ID

12193

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02394470

Nyckelord

  1. 2015-10-12 2015-10-12 -
Uppladdad den

12 oktober 2015

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Congestive Heart Failure NCT02394470

Eligibility Congestive Heart Failure NCT02394470

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent
Beskrivning

informed consent

Datatyp

boolean

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

inclusion criteria

Datatyp

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:
Beskrivning

Acute heart failure

Datatyp

boolean

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

weight gain

Datatyp

boolean

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

pulmonary congestion

Datatyp

boolean

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

hepatomegaly

Datatyp

boolean

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

central venous pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0428640
ankle swelling
Beskrivning

ankle swelling

Datatyp

boolean

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

Chronic heart failure

Datatyp

boolean

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

hospitalization

Datatyp

boolean

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

symptoms; stable

Datatyp

boolean

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

therapy; stable; oral

Datatyp

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
Beskrivning

weight gain

Datatyp

boolean

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

congestion

Datatyp

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
Beskrivning

chronic heart failure Advanced phase

Datatyp

boolean

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

systolic dysfunction

Datatyp

boolean

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

nyha class

Datatyp

boolean

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

acute heart failure; exacerbation

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
uremia in dialysis treatment
Beskrivning

uremia; dialysis

Datatyp

boolean

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

invasive mechanical ventilation

Datatyp

boolean

Alias
UMLS CUI [1]
C1868981
mechanical circulatory support
Beskrivning

mechanical circulatory support

Datatyp

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)
Beskrivning

cardiac cachexia

Datatyp

boolean

Alias
UMLS CUI [1]
C0562491

Similar models

Eligibility Congestive Heart Failure NCT02394470

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

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