ID

39394

Description

A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01125514

Link

https://clinicaltrials.gov/show/NCT01125514

Keywords

Versions (1)
  1. 1/7/20 1/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01125514

English

Eligibility Heart Failure NCT01125514

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
systolic or diastolic heart failure, diagnosed with either nyha functional class ii to iii at least 3 months prior to screening and on stable medication for at least 12 weeks.
Description

Systolic Heart Failure Disease length New York Heart Association Classification | Diastolic Heart Failure Disease length New York Heart Association Classification | Pharmaceutical Preparations Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C1135191
UMLS CUI [1,2]
C0872146
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C1135196
UMLS CUI [2,2]
C0872146
UMLS CUI [2,3]
C1275491
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0205360
patients must have met either of the criteria at screening:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
documented left ventricular ejection fraction (lvef) greater than 20% but lower than 40% or
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
patients with a documented lvef greater than 40% and with a history of nt-pro-bnp> 400pg/ml (or bnp > 100pg/ml) within 12 months of screening.
Description

Left ventricular ejection fraction | Amino-terminal pro-brain natriuretic peptide Unit of Measurement | Brain natriuretic peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C0754710
UMLS CUI [2,2]
C1519795
UMLS CUI [3]
C1095989
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with angiotensin receptor blockers (arbs), aldosterone receptor antagonists and diuretics (other than furosemide) within 3 weeks of first dose and during the study. beta blockers were permitted provided the dose was stable for at least 3 weeks before the first dose and remains so throughout the study.
Description

Angiotensin II receptor antagonist | Aldosterone Receptor Antagonists | Diuretics | Exception Furosemide

Data type

boolean

Alias
UMLS CUI [1]
C0521942
UMLS CUI [2]
C1579268
UMLS CUI [3]
C0012798
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0016860
hypertrophic cardiomyopathy (hcmp).
Description

Hypertrophic Cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0007194
if a subject is currently treated with furosemide, the dose must be stable for at least 3 weeks before the first dose and the dose must not exceed 60 mg daily
Description

Furosemide Dose Stable U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0016860
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
stable heart failure requiring treatment with both an ace inhibitor and an arb or current acute decompensated heart failure.
Description

Heart failure Stable | Requirement Angiotensin-Converting Enzyme Inhibitors | Requirement Angiotensin II receptor antagonist | Decompensated cardiac failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0003015
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0521942
UMLS CUI [4]
C0581377
mean sitting systolic blood pressure ≥160 mmhg and/or mean sitting diastolic blood pressure ≥ 100mmhg and/or secondary forms of hypertension.
Description

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3]
C0155616
persistent sitting systolic blood pressure <90 mmhg.
Description

Sitting systolic blood pressure Persistent

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0205322
history of angioedema.
Description

Angioedema

Data type

boolean

Alias
UMLS CUI [1]
C0002994
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Heart Failure NCT01125514

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Systolic Heart Failure Disease length New York Heart Association Classification | Diastolic Heart Failure Disease length New York Heart Association Classification | Pharmaceutical Preparations Stable
Item
systolic or diastolic heart failure, diagnosed with either nyha functional class ii to iii at least 3 months prior to screening and on stable medication for at least 12 weeks.
boolean
C1135191 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C1135196 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Criteria Fulfill
Item
patients must have met either of the criteria at screening:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
documented left ventricular ejection fraction (lvef) greater than 20% but lower than 40% or
boolean
C0428772 (UMLS CUI [1])
Left ventricular ejection fraction | Amino-terminal pro-brain natriuretic peptide Unit of Measurement | Brain natriuretic peptide measurement
Item
patients with a documented lvef greater than 40% and with a history of nt-pro-bnp> 400pg/ml (or bnp > 100pg/ml) within 12 months of screening.
boolean
C0428772 (UMLS CUI [1])
C0754710 (UMLS CUI [2,1])
C1519795 (UMLS CUI [2,2])
C1095989 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Angiotensin II receptor antagonist | Aldosterone Receptor Antagonists | Diuretics | Exception Furosemide
Item
treatment with angiotensin receptor blockers (arbs), aldosterone receptor antagonists and diuretics (other than furosemide) within 3 weeks of first dose and during the study. beta blockers were permitted provided the dose was stable for at least 3 weeks before the first dose and remains so throughout the study.
boolean
C0521942 (UMLS CUI [1])
C1579268 (UMLS CUI [2])
C0012798 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0016860 (UMLS CUI [4,2])
Hypertrophic Cardiomyopathy
Item
hypertrophic cardiomyopathy (hcmp).
boolean
C0007194 (UMLS CUI [1])
Furosemide Dose Stable U/day
Item
if a subject is currently treated with furosemide, the dose must be stable for at least 3 weeks before the first dose and the dose must not exceed 60 mg daily
boolean
C0016860 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Heart failure Stable | Requirement Angiotensin-Converting Enzyme Inhibitors | Requirement Angiotensin II receptor antagonist | Decompensated cardiac failure
Item
stable heart failure requiring treatment with both an ace inhibitor and an arb or current acute decompensated heart failure.
boolean
C0018801 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0003015 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0521942 (UMLS CUI [3,2])
C0581377 (UMLS CUI [4])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Secondary hypertension
Item
mean sitting systolic blood pressure ≥160 mmhg and/or mean sitting diastolic blood pressure ≥ 100mmhg and/or secondary forms of hypertension.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0155616 (UMLS CUI [3])
Sitting systolic blood pressure Persistent
Item
persistent sitting systolic blood pressure <90 mmhg.
boolean
C1319893 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
Angioedema
Item
history of angioedema.
boolean
C0002994 (UMLS CUI [1])
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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