ID

4850

Description

Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure (ASTRONAUT) See http://clinicaltrials.gov/ct2/show/record/NCT00894387

Link

http://clinicaltrials.gov/ct2/show/record/NCT00894387

Keywords

  1. 11/18/11 11/18/11 -
  2. 3/26/14 3/26/14 - Martin Dugas
  3. 4/13/14 4/13/14 - Julian Varghese
Uploaded on

April 13, 2014

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT00894387 Heart Failure

Eligibility Heart failure NCT00894387

Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
primary diagnosis of worsening heart failure
Description

Heart failure

Data type

boolean

Alias
UMLS CUI-1
C0018801
age >= 18 years
Description

Age

Data type

boolean

acute heart failure symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization
Description

Heart failure signs and symptoms

Data type

boolean

Alias
UMLS CUI-1
C0851638
LVEF less than 40% (measured within the last 6 months)
Description

LVEF

Data type

boolean

Alias
UMLS CUI-1
C0232174
Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP >= 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization
Description

Hospitalization

Data type

boolean

Alias
UMLS CUI-1
C0019993
Elevated BNP at Visit 1 or at randomization (BNP >= 400 pg/ml)
Description

BNP

Data type

boolean

Alias
UMLS CUI-1
C1095989
Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).
Description

History of heart failure

Data type

boolean

Alias
UMLS CUI-1
C0455531
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI-1
C1514463
Concomitant use of ACEI and ARB at randomization.
Description

Concomitant medication ongoing

Data type

boolean

Alias
UMLS CUI-1
C2826666
Right heart failure due to pulmonary disease.
Description

Pulmonary disease

Data type

boolean

Alias
UMLS CUI-1
C0024115
Diagnosis of postpartum cardiomyopathy.
Description

Cardiomyopathy

Data type

boolean

Alias
UMLS CUI-1
C0878544
Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
Description

Myocardial infarction

Data type

boolean

Alias
UMLS CUI-1
C0027051
Patients with a history of heart transplant or who are on a transplant list.
Description

Heart transplantation

Data type

boolean

Alias
UMLS CUI-1
C0018823
Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.
Description

Coronary artery disease

Data type

boolean

Alias
UMLS CUI-1
C0010068

Similar models

Eligibility Heart failure NCT00894387

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Heart failure
Item
primary diagnosis of worsening heart failure
boolean
C0018801 (UMLS CUI-1)
Age
Item
age >= 18 years
boolean
Heart failure signs and symptoms
Item
acute heart failure symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization
boolean
C0851638 (UMLS CUI-1)
LVEF
Item
LVEF less than 40% (measured within the last 6 months)
boolean
C0232174 (UMLS CUI-1)
Hospitalization
Item
Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP >= 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization
boolean
C0019993 (UMLS CUI-1)
BNP
Item
Elevated BNP at Visit 1 or at randomization (BNP >= 400 pg/ml)
boolean
C1095989 (UMLS CUI-1)
History of heart failure
Item
Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).
boolean
C0455531 (UMLS CUI-1)
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Prior Therapy
Item
Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.
boolean
C1514463 (UMLS CUI-1)
Concomitant medication ongoing
Item
Concomitant use of ACEI and ARB at randomization.
boolean
C2826666 (UMLS CUI-1)
Pulmonary disease
Item
Right heart failure due to pulmonary disease.
boolean
C0024115 (UMLS CUI-1)
Cardiomyopathy
Item
Diagnosis of postpartum cardiomyopathy.
boolean
C0878544 (UMLS CUI-1)
Myocardial infarction
Item
Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
boolean
C0027051 (UMLS CUI-1)
Heart transplantation
Item
Patients with a history of heart transplant or who are on a transplant list.
boolean
C0018823 (UMLS CUI-1)
Coronary artery disease
Item
Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.
boolean
C0010068 (UMLS CUI-1)

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