ID

27808

Descrição

Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbi-mortality in Patients With Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00853658

Link

https://clinicaltrials.gov/show/NCT00853658

Palavras-chave

Versões (1)
  1. 29/11/2017 29/11/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

29 de novembro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Heart Failure NCT00853658

Inglês

Eligibility Chronic Heart Failure NCT00853658

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a diagnosis of chronic heart failure (nyha class ii - iv):
Descrição

Chronic heart failure New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C1275491
lvef ≤ 35% at visit 1. (local measurement, measured within the past 6 months assessed by echocardiogram, muga, ct scan, mri or ventricular angiography)
Descrição

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA | Left ventricular ejection fraction CT scan | Left ventricular ejection fraction MRI | Left ventricular ejection fraction Ventricular angiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
UMLS CUI [3,1]
C0428772
UMLS CUI [3,2]
C0040405
UMLS CUI [4,1]
C0428772
UMLS CUI [4,2]
C0024485
UMLS CUI [5,1]
C0428772
UMLS CUI [5,2]
C1112786
elevated bnp at visit 1: bnp ≥ 150 pg/ml (according to local measurement).
Descrição

Brain natriuretic peptide increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1095988
bnp ≥ 100 pg/ml (according to local measurement) and unplanned hospitalization with hf within the last 12 months prior visit 1.
Descrição

Brain natriuretic peptide measurement | Hospitalization Due to Heart Failure Without Plan

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2,1]
C3898876
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C1301732
patients must be treated with an ace inhibitor at a stable dose (enalapril 10 mg daily at least or any other ace inhibitor, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses as described in the dose equivalence guidance table of acei's) for at least 4 weeks prior to visit 1
Descrição

Angiotensin-Converting Enzyme Inhibitors Dose Stable | Enalapril U/day | Ramipril | quinapril | Lisinopril | Fosinopril | Perindopril | trandolapril

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003015
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0014025
UMLS CUI [2,2]
C0456683
UMLS CUI [3]
C0072973
UMLS CUI [4]
C0072857
UMLS CUI [5]
C0065374
UMLS CUI [6]
C0118168
UMLS CUI [7]
C0136123
UMLS CUI [8]
C0076891
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of hypersensitivity to any of the study drugs including history or allergy to acei's as well as known or suspected contraindications to the study drugs or previous history of intolerance to high doses of acei's during up titration process.
Descrição

Hypersensitivity Investigational New Drugs | Angiotensin-converting-enzyme inhibitor allergy | Medical contraindication Investigational New Drugs | Medical contraindication Suspected Investigational New Drugs | intolerance to Angiotensin-Converting Enzyme Inhibitors High dose

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2]
C0571939
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0013230
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013230
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0003015
UMLS CUI [5,3]
C0444956
patients treated concomitantly with both arb and aldosterone antagonist in addition to study drug at visit 1.
Descrição

Angiotensin II receptor antagonist | Aldosterone Antagonists | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0521942
UMLS CUI [2]
C0002007
UMLS CUI [3]
C0013230
current acute decompensated hf.
Descrição

Decompensated cardiac failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0581377
symptomatic hypotension and/or less than 95 mmhg sbp at visit 1 and/or less than 90 mmhg at visit 4.
Descrição

Hypotension symptomatic | Systolic Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0863113
UMLS CUI [2]
C0871470
renal disease likely to be life threatening or egfr < 40 ml/min/1.73m2 as measured by the mdrd formula at visit 1 and egfr < 35 ml/min/1.73m2 as measured by the mdrd formula at visit 4 or decrease of egfr of more than 25% from visit 1 to visit 4 (according to local laboratory measurement).
Descrição

Kidney Disease Life Threatening | Estimated Glomerular Filtration Rate Creatinine-based formula (MDRD) | Decreased glomerular filtration rate Percentage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C2826244
UMLS CUI [2,1]
C3811844
UMLS CUI [2,2]
C1980036
UMLS CUI [3,1]
C0853068
UMLS CUI [3,2]
C0439165
serum potassium ≥ 5.0 mmol/l at visit 1 or ≥ 5.2 mmol/l at visit 4 (according to local laboratory measurement).
Descrição

Serum potassium measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0302353
acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (pci) or carotid angioplasty, within the past 3 months prior to visit 1.
Descrição

Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiac Surgery procedures | Carotid surgery | Vascular Surgical Procedures Major | Percutaneous Coronary Intervention | Carotid angioplasty

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0018821
UMLS CUI [5]
C0741984
UMLS CUI [6,1]
C0042381
UMLS CUI [6,2]
C0205164
UMLS CUI [7]
C1532338
UMLS CUI [8]
C3203476
coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after visit 1.
Descrição

Coronary Artery Disease Requirement Operative Surgical Procedures | Carotid Artery Disease Requirement Operative Surgical Procedures | Coronary Artery Disease Requirement Intervention Percutaneous | Carotid Artery Disease Requirement Intervention Percutaneous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0007273
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0184661
UMLS CUI [3,4]
C0522523
UMLS CUI [4,1]
C0007273
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0184661
UMLS CUI [4,4]
C0522523
right heart failure due to severe pulmonary disease
Descrição

Right Heart Failure Due to Lung disease Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0235527
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0024115
UMLS CUI [1,4]
C0205082
other protocol-defined inclusion/exclusion criteria may apply
Descrição

Eligibility Criteria Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Eligibility Chronic Heart Failure NCT00853658

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Chronic heart failure New York Heart Association Classification
Item
patients with a diagnosis of chronic heart failure (nyha class ii - iv):
boolean
C0264716 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA | Left ventricular ejection fraction CT scan | Left ventricular ejection fraction MRI | Left ventricular ejection fraction Ventricular angiography
Item
lvef ≤ 35% at visit 1. (local measurement, measured within the past 6 months assessed by echocardiogram, muga, ct scan, mri or ventricular angiography)
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C0428772 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0428772 (UMLS CUI [5,1])
C1112786 (UMLS CUI [5,2])
Brain natriuretic peptide increased
Item
elevated bnp at visit 1: bnp ≥ 150 pg/ml (according to local measurement).
boolean
C1095988 (UMLS CUI [1])
Brain natriuretic peptide measurement | Hospitalization Due to Heart Failure Without Plan
Item
bnp ≥ 100 pg/ml (according to local measurement) and unplanned hospitalization with hf within the last 12 months prior visit 1.
boolean
C1095989 (UMLS CUI [1])
C3898876 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Angiotensin-Converting Enzyme Inhibitors Dose Stable | Enalapril U/day | Ramipril | quinapril | Lisinopril | Fosinopril | Perindopril | trandolapril
Item
patients must be treated with an ace inhibitor at a stable dose (enalapril 10 mg daily at least or any other ace inhibitor, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses as described in the dose equivalence guidance table of acei's) for at least 4 weeks prior to visit 1
boolean
C0003015 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0014025 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0072973 (UMLS CUI [3])
C0072857 (UMLS CUI [4])
C0065374 (UMLS CUI [5])
C0118168 (UMLS CUI [6])
C0136123 (UMLS CUI [7])
C0076891 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Angiotensin-converting-enzyme inhibitor allergy | Medical contraindication Investigational New Drugs | Medical contraindication Suspected Investigational New Drugs | intolerance to Angiotensin-Converting Enzyme Inhibitors High dose
Item
history of hypersensitivity to any of the study drugs including history or allergy to acei's as well as known or suspected contraindications to the study drugs or previous history of intolerance to high doses of acei's during up titration process.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0571939 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
C1744706 (UMLS CUI [5,1])
C0003015 (UMLS CUI [5,2])
C0444956 (UMLS CUI [5,3])
Angiotensin II receptor antagonist | Aldosterone Antagonists | Investigational New Drugs
Item
patients treated concomitantly with both arb and aldosterone antagonist in addition to study drug at visit 1.
boolean
C0521942 (UMLS CUI [1])
C0002007 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Decompensated cardiac failure
Item
current acute decompensated hf.
boolean
C0581377 (UMLS CUI [1])
Hypotension symptomatic | Systolic Pressure
Item
symptomatic hypotension and/or less than 95 mmhg sbp at visit 1 and/or less than 90 mmhg at visit 4.
boolean
C0863113 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Kidney Disease Life Threatening | Estimated Glomerular Filtration Rate Creatinine-based formula (MDRD) | Decreased glomerular filtration rate Percentage
Item
renal disease likely to be life threatening or egfr < 40 ml/min/1.73m2 as measured by the mdrd formula at visit 1 and egfr < 35 ml/min/1.73m2 as measured by the mdrd formula at visit 4 or decrease of egfr of more than 25% from visit 1 to visit 4 (according to local laboratory measurement).
boolean
C0022658 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2,1])
C1980036 (UMLS CUI [2,2])
C0853068 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Serum potassium measurement
Item
serum potassium ≥ 5.0 mmol/l at visit 1 or ≥ 5.2 mmol/l at visit 4 (according to local laboratory measurement).
boolean
C0302353 (UMLS CUI [1])
Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiac Surgery procedures | Carotid surgery | Vascular Surgical Procedures Major | Percutaneous Coronary Intervention | Carotid angioplasty
Item
acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (pci) or carotid angioplasty, within the past 3 months prior to visit 1.
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0018821 (UMLS CUI [4])
C0741984 (UMLS CUI [5])
C0042381 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C1532338 (UMLS CUI [7])
C3203476 (UMLS CUI [8])
Coronary Artery Disease Requirement Operative Surgical Procedures | Carotid Artery Disease Requirement Operative Surgical Procedures | Coronary Artery Disease Requirement Intervention Percutaneous | Carotid Artery Disease Requirement Intervention Percutaneous
Item
coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after visit 1.
boolean
C1956346 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0007273 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C1956346 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0184661 (UMLS CUI [3,3])
C0522523 (UMLS CUI [3,4])
C0007273 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0184661 (UMLS CUI [4,3])
C0522523 (UMLS CUI [4,4])
Right Heart Failure Due to Lung disease Severe
Item
right heart failure due to severe pulmonary disease
boolean
C0235527 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0024115 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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