ID

12986

Beschrijving

Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00343902

Link

https://clinicaltrials.gov/show/NCT00343902

Trefwoorden

  1. 10-01-16 10-01-16 -
Geüploaded op

10 januari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Chronic Heart Failure NCT00343902

Eligibility Chronic Heart Failure NCT00343902

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
ambulatory individuals 18 years and older who had been diagnosed with chf (nyha functional classes ii-iv) for > 3 months
Beschrijving

age, ambulation, nyha

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0080331
UMLS CUI [3]
C1275491
left ventricular ejection fraction (lvef) of ≤ 40 percent
Beschrijving

left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
receiving indicated standard therapy (if not contraindicated or intolerant for > 3 months) defined as a diuretic, an ace-inhibitor or an angiotensin receptor blocker (arb) and a beta-blocke
Beschrijving

medication

Datatype

boolean

Alias
UMLS CUI [1]
C0013227
patients with nyha class iii or iv symptoms were also required to receive spironolactone. doses of these drugs had to be stable for ≥ 3 months, except for diuretics, for which ≥ 1 month of stability was required.
Beschrijving

nyha, spironolactone, diuretics

Datatype

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0037982
UMLS CUI [3]
C0012798
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
hemodynamically severe uncorrected primary valvular disease
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0012798
active myocarditis
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0027059
hypertrophic cardiomyopathy
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0007194
restrictive cardiomyopathy
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0007196
myocardial infarction, stroke, unstable angina, coronary artery bypass graft surgery, valvular surgery, or angioplasty < 3 months before randomization
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0007222
symptomatic or sustained ventricular tachycardia not controlled by antiarrhythmic drugs or an implantable cardioverter-defibrillator
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0042514
any condition other than heart failure that would be expected to limit exercise (e.g., angina, peripheral vascular disease, pulmonary disease, arthritis, or an orthopedic problem severe enough to limit exercise)
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
nursing mothers, pregnant women and those planning a pregnancy during the study period
Beschrijving

pregnancy, breastfeeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Chronic Heart Failure NCT00343902

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age, ambulation, nyha
Item
ambulatory individuals 18 years and older who had been diagnosed with chf (nyha functional classes ii-iv) for > 3 months
boolean
C0001779 (UMLS CUI [1])
C0080331 (UMLS CUI [2])
C1275491 (UMLS CUI [3])
left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) of ≤ 40 percent
boolean
C0428772 (UMLS CUI [1])
medication
Item
receiving indicated standard therapy (if not contraindicated or intolerant for > 3 months) defined as a diuretic, an ace-inhibitor or an angiotensin receptor blocker (arb) and a beta-blocke
boolean
C0013227 (UMLS CUI [1])
nyha, spironolactone, diuretics
Item
patients with nyha class iii or iv symptoms were also required to receive spironolactone. doses of these drugs had to be stable for ≥ 3 months, except for diuretics, for which ≥ 1 month of stability was required.
boolean
C1275491 (UMLS CUI [1])
C0037982 (UMLS CUI [2])
C0012798 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
hemodynamically severe uncorrected primary valvular disease
boolean
C0009488 (UMLS CUI [1,1])
C0012798 (UMLS CUI [1,2])
comorbidity
Item
active myocarditis
boolean
C0009488 (UMLS CUI [1,1])
C0027059 (UMLS CUI [1,2])
comorbidity
Item
hypertrophic cardiomyopathy
boolean
C0009488 (UMLS CUI [1,1])
C0007194 (UMLS CUI [1,2])
comorbidity
Item
restrictive cardiomyopathy
boolean
C0009488 (UMLS CUI [1,1])
C0007196 (UMLS CUI [1,2])
comorbidity
Item
myocardial infarction, stroke, unstable angina, coronary artery bypass graft surgery, valvular surgery, or angioplasty < 3 months before randomization
boolean
C0009488 (UMLS CUI [1,1])
C0007222 (UMLS CUI [1,2])
comorbidity
Item
symptomatic or sustained ventricular tachycardia not controlled by antiarrhythmic drugs or an implantable cardioverter-defibrillator
boolean
C0009488 (UMLS CUI [1,1])
C0042514 (UMLS CUI [1,2])
comorbidity
Item
any condition other than heart failure that would be expected to limit exercise (e.g., angina, peripheral vascular disease, pulmonary disease, arthritis, or an orthopedic problem severe enough to limit exercise)
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
pregnancy, breastfeeding
Item
nursing mothers, pregnant women and those planning a pregnancy during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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