelet and lipid-lowering therapy, unless contraindicated.
boolean
C0585943 (UMLS CUI [1])
C0003015 (UMLS CUI [2])
C0001645 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
informed consent
Item
inability of providing informed consent;
boolean
C0021430 (UMLS CUI [1])
age
Item
age < 18 years.
boolean
C0001779 (UMLS CUI [1])
pregnant; lactating
Item
state of pregnancy or lactation.
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
myocardial infarction
Item
recent (<2 months) myocardial infarction;
boolean
C0027051 (UMLS CUI [1])
contraindications; beta-blockers
Item
contraindications to beta-blockers and ivabradine;
boolean
C0683526 (UMLS CUI [1])
C0001645 (UMLS CUI [2])
heart rate
Item
rest ecg heart rate < 70 bpm;
boolean
C0018810 (UMLS CUI [1])
sinus rhythm.
Item
no sinus rhythm.
boolean
C0232201 (UMLS CUI [1])
antiarrhythmic drugs
Item
administration of non-dihydropyridinic calcium channels antagonists, digitalis, class i antiarrhythmic drugs, strong inhibitors of cytochrome p450 3a4 at the time of enrollment.
boolean
C0003195 (UMLS CUI [1])

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