ID

39459

Beschreibung

Observatory: Search for Prognostic Factors of Pulmonary Hypertension Post-capillary in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01545180

Link

https://clinicaltrials.gov/show/NCT01545180

Stichworte

Versionen (1)
  1. 12.01.20 12.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

12. Januar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01545180

Englisch

Eligibility Heart Failure NCT01545180

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with heart failure (lvef preserved or altered or valvular heart disease) defined by a history of heart failure or lvef less than or equal to 50%.
Beschreibung

Heart failure with preserved ejection fraction | Heart failure Left ventricular ejection fraction altered | Heart valve disease | Heart failure | Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C4509226
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0428772
UMLS CUI [2,3]
C0392747
UMLS CUI [3]
C0018824
UMLS CUI [4]
C0018801
UMLS CUI [5]
C0428772
patient with a right heart catheterization for medical reasons
Beschreibung

Catheterization of right heart

Datentyp

boolean

Alias
UMLS CUI [1]
C0189896
medical treatment considered optimal: beta blockers, ace inhibitors or angiotensin ii receptor antagonists and/or aldosterone
Beschreibung

Therapy Optimal | Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Aldosterone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [2]
C0304516
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
UMLS CUI [5]
C0002006
stable patient: no significant cardiac decompensation or change the dose of diuretics for 28 days.
Beschreibung

Patient Stable | Heart Decompensation Absent | Diuretics Dose unchanged

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C1961112
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0012798
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0442739
the patient has agreed and have signed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is younger than 18 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patient with unstable heart failure (cardiogenic shock, acute cardiac decompensation).
Beschreibung

Heart failure Unstable | Shock, Cardiogenic | Heart Decompensation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0036980
UMLS CUI [3]
C1961112
coronary heart disease for which there is a maximum revascularization
Beschreibung

Coronary heart disease | Revascularization Maximum

Datentyp

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2,1]
C0581603
UMLS CUI [2,2]
C0806909
organic valvular which is scheduled for surgical correction of valvular abnormality (plasty or replacement).
Beschreibung

Organic heart disease Valve | Correction Surgical Valvular abnormality | Repair of heart valve | Valve replacement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0747057
UMLS CUI [1,2]
C1186983
UMLS CUI [2,1]
C1947976
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0241654
UMLS CUI [3]
C0190112
UMLS CUI [4]
C1410969
patient dialysis.
Beschreibung

Dialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011946
pah original pre-capillary catheterization, defined by a pcap ≤ 15 mmhg.
Beschreibung

Pulmonary arterial hypertension | Catheterization

Datentyp

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2]
C0007430
patient with triple installation of pm within 90 days.
Beschreibung

Other Coding

Datentyp

boolean

Alias
UMLS CUI [1]
C3846158
patients who underwent revascularization within 90 days.
Beschreibung

Revascularization

Datentyp

boolean

Alias
UMLS CUI [1]
C0581603
patients who underwent mechanical ventricular assistance.
Beschreibung

Mechanical assistance Ventricular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0456150
UMLS CUI [1,2]
C0018827
patient with severe lung infection (cpt < 60% of predicted, fev < 60% predicted) or pulmonary embolism or respiratory failure with a pao2 in ambient air below 60mmhg or oxygen therapy.
Beschreibung

Infectious disease of lung Severe | Percent Predicted Forced Vital Capacity | Percent predicted FEV1 | Pulmonary Embolism | Respiratory Failure | PaO2 | Oxygen Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0876973
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3828596
UMLS CUI [3]
C0730561
UMLS CUI [4]
C0034065
UMLS CUI [5]
C1145670
UMLS CUI [6]
C0202155
UMLS CUI [7]
C0184633
patient with severe heart rhythm.
Beschreibung

Heart rhythm Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232187
UMLS CUI [1,2]
C0205082
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Ähnliche Modelle

Eligibility Heart Failure NCT01545180

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure with preserved ejection fraction | Heart failure Left ventricular ejection fraction altered | Heart valve disease | Heart failure | Left ventricular ejection fraction
Item
patient with heart failure (lvef preserved or altered or valvular heart disease) defined by a history of heart failure or lvef less than or equal to 50%.
boolean
C4509226 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C0428772 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0018824 (UMLS CUI [3])
C0018801 (UMLS CUI [4])
C0428772 (UMLS CUI [5])
Catheterization of right heart
Item
patient with a right heart catheterization for medical reasons
boolean
C0189896 (UMLS CUI [1])
Therapy Optimal | Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Aldosterone
Item
medical treatment considered optimal: beta blockers, ace inhibitors or angiotensin ii receptor antagonists and/or aldosterone
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0304516 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C0002006 (UMLS CUI [5])
Patient Stable | Heart Decompensation Absent | Diuretics Dose unchanged
Item
stable patient: no significant cardiac decompensation or change the dose of diuretics for 28 days.
boolean
C0030705 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1961112 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0012798 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
Informed Consent
Item
the patient has agreed and have signed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
patient is younger than 18 years.
boolean
C0001779 (UMLS CUI [1])
Heart failure Unstable | Shock, Cardiogenic | Heart Decompensation
Item
patient with unstable heart failure (cardiogenic shock, acute cardiac decompensation).
boolean
C0018801 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0036980 (UMLS CUI [2])
C1961112 (UMLS CUI [3])
Coronary heart disease | Revascularization Maximum
Item
coronary heart disease for which there is a maximum revascularization
boolean
C0010068 (UMLS CUI [1])
C0581603 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
Organic heart disease Valve | Correction Surgical Valvular abnormality | Repair of heart valve | Valve replacement
Item
organic valvular which is scheduled for surgical correction of valvular abnormality (plasty or replacement).
boolean
C0747057 (UMLS CUI [1,1])
C1186983 (UMLS CUI [1,2])
C1947976 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0241654 (UMLS CUI [2,3])
C0190112 (UMLS CUI [3])
C1410969 (UMLS CUI [4])
Dialysis
Item
patient dialysis.
boolean
C0011946 (UMLS CUI [1])
Pulmonary arterial hypertension | Catheterization
Item
pah original pre-capillary catheterization, defined by a pcap ≤ 15 mmhg.
boolean
C2973725 (UMLS CUI [1])
C0007430 (UMLS CUI [2])
Other Coding
Item
patient with triple installation of pm within 90 days.
boolean
C3846158 (UMLS CUI [1])
Revascularization
Item
patients who underwent revascularization within 90 days.
boolean
C0581603 (UMLS CUI [1])
Mechanical assistance Ventricular
Item
patients who underwent mechanical ventricular assistance.
boolean
C0456150 (UMLS CUI [1,1])
C0018827 (UMLS CUI [1,2])
Infectious disease of lung Severe | Percent Predicted Forced Vital Capacity | Percent predicted FEV1 | Pulmonary Embolism | Respiratory Failure | PaO2 | Oxygen Therapy
Item
patient with severe lung infection (cpt < 60% of predicted, fev < 60% predicted) or pulmonary embolism or respiratory failure with a pao2 in ambient air below 60mmhg or oxygen therapy.
boolean
C0876973 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3828596 (UMLS CUI [2])
C0730561 (UMLS CUI [3])
C0034065 (UMLS CUI [4])
C1145670 (UMLS CUI [5])
C0202155 (UMLS CUI [6])
C0184633 (UMLS CUI [7])
Heart rhythm Severe
Item
patient with severe heart rhythm.
boolean
C0232187 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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