ID

13698

Beschreibung

Alprostadil Continuous Intravenous Infusion in Bridging Cardiac Transplant in Severe Heart Failure Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00610051

Link

https://clinicaltrials.gov/show/NCT00610051

Stichworte

Versionen (1)
  1. 28.02.16 28.02.16 -
Hochgeladen am

28. Februar 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00610051

Englisch

Eligibility Heart Failure NCT00610051

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients of either gender and of any race/ethnicity who are between 18 and 70 years of age inclusive
Beschreibung

ethnic group; gender; Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0015031
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
2. patients in advanced cardiac heart failure in new york heart association (nyha) functional class iiib or iv
Beschreibung

cardiac heart failure; nyha classification

Datentyp

boolean

Alias
UMLS CUI [1]
C2882277
UMLS CUI [2]
C1275491
3. eligible for heart transplant according to the ishlt guidelines ; it is not necessary that the patient already be listed at time of screening
Beschreibung

heart transplant

Datentyp

boolean

Alias
UMLS CUI [1]
C0018823
4. patients with secondary pulmonary hypertension (pulmonary artery pressure [pap] > 50 mmhg on echocardiography or pulmonary resistance on right heart catheterization), who are usually excluded from transplantation under conventional conditions, are eligible for inclusion in this study
Beschreibung

secondary pulmonary hypertension; echocardiography; pulmonary resistance

Datentyp

boolean

Alias
UMLS CUI [1]
C0020542
UMLS CUI [2]
C0013516
UMLS CUI [3]
C0456261
5. patients with left ventricular ejection fraction (lvef) ≤ 35% by any acceptable method (e.g., echocardiography, radionuclideventriculography, or ventriculography) assessed within the 3 months prior to randomization
Beschreibung

left ventricular ejection fraction; Cardiac ventriculography

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0596683
6. nt-probnp > 2000 pg/ml
Beschreibung

nt-probnp

Datentyp

boolean

Alias
UMLS CUI [1]
C1963813
7. women of childbearing potential (i.e., who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must commit either to abstain continuously from heterosexual sexual contact or to use at least one "highly effective" method of birth control (e.g., intrauterine device [iud], hormonal contraception, tubal ligation, or partner's vasectomy) or two "effective" methods (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to screening and throughout study participation
Beschreibung

Contraception status; Fertility Female

Datentyp

boolean

Alias
UMLS CUI [1]
C0420837
UMLS CUI [2]
C0015895
8. patients must be willing and able to give written informed consent. where required, a hipaa and/or state privacy consent must also be signed
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients urgently requiring transplantation (in the united states, united network for organ sharing [unos] status 1a; in the e.u., urgent request mode at eurotransplant)
Beschreibung

Organ Transplantation urgent; United Network for Organ Sharing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0439609
UMLS CUI [2]
C3826868
2. patients or their relatives/caregivers who are determined by the training nurse not to be capable of correctly using the pump delivery system and handling the study drug
Beschreibung

compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
3. patients presenting with unstable angina, aortic stenosis, pulmonary edema, severe chronic obstructive pulmonary disease, or acute gastric or duodenal ulcers
Beschreibung

comorbidity; unstable angina

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0002965
4. patients with a history of myocardial infarction or stroke within 6 months of screening
Beschreibung

medical history; myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0027051
5. patients with systolic blood pressure < 90 mmhg under euvolemic or hypervolemic conditions
Beschreibung

systolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
6. patients with significant chronic renal dysfunction (serum creatinine ≥2.5 mg/dl)
Beschreibung

chronic renal dysfunction; serum creatinine

Datentyp

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
7. female patients who are pregnant or nursing
Beschreibung

pregnancy; lactating

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. patients who have any concomitant illness or other finding that, in the opinion of the investigator, would confound the interpretation of the study results or place the patient at unacceptable risk if the patient were to participate in the study
Beschreibung

Compliance behavior Limited Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
9. patients with a known hypersensitivity to study drug or any component of the formulation of study drug (denatured ethanol)
Beschreibung

hypersensitivity study drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0008972
10. patients with prior participation in a study of alprostadil
Beschreibung

Study Subject Participation Status; alprostadil

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0002335
11. patients participating in another research study within 30 days prior to screening (i.e., the day the informed consent is signed) or anticipated to enroll in such during the 24 weeks after screening
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
12. patients for whom informed consent cannot be obtained
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
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Ähnliche Modelle

Eligibility Heart Failure NCT00610051

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
ethnic group; gender; Age
Item
1. patients of either gender and of any race/ethnicity who are between 18 and 70 years of age inclusive
boolean
C0015031 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
cardiac heart failure; nyha classification
Item
2. patients in advanced cardiac heart failure in new york heart association (nyha) functional class iiib or iv
boolean
C2882277 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
heart transplant
Item
3. eligible for heart transplant according to the ishlt guidelines ; it is not necessary that the patient already be listed at time of screening
boolean
C0018823 (UMLS CUI [1])
secondary pulmonary hypertension; echocardiography; pulmonary resistance
Item
4. patients with secondary pulmonary hypertension (pulmonary artery pressure [pap] > 50 mmhg on echocardiography or pulmonary resistance on right heart catheterization), who are usually excluded from transplantation under conventional conditions, are eligible for inclusion in this study
boolean
C0020542 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0456261 (UMLS CUI [3])
left ventricular ejection fraction; Cardiac ventriculography
Item
5. patients with left ventricular ejection fraction (lvef) ≤ 35% by any acceptable method (e.g., echocardiography, radionuclideventriculography, or ventriculography) assessed within the 3 months prior to randomization
boolean
C0428772 (UMLS CUI [1])
C0596683 (UMLS CUI [2])
nt-probnp
Item
6. nt-probnp > 2000 pg/ml
boolean
C1963813 (UMLS CUI [1])
Contraception status; Fertility Female
Item
7. women of childbearing potential (i.e., who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must commit either to abstain continuously from heterosexual sexual contact or to use at least one "highly effective" method of birth control (e.g., intrauterine device [iud], hormonal contraception, tubal ligation, or partner's vasectomy) or two "effective" methods (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to screening and throughout study participation
boolean
C0420837 (UMLS CUI [1])
C0015895 (UMLS CUI [2])
informed consent
Item
8. patients must be willing and able to give written informed consent. where required, a hipaa and/or state privacy consent must also be signed
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Organ Transplantation urgent; United Network for Organ Sharing
Item
1. patients urgently requiring transplantation (in the united states, united network for organ sharing [unos] status 1a; in the e.u., urgent request mode at eurotransplant)
boolean
C0029216 (UMLS CUI [1,1])
C0439609 (UMLS CUI [1,2])
C3826868 (UMLS CUI [2])
compliance
Item
2. patients or their relatives/caregivers who are determined by the training nurse not to be capable of correctly using the pump delivery system and handling the study drug
boolean
C1321605 (UMLS CUI [1])
comorbidity; unstable angina
Item
3. patients presenting with unstable angina, aortic stenosis, pulmonary edema, severe chronic obstructive pulmonary disease, or acute gastric or duodenal ulcers
boolean
C0009488 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
medical history; myocardial infarction
Item
4. patients with a history of myocardial infarction or stroke within 6 months of screening
boolean
C0262926 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
systolic blood pressure
Item
5. patients with systolic blood pressure < 90 mmhg under euvolemic or hypervolemic conditions
boolean
C0871470 (UMLS CUI [1])
chronic renal dysfunction; serum creatinine
Item
6. patients with significant chronic renal dysfunction (serum creatinine ≥2.5 mg/dl)
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
pregnancy; lactating
Item
7. female patients who are pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Compliance behavior Limited Comorbidity
Item
8. patients who have any concomitant illness or other finding that, in the opinion of the investigator, would confound the interpretation of the study results or place the patient at unacceptable risk if the patient were to participate in the study
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
hypersensitivity study drugs
Item
9. patients with a known hypersensitivity to study drug or any component of the formulation of study drug (denatured ethanol)
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Study Subject Participation Status; alprostadil
Item
10. patients with prior participation in a study of alprostadil
boolean
C2348568 (UMLS CUI [1])
C0002335 (UMLS CUI [2])
Study Subject Participation Status
Item
11. patients participating in another research study within 30 days prior to screening (i.e., the day the informed consent is signed) or anticipated to enroll in such during the 24 weeks after screening
boolean
C2348568 (UMLS CUI [1])
informed consent
Item
12. patients for whom informed consent cannot be obtained
boolean
C0021430 (UMLS CUI [1])
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