ID

12193

Description

BioImpedentiometry, Lung UltraSound and cONgestion in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02394470

Link

https://clinicaltrials.gov/show/NCT02394470

Keywords

  1. 10/12/15 10/12/15 -
Uploaded on

October 12, 2015

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Congestive Heart Failure NCT02394470

Eligibility Congestive Heart Failure NCT02394470

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
group-specific inclusion criteria:
Description

inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
1. group 1 (acute heart failure - ahf), patient admitted to the hospital for acute heart failure (de-novo or exacerbation of chronic heart failure), who have at least two of the following congestion criteria:
Description

Acute heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0264714
weight gain ≥ 2 kg over the three days prior to hospitalization
Description

weight gain

Data type

boolean

Alias
UMLS CUI [1]
C0043094
physical findings or radiographic signs of pulmonary congestion (crackles, semi-orthopnea)
Description

pulmonary congestion

Data type

boolean

Alias
UMLS CUI [1]
C0242073
hepatomegaly > 2 cm from the arch rib or ascites
Description

hepatomegaly

Data type

boolean

Alias
UMLS CUI [1]
C0019209
jugular turgor or central venous pressure > 10 cm h20
Description

central venous pressure

Data type

boolean

Alias
UMLS CUI [1]
C0428640
ankle swelling
Description

ankle swelling

Data type

boolean

Alias
UMLS CUI [1]
C0235439
2. group 2 (chronic heart failure - chf): outpatients with chronic heart failure (chf) with characters of clinical stability
Description

Chronic heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0264716
no hospitalization in the previous six months
Description

hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0019993
symptoms stable for at least 4 weeks
Description

symptoms; stable

Data type

boolean

Alias
UMLS CUI [1]
C1457887
UMLS CUI [2]
C0205360
oral therapy stable for at least 4 weeks
Description

therapy; stable; oral

Data type

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0205360
UMLS CUI [3]
C0442027
no involuntary weight variations greater than 2 kg in the last 4 weeks
Description

weight gain

Data type

boolean

Alias
UMLS CUI [1]
C0043094
absence of signs of congestion
Description

congestion

Data type

boolean

Alias
UMLS CUI [1]
C0700148
3. group 3 (advanced chronic heart failure - ad-chf) patients on optimal medical therapy for hf and treated with periodic infusions of levosimendan (every 4 weeks) according to the following criteria
Description

chronic heart failure Advanced phase

Data type

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C0205179
systolic dysfunction (lvef <35%)
Description

systolic dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0749225
nyha class iiib-iv and/or level intermacs 4, 5, 6
Description

nyha class

Data type

boolean

Alias
UMLS CUI [1]
C1275491
≥2 admissions or access to the emergency department for acute hf exacerbation in the previous 12 months
Description

acute heart failure; exacerbation

Data type

boolean

Alias
UMLS CUI [1]
C0264714
UMLS CUI [2]
C0235874
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uremia in dialysis treatment
Description

uremia; dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0041948
UMLS CUI [2]
C0011946
invasive mechanical ventilation
Description

invasive mechanical ventilation

Data type

boolean

Alias
UMLS CUI [1]
C1868981
mechanical circulatory support
Description

mechanical circulatory support

Data type

boolean

Alias
UMLS CUI [1]
C3274791
cardiac cachexia defined as weight loss ≥ 5% in the prior 12 months or body mass index <20 kg/m2 and hypoalbuminemia (albumin <3.2 g/dl) or anemia (hemoglobin <12 g/l)
Description

cardiac cachexia

Data type

boolean

Alias
UMLS CUI [1]
C0562491

Similar models

Eligibility Congestive Heart Failure NCT02394470

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
inclusion criteria
Item
group-specific inclusion criteria:
boolean
C1512693 (UMLS CUI [1])
Acute heart failure
Item
1. group 1 (acute heart failure - ahf), patient admitted to the hospital for acute heart failure (de-novo or exacerbation of chronic heart failure), who have at least two of the following congestion criteria:
boolean
C0264714 (UMLS CUI [1])
weight gain
Item
weight gain ≥ 2 kg over the three days prior to hospitalization
boolean
C0043094 (UMLS CUI [1])
pulmonary congestion
Item
physical findings or radiographic signs of pulmonary congestion (crackles, semi-orthopnea)
boolean
C0242073 (UMLS CUI [1])
hepatomegaly
Item
hepatomegaly > 2 cm from the arch rib or ascites
boolean
C0019209 (UMLS CUI [1])
central venous pressure
Item
jugular turgor or central venous pressure > 10 cm h20
boolean
C0428640 (UMLS CUI [1])
ankle swelling
Item
ankle swelling
boolean
C0235439 (UMLS CUI [1])
Chronic heart failure
Item
2. group 2 (chronic heart failure - chf): outpatients with chronic heart failure (chf) with characters of clinical stability
boolean
C0264716 (UMLS CUI [1])
hospitalization
Item
no hospitalization in the previous six months
boolean
C0019993 (UMLS CUI [1])
symptoms; stable
Item
symptoms stable for at least 4 weeks
boolean
C1457887 (UMLS CUI [1])
C0205360 (UMLS CUI [2])
therapy; stable; oral
Item
oral therapy stable for at least 4 weeks
boolean
C0087111 (UMLS CUI [1])
C0205360 (UMLS CUI [2])
C0442027 (UMLS CUI [3])
weight gain
Item
no involuntary weight variations greater than 2 kg in the last 4 weeks
boolean
C0043094 (UMLS CUI [1])
congestion
Item
absence of signs of congestion
boolean
C0700148 (UMLS CUI [1])
chronic heart failure Advanced phase
Item
3. group 3 (advanced chronic heart failure - ad-chf) patients on optimal medical therapy for hf and treated with periodic infusions of levosimendan (every 4 weeks) according to the following criteria
boolean
C0264716 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
systolic dysfunction
Item
systolic dysfunction (lvef <35%)
boolean
C0749225 (UMLS CUI [1])
nyha class
Item
nyha class iiib-iv and/or level intermacs 4, 5, 6
boolean
C1275491 (UMLS CUI [1])
acute heart failure; exacerbation
Item
≥2 admissions or access to the emergency department for acute hf exacerbation in the previous 12 months
boolean
C0264714 (UMLS CUI [1])
C0235874 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
uremia; dialysis
Item
uremia in dialysis treatment
boolean
C0041948 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
invasive mechanical ventilation
Item
invasive mechanical ventilation
boolean
C1868981 (UMLS CUI [1])
mechanical circulatory support
Item
mechanical circulatory support
boolean
C3274791 (UMLS CUI [1])
cardiac cachexia
Item
cardiac cachexia defined as weight loss ≥ 5% in the prior 12 months or body mass index <20 kg/m2 and hypoalbuminemia (albumin <3.2 g/dl) or anemia (hemoglobin <12 g/l)
boolean
C0562491 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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