ID

12600

Beschrijving

A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF); ODM derived from: https://clinicaltrials.gov/show/NCT01067859

Link

https://clinicaltrials.gov/show/NCT01067859

Trefwoorden

  1. 04-12-15 04-12-15 -
Geüploaded op

4 december 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Acute Heart Failure NCT01067859

Eligibility Acute Heart Failure NCT01067859

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects, age >/= 18 years of age;
Beschrijving

non-pregnant, non-lactating women or women without childbearing potential

Datatype

boolean

Alias
UMLS CUI [1]
C0150831
UMLS CUI [2]
C0001779
Postmenopausal women aged 18 years or older.
Beschrijving

Postmenopausal women

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
Beschrijving

adequate contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
subjects must have the clinical diagnosis of congestive heart failure (chf) made at least three months prior to enrollment
Beschrijving

subjects must have the clinical diagnosis of congestive heart failure (chf) made at least three months prior to enrollment

Datatype

boolean

Alias
UMLS CUI [1]
C0018802
subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:
Beschrijving

subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study

Datatype

boolean

Alias
UMLS CUI [1]
C1821820
UMLS CUI [2]
C0019993
dyspnea
Beschrijving

dyspnea

Datatype

boolean

Alias
UMLS CUI [1]
C0013404
clinical evidence of volume overload
Beschrijving

clinical evidence of volume overload

Datatype

boolean

Alias
UMLS CUI [1]
C2236137
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Pregnancy or breastfeeding
Beschrijving

Pregnancy or breastfeeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
acute de-novo heart failure
Beschrijving

acute new heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0742752
acute myocardial infarction and/or myocardial infarction within 30 days
Beschrijving

acute myocardial infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0155626
valvular heart disease requiring surgical intervention during the course of the study
Beschrijving

valvular heart disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018824
heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
Beschrijving

heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0018824
UMLS CUI [3]
C0152021
primary hypertrophic cardiomyopathy
Beschrijving

primary hypertrophic cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0264847
acute inflammatory heart disease, eg, acute myocarditis
Beschrijving

acute inflammatory heart disease, eg, acute myocarditis

Datatype

boolean

Alias
UMLS CUI [1]
C0155686
UMLS CUI [2]
C0031046
UMLS CUI [3]
C0014118
unstable angina requiring angiography
Beschrijving

unstable angina

Datatype

boolean

Alias
UMLS CUI [1]
C0002965

Similar models

Eligibility Acute Heart Failure NCT01067859

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Patient age and sex
Item
male and female subjects, age >/= 18 years of age;
boolean
C0150831 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Postmenopausal women
Item
Postmenopausal women aged 18 years or older.
boolean
C0232970 (UMLS CUI [1])
adequate contraceptive methods
Item
women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
boolean
C0700589 (UMLS CUI [1])
subjects must have the clinical diagnosis of congestive heart failure (chf) made at least three months prior to enrollment
Item
subjects must have the clinical diagnosis of congestive heart failure (chf) made at least three months prior to enrollment
boolean
C0018802 (UMLS CUI [1])
subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study
Item
subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:
boolean
C1821820 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
dyspnea
Item
dyspnea
boolean
C0013404 (UMLS CUI [1])
clinical evidence of volume overload
Item
clinical evidence of volume overload
boolean
C2236137 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy or breastfeeding
Item
Pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
acute new heart failure
Item
acute de-novo heart failure
boolean
C0742752 (UMLS CUI [1])
acute myocardial infarction
Item
acute myocardial infarction and/or myocardial infarction within 30 days
boolean
C0155626 (UMLS CUI [1])
valvular heart disease
Item
valvular heart disease requiring surgical intervention during the course of the study
boolean
C0018824 (UMLS CUI [1])
heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
Item
heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
boolean
C0018801 (UMLS CUI [1])
C0018824 (UMLS CUI [2])
C0152021 (UMLS CUI [3])
primary hypertrophic cardiomyopathy
Item
primary hypertrophic cardiomyopathy
boolean
C0264847 (UMLS CUI [1])
acute inflammatory heart disease, eg, acute myocarditis
Item
acute inflammatory heart disease, eg, acute myocarditis
boolean
C0155686 (UMLS CUI [1])
C0031046 (UMLS CUI [2])
C0014118 (UMLS CUI [3])
unstable angina
Item
unstable angina requiring angiography
boolean
C0002965 (UMLS CUI [1])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial