ID

12193

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02394470

Palabras clave

Versiones (1)
  1. 12/10/15 12/10/15 -
Subido en

12 de octubre de 2015

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT02394470

Inglés

Eligibility Congestive Heart Failure NCT02394470

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent
Descripción

informed consent

Tipo de datos

boolean

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

inclusion criteria

Tipo de datos

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:
Descripción

Acute heart failure

Tipo de datos

boolean

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

weight gain

Tipo de datos

boolean

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

pulmonary congestion

Tipo de datos

boolean

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

hepatomegaly

Tipo de datos

boolean

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

central venous pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428640
ankle swelling
Descripción

ankle swelling

Tipo de datos

boolean

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

Chronic heart failure

Tipo de datos

boolean

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

hospitalization

Tipo de datos

boolean

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

symptoms; stable

Tipo de datos

boolean

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

therapy; stable; oral

Tipo de datos

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
Descripción

weight gain

Tipo de datos

boolean

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

congestion

Tipo de datos

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
Descripción

chronic heart failure Advanced phase

Tipo de datos

boolean

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

systolic dysfunction

Tipo de datos

boolean

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

nyha class

Tipo de datos

boolean

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

acute heart failure; exacerbation

Tipo de datos

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
uremia in dialysis treatment
Descripción

uremia; dialysis

Tipo de datos

boolean

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

invasive mechanical ventilation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1868981
mechanical circulatory support
Descripción

mechanical circulatory support

Tipo de datos

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)
Descripción

cardiac cachexia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0562491
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Similar models

Eligibility Congestive Heart Failure NCT02394470

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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