ID

39492

Descrizione

REDUCE LAP-HF TRIAL; ODM derived from: https://clinicaltrials.gov/show/NCT01913613

collegamento

https://clinicaltrials.gov/show/NCT01913613

Keywords

versioni (1)
  1. 17/01/20 17/01/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

17 gennaio 2020

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01913613

Inglese

Eligibility Heart Failure NCT01913613

1 moduli  
Criteria
Descrizione

Criteria

1. chronic symptomatic heart failure (hf) documented by one or more of the following:
Descrizione

Chronic heart failure Symptomatic

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C0231220
1. new york heart association (nyha) class ii/iii/ambulatory class iv symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months;
Descrizione

Symptoms New York Heart Association Classification | Symptoms Ambulatory New York Heart Association Classification | Paroxysmal nocturnal dyspnea | Orthopnea | Dyspnea on exertion Mild | Dyspnea on exertion Moderate | Signs | Rales Post Cough | Pulmonary congestion Chest X-ray

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1561561
UMLS CUI [2,3]
C1275491
UMLS CUI [3]
C1956415
UMLS CUI [4]
C0085619
UMLS CUI [5,1]
C0231807
UMLS CUI [5,2]
C2945599
UMLS CUI [6,1]
C0231807
UMLS CUI [6,2]
C0205081
UMLS CUI [7]
C0311392
UMLS CUI [8,1]
C0034642
UMLS CUI [8,2]
C0687676
UMLS CUI [8,3]
C0010200
UMLS CUI [9,1]
C0242073
UMLS CUI [9,2]
C0039985
2. one hospital admission for which hf was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
Descrizione

Hospitalization Due to Heart Failure Quantity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3898876
UMLS CUI [1,2]
C1265611
3. on-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 esc guidelines for diagnosis and treatment of acute and chronic heart failure).
Descrizione

Pharmacotherapy Heart failure | Comorbidity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0018801
UMLS CUI [2]
C0009488
2. age ≥ 40 years old
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
3. left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
Descrizione

Left ventricular ejection fraction Echocardiography

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
4. elevated left ventricular filling pressures with a gradient compared to cvp documented by :
Descrizione

Left ventricular filling pressure increased

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1963871
UMLS CUI [1,2]
C0443246
1. pcwp or lvedp at rest ≥ 15 mmhg, and greater than cvp, or
Descrizione

Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure level At rest

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0086879
UMLS CUI [2,1]
C0456190
UMLS CUI [2,2]
C0443144
2. pcwp during supine bike exercise ≥ 25mm hg, and cvp < 20 mm hg
Descrizione

Pulmonary Capillary Wedge Pressure During Exercise stress test using supine bicycle | Measurement of central venous pressure

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0086879
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2059698
UMLS CUI [2]
C0199666
key exclusion criteria:
Descrizione

Exclusion Criteria Main

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
3. severe heart failure defined as:
Descrizione

Heart failure Severe

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205082
1. acc/aha/esc stage d heart failure, non-ambulatory nyha class iv hf;
Descrizione

Heart failure Stage | Heart failure New York Heart Association Classification

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1306673
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
2. fick cardiac index < 2.0 l/min/m2
Descrizione

Left ventricular Cardiac index by Fick method | Right ventricular Cardiac index by Fick method

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0488670
UMLS CUI [2]
C0488679
3. requiring inotropic infusion (continuous or intermittent) within the past 6 months
Descrizione

Requirement Inotropic agent Infusion

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0304509
UMLS CUI [1,3]
C0574032
4. patient is on the cardiac transplant waiting list 4. inability to perform 6 minute walk test 5. known significant coronary artery disease (stenosis >70%) 6. history of stroke, transient ischemic attack (tia), deep vein thrombosis (dvt), or pulmonary emboli within the past 6 months 7. known severe carotid artery stenosis (> 70%) 8. presence of significant valve disease defined by echocardiography as: a) mitral valve regurgitation defined as grade >2+ mr b) tricuspid valve regurgitation defined as grade ≥ 2+ tr; c) aortic valve disease defined as ≥ 2+ ar or moderate as
Descrizione

Patient on waiting list Heart Transplantation | 6-Minute Walk Test Unable | Coronary Artery Disease | Stenosis Percentage | Cerebrovascular accident | Transient Ischemic Attack | Deep Vein Thrombosis | Pulmonary Embolism | Carotid Stenosis Severe Percentage | Valvular disease Echocardiography | Mitral Valve Insufficiency Grade | Tricuspid Valve Insufficiency Grade | Aortic valve disorder | Aortic Valve Insufficiency Grade | Aortic Valve Stenosis Moderate

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0422768
UMLS CUI [1,2]
C0018823
UMLS CUI [2,1]
C0430515
UMLS CUI [2,2]
C1299582
UMLS CUI [3]
C1956346
UMLS CUI [4,1]
C1261287
UMLS CUI [4,2]
C0439165
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
UMLS CUI [7]
C0149871
UMLS CUI [8]
C0034065
UMLS CUI [9,1]
C0007282
UMLS CUI [9,2]
C0205082
UMLS CUI [9,3]
C0439165
UMLS CUI [10,1]
C3258293
UMLS CUI [10,2]
C0013516
UMLS CUI [11,1]
C0026266
UMLS CUI [11,2]
C0441800
UMLS CUI [12,1]
C0040961
UMLS CUI [12,2]
C0441800
UMLS CUI [13]
C1260873
UMLS CUI [14,1]
C0003504
UMLS CUI [14,2]
C0441800
UMLS CUI [15,1]
C0003507
UMLS CUI [15,2]
C0205081
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Similar models

Eligibility Heart Failure NCT01913613

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Chronic heart failure Symptomatic
Item
1. chronic symptomatic heart failure (hf) documented by one or more of the following:
boolean
C0264716 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Symptoms New York Heart Association Classification | Symptoms Ambulatory New York Heart Association Classification | Paroxysmal nocturnal dyspnea | Orthopnea | Dyspnea on exertion Mild | Dyspnea on exertion Moderate | Signs | Rales Post Cough | Pulmonary congestion Chest X-ray
Item
1. new york heart association (nyha) class ii/iii/ambulatory class iv symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months;
boolean
C1457887 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C1561561 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C1956415 (UMLS CUI [3])
C0085619 (UMLS CUI [4])
C0231807 (UMLS CUI [5,1])
C2945599 (UMLS CUI [5,2])
C0231807 (UMLS CUI [6,1])
C0205081 (UMLS CUI [6,2])
C0311392 (UMLS CUI [7])
C0034642 (UMLS CUI [8,1])
C0687676 (UMLS CUI [8,2])
C0010200 (UMLS CUI [8,3])
C0242073 (UMLS CUI [9,1])
C0039985 (UMLS CUI [9,2])
Hospitalization Due to Heart Failure Quantity
Item
2. one hospital admission for which hf was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
boolean
C3898876 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Pharmacotherapy Heart failure | Comorbidity
Item
3. on-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 esc guidelines for diagnosis and treatment of acute and chronic heart failure).
boolean
C0013216 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
Age
Item
2. age ≥ 40 years old
boolean
C0001779 (UMLS CUI [1])
Left ventricular ejection fraction Echocardiography
Item
3. left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Left ventricular filling pressure increased
Item
4. elevated left ventricular filling pressures with a gradient compared to cvp documented by :
boolean
C1963871 (UMLS CUI [1,1])
C0443246 (UMLS CUI [1,2])
Pulmonary Capillary Wedge Pressure | Left ventricular end-diastolic pressure level At rest
Item
1. pcwp or lvedp at rest ≥ 15 mmhg, and greater than cvp, or
boolean
C0086879 (UMLS CUI [1])
C0456190 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
Pulmonary Capillary Wedge Pressure During Exercise stress test using supine bicycle | Measurement of central venous pressure
Item
2. pcwp during supine bike exercise ≥ 25mm hg, and cvp < 20 mm hg
boolean
C0086879 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2059698 (UMLS CUI [1,3])
C0199666 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Heart failure Severe
Item
3. severe heart failure defined as:
boolean
C0018801 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Heart failure Stage | Heart failure New York Heart Association Classification
Item
1. acc/aha/esc stage d heart failure, non-ambulatory nyha class iv hf;
boolean
C0018801 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Left ventricular Cardiac index by Fick method | Right ventricular Cardiac index by Fick method
Item
2. fick cardiac index < 2.0 l/min/m2
boolean
C0488670 (UMLS CUI [1])
C0488679 (UMLS CUI [2])
Requirement Inotropic agent Infusion
Item
3. requiring inotropic infusion (continuous or intermittent) within the past 6 months
boolean
C1514873 (UMLS CUI [1,1])
C0304509 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,3])
Patient on waiting list Heart Transplantation | 6-Minute Walk Test Unable | Coronary Artery Disease | Stenosis Percentage | Cerebrovascular accident | Transient Ischemic Attack | Deep Vein Thrombosis | Pulmonary Embolism | Carotid Stenosis Severe Percentage | Valvular disease Echocardiography | Mitral Valve Insufficiency Grade | Tricuspid Valve Insufficiency Grade | Aortic valve disorder | Aortic Valve Insufficiency Grade | Aortic Valve Stenosis Moderate
Item
4. patient is on the cardiac transplant waiting list 4. inability to perform 6 minute walk test 5. known significant coronary artery disease (stenosis >70%) 6. history of stroke, transient ischemic attack (tia), deep vein thrombosis (dvt), or pulmonary emboli within the past 6 months 7. known severe carotid artery stenosis (> 70%) 8. presence of significant valve disease defined by echocardiography as: a) mitral valve regurgitation defined as grade >2+ mr b) tricuspid valve regurgitation defined as grade ≥ 2+ tr; c) aortic valve disease defined as ≥ 2+ ar or moderate as
boolean
C0422768 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C0430515 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C1956346 (UMLS CUI [3])
C1261287 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0149871 (UMLS CUI [7])
C0034065 (UMLS CUI [8])
C0007282 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0439165 (UMLS CUI [9,3])
C3258293 (UMLS CUI [10,1])
C0013516 (UMLS CUI [10,2])
C0026266 (UMLS CUI [11,1])
C0441800 (UMLS CUI [11,2])
C0040961 (UMLS CUI [12,1])
C0441800 (UMLS CUI [12,2])
C1260873 (UMLS CUI [13])
C0003504 (UMLS CUI [14,1])
C0441800 (UMLS CUI [14,2])
C0003507 (UMLS CUI [15,1])
C0205081 (UMLS CUI [15,2])
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