ID

39392

Beschreibung

A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF); ODM derived from: https://clinicaltrials.gov/show/NCT01064037

Link

https://clinicaltrials.gov/show/NCT01064037

Stichworte

Versionen (1)
  1. 07.01.20 07.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Januar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01064037

Englisch

Eligibility Heart Failure NCT01064037

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovarectomy, and women with a hysterectomy
Beschreibung

Gender | Pregnancy Absent | Breast Feeding Absent | Age | Childbearing Potential Absent | Postmenopausal state | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0001779
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0332197
UMLS CUI [6]
C0232970
UMLS CUI [7]
C0589114
UMLS CUI [8]
C0278321
UMLS CUI [9]
C0020699
subjects must have the clinical diagnosis of congestive heart failure (chf) made at least three months prior to enrollment
Beschreibung

Congestive heart failure Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0872146
subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: dyspnea and clinical evidence of volume overload
Beschreibung

Symptoms Worsening | Hospitalization | Dyspnea | Fluid overload

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332271
UMLS CUI [2]
C0019993
UMLS CUI [3]
C0013404
UMLS CUI [4]
C0546817
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute de-novo heart failure
Beschreibung

Heart failure de novo

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1515568
acute myocardial infarction and/or myocardial infarction within 30 days
Beschreibung

Myocardial Infarction | Recent myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1998297
valvular heart disease requiring surgical intervention during the course of the study
Beschreibung

Heart valve disease Requirement Surgical intervention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0549433
heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
Beschreibung

Heart failure Due to Valvular disease | Heart failure Associated with Valvular disease | Heart Valve Prosthesis malfunction | Congenital heart disease uncorrected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3258293
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C3258293
UMLS CUI [3,1]
C0018825
UMLS CUI [3,2]
C1504465
UMLS CUI [4,1]
C0152021
UMLS CUI [4,2]
C4072785
primary hypertrophic cardiomyopathy
Beschreibung

Primary hypertrophic cardiomyopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C3665332
acute inflammatory heart disease, eg, acute myocarditis
Beschreibung

Heart Disease inflammatory | Myocarditis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0333348
UMLS CUI [2]
C0027059
unstable angina requiring angiography
Beschreibung

Unstable Angina Requirement Angiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0002978
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Ähnliche Modelle

Eligibility Heart Failure NCT01064037

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Pregnancy Absent | Breast Feeding Absent | Age | Childbearing Potential Absent | Postmenopausal state | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy
Item
male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovarectomy, and women with a hysterectomy
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0232970 (UMLS CUI [6])
C0589114 (UMLS CUI [7])
C0278321 (UMLS CUI [8])
C0020699 (UMLS CUI [9])
Congestive heart failure Disease length
Item
subjects must have the clinical diagnosis of congestive heart failure (chf) made at least three months prior to enrollment
boolean
C0018802 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Symptoms Worsening | Hospitalization | Dyspnea | Fluid overload
Item
subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: dyspnea and clinical evidence of volume overload
boolean
C1457887 (UMLS CUI [1,1])
C0332271 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2])
C0013404 (UMLS CUI [3])
C0546817 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Heart failure de novo
Item
acute de-novo heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
Myocardial Infarction | Recent myocardial infarction
Item
acute myocardial infarction and/or myocardial infarction within 30 days
boolean
C0027051 (UMLS CUI [1])
C1998297 (UMLS CUI [2])
Heart valve disease Requirement Surgical intervention
Item
valvular heart disease requiring surgical intervention during the course of the study
boolean
C0018824 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0549433 (UMLS CUI [1,3])
Heart failure Due to Valvular disease | Heart failure Associated with Valvular disease | Heart Valve Prosthesis malfunction | Congenital heart disease uncorrected
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 [1,1])
C0678226 (UMLS CUI [1,2])
C3258293 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C3258293 (UMLS CUI [2,3])
C0018825 (UMLS CUI [3,1])
C1504465 (UMLS CUI [3,2])
C0152021 (UMLS CUI [4,1])
C4072785 (UMLS CUI [4,2])
Primary hypertrophic cardiomyopathy
Item
primary hypertrophic cardiomyopathy
boolean
C3665332 (UMLS CUI [1])
Heart Disease inflammatory | Myocarditis
Item
acute inflammatory heart disease, eg, acute myocarditis
boolean
C0018799 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0027059 (UMLS CUI [2])
Unstable Angina Requirement Angiography
Item
unstable angina requiring angiography
boolean
C0002965 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0002978 (UMLS CUI [1,3])
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