ID

13647

Descrição

Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Congestive Heart Failure (PREVENT-CHF): A Phase IIB Randomized Placebo-Controlled Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01347970

Link

https://clinicaltrials.gov/show/NCT01347970

Palavras-chave

Versões (1)
  1. 22/02/2016 22/02/2016 -
Transferido a

22 de fevereiro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Cancer Survivor NCT01347970

Inglês

Eligibility Cancer Survivor NCT01347970

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
cancer diagnosis prior to 22 years of age, irrespective of current age
Descrição

diagnosis cancer; age

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0006826
UMLS CUI [2]
C0001779
lifetime cumulative anthracycline dose: >= 300 mg/m^2 without the protection of dexrazoxane (zinecard) therapy
Descrição

dose anthracycline; dexrazoxane

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0282564
UMLS CUI [2]
C0086444
time from completion of cancer treatment to study entry: >= 2 years
Descrição

cancer treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
receiving treatment for cardiomyopathy or congestive heart failure
Descrição

treatment cardiomyopathy; treatment congestive heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0878544
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0018802
resting ejection fraction < 50% or fractional shortening < 25%
Descrição

ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0489482
uncorrected primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathy, or significant systemic ventricular outflow obstruction
Descrição

valvular disease; Ventricular Outflow Obstruction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018824
UMLS CUI [2]
C0042512
low resting systolic blood pressure: < 90 mm hemoglobin (hg)
Descrição

systolic blood pressure; hemoglobin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0019046
bradycardia: heart rate < 50 beats per minute (bpm)
Descrição

bradycardia; heart rate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428977
UMLS CUI [2]
C0018810
sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or implantable device; significant conduction defects (i.e.: second or third degree atrio-ventricular block or sick sinus syndrome)
Descrição

ventricular dysrhythmias; sick sinus syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085612
UMLS CUI [2]
C0037052
history or current clinical evidence of moderate -to-severe obstructive pulmonary disease or reactive airway diseases (i.e.: asthma) requiring therapy
Descrição

obstructive pulmonary disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0600260
significant hepatic (serum aspartate aminotransferase [ast] and/or alanine aminotransferase [alt] > 3 time upper limit of normal institutional normal), gastrointestinal, or biliary disorders that could impair absorption, metabolism, or excretion of orally administered medications
Descrição

Aspartate aminotransferase/Alanine aminotransferase; Gastrointestinal dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0364051
UMLS CUI [2]
C0679407
endocrine disorders such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism not controlled with medication, or insulin dependent diabetes mellitus
Descrição

endocrine disorders; primary aldosteronism

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0014130
UMLS CUI [2]
C1384514
females of child bearing potential who are pregnant, lactating, or sexually active and not taking adequate contraceptive precautions (i.e.: intrauterine device [iud] or oral contraceptives for 3 months prior to entry into the study)
Descrição

Contraception status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0420837
history of drug sensitivity or allergic reaction to alpha- or beta-blockers
Descrição

hypersensitivity beta-blockers

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001645
anemia (hematocrit < 28%)
Descrição

anemia; hematocrit

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0018935
use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of randomization
Descrição

investigational drug beta adrenergic blockers

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0001645
use of select cytochrome p450 2d6 (cyp2d6) inhibitor medications
Descrição

Cytochrome P-450 CYP2D6

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0057223
inability to swallow pills
Descrição

pills

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0994475
unwillingness or inability to cooperate, or, for the parents or guardians of minors, to give consent, or for the child to give assent, or any condition of sufficient severity to impair cooperation with the study
Descrição

compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
use of any other blood pressure lowering medication for treatment of hypertension, within 30 days of randomization
Descrição

medication blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0005823
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Similar models

Eligibility Cancer Survivor NCT01347970

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
diagnosis cancer; age
Item
cancer diagnosis prior to 22 years of age, irrespective of current age
boolean
C0011900 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
dose anthracycline; dexrazoxane
Item
lifetime cumulative anthracycline dose: >= 300 mg/m^2 without the protection of dexrazoxane (zinecard) therapy
boolean
C3174092 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C0086444 (UMLS CUI [2])
cancer treatment
Item
time from completion of cancer treatment to study entry: >= 2 years
boolean
C0920425 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
treatment cardiomyopathy; treatment congestive heart failure
Item
receiving treatment for cardiomyopathy or congestive heart failure
boolean
C0087111 (UMLS CUI [1,1])
C0878544 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0018802 (UMLS CUI [2,2])
ejection fraction
Item
resting ejection fraction < 50% or fractional shortening < 25%
boolean
C0489482 (UMLS CUI [1])
valvular disease; Ventricular Outflow Obstruction
Item
uncorrected primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathy, or significant systemic ventricular outflow obstruction
boolean
C0018824 (UMLS CUI [1])
C0042512 (UMLS CUI [2])
systolic blood pressure; hemoglobin
Item
low resting systolic blood pressure: < 90 mm hemoglobin (hg)
boolean
C0871470 (UMLS CUI [1])
C0019046 (UMLS CUI [2])
bradycardia; heart rate
Item
bradycardia: heart rate < 50 beats per minute (bpm)
boolean
C0428977 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
ventricular dysrhythmias; sick sinus syndrome
Item
sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or implantable device; significant conduction defects (i.e.: second or third degree atrio-ventricular block or sick sinus syndrome)
boolean
C0085612 (UMLS CUI [1])
C0037052 (UMLS CUI [2])
obstructive pulmonary disease
Item
history or current clinical evidence of moderate -to-severe obstructive pulmonary disease or reactive airway diseases (i.e.: asthma) requiring therapy
boolean
C0600260 (UMLS CUI [1])
Aspartate aminotransferase/Alanine aminotransferase; Gastrointestinal dysfunction
Item
significant hepatic (serum aspartate aminotransferase [ast] and/or alanine aminotransferase [alt] > 3 time upper limit of normal institutional normal), gastrointestinal, or biliary disorders that could impair absorption, metabolism, or excretion of orally administered medications
boolean
C0364051 (UMLS CUI [1])
C0679407 (UMLS CUI [2])
endocrine disorders; primary aldosteronism
Item
endocrine disorders such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism not controlled with medication, or insulin dependent diabetes mellitus
boolean
C0014130 (UMLS CUI [1])
C1384514 (UMLS CUI [2])
Contraception status
Item
females of child bearing potential who are pregnant, lactating, or sexually active and not taking adequate contraceptive precautions (i.e.: intrauterine device [iud] or oral contraceptives for 3 months prior to entry into the study)
boolean
C0420837 (UMLS CUI [1])
hypersensitivity beta-blockers
Item
history of drug sensitivity or allergic reaction to alpha- or beta-blockers
boolean
C0020517 (UMLS CUI [1,1])
C0001645 (UMLS CUI [1,2])
anemia; hematocrit
Item
anemia (hematocrit < 28%)
boolean
C0002871 (UMLS CUI [1])
C0018935 (UMLS CUI [2])
investigational drug beta adrenergic blockers
Item
use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of randomization
boolean
C0013230 (UMLS CUI [1,1])
C0001645 (UMLS CUI [1,2])
Cytochrome P-450 CYP2D6
Item
use of select cytochrome p450 2d6 (cyp2d6) inhibitor medications
boolean
C0057223 (UMLS CUI [1])
pills
Item
inability to swallow pills
boolean
C0994475 (UMLS CUI [1])
compliance
Item
unwillingness or inability to cooperate, or, for the parents or guardians of minors, to give consent, or for the child to give assent, or any condition of sufficient severity to impair cooperation with the study
boolean
C1321605 (UMLS CUI [1])
medication blood pressure
Item
use of any other blood pressure lowering medication for treatment of hypertension, within 30 days of randomization
boolean
C0013227 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
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