ID

39386

Beskrivning

Evaluation of the Effects of Urotensin-II and Soluble Epoxide Hydrolase Inhibitors on Skin Microvessel Tone in Patients With Heart Failure, and in Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT00654966

Länk

https://clinicaltrials.gov/show/NCT00654966

Nyckelord

Versioner (1)
  1. 2020-01-06 2020-01-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 januari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00654966

Engelsk

Eligibility Heart Failure NCT00654966

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
male/female over 18 and under 80 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
females must be non-pregnant, non-lactating and using reliable means of contraception (surgical sterilisation or a barrier method such as a condom). the oral contraceptive pill is an exclusion to this study.
Beskrivning

Gender | Pregnancy Absent | Breast Feeding Absent | Contraceptive methods | Female Sterilization | Contraception, Barrier | Female Condoms | Oral Contraceptives Excluded

Datatyp

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]
C0700589
UMLS CUI [5]
C0015787
UMLS CUI [6]
C0004764
UMLS CUI [7]
C0221829
UMLS CUI [8,1]
C0009905
UMLS CUI [8,2]
C0332196
patients with chf will be required to have left ventricular fractional shortening [lvfs] of <22% or lvef < 40% and new york heart association functional class [nyha fc] ii-iii symptoms
Beskrivning

Congestive heart failure | Left Ventricular Fractional Shortening | Left ventricular ejection fraction | Symptoms New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C1335957
UMLS CUI [3]
C0428772
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C1275491
body mass index (bmi) between 18-35 kg/m2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
screening clinical laboratory tests including liver function tests and hba1c are within the normal reference range for the investigative site.
Beskrivning

Normal Laboratory Test Result | Liver function tests normal | Hemoglobin A1c level result Normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0438214
UMLS CUI [2]
C0438235
UMLS CUI [3,1]
C1261236
UMLS CUI [3,2]
C0205307
electrocardiogram (ecg) results considered within normal limits, as determined by the investigator.
Beskrivning

ECG normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0522054
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
smokers
Beskrivning

Tobacco use

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological, or other disorders capable of altering the absorption, metabolism, or elimination of drugs, or of constituting a risk factor when exposed to the study medication.
Beskrivning

Cardiovascular Diseases | Respiration Disorders | Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Nervous system disorder | Disease Affecting Drug absorption | Disease Affecting Drug metabolism | Disease Affecting Drug elimination | Disease Investigational New Drugs At risk

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0035204
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0027765
UMLS CUI [7,1]
C0012634
UMLS CUI [7,2]
C0392760
UMLS CUI [7,3]
C0678745
UMLS CUI [8,1]
C0012634
UMLS CUI [8,2]
C0392760
UMLS CUI [8,3]
C0683140
UMLS CUI [9,1]
C0012634
UMLS CUI [9,2]
C0392760
UMLS CUI [9,3]
C0683141
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0013230
UMLS CUI [10,3]
C1444641
those requiring concomitant medications that will affect cardiovascular or endothelial function or blood pressure control (eg cholesterol lowering medication, hormone replacement therapy, aspirin, nsaids).
Beskrivning

Pharmaceutical Preparations Affecting Cardiovascular function | Pharmaceutical Preparations Affecting Function Endothelial | Pharmaceutical Preparations Affecting Control of blood pressure | Anticholesteremic Agents | Hormone replacement therapy | Aspirin | Anti-Inflammatory Agents, Non-Steroidal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0007227
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0031843
UMLS CUI [2,4]
C0014257
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1753303
UMLS CUI [4]
C0003277
UMLS CUI [5]
C0282402
UMLS CUI [6]
C0004057
UMLS CUI [7]
C0003211
patients receiving hormone replacement therapy.
Beskrivning

Hormone replacement therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0282402
known allergy or hypersensitivity to urotensin or urotensin receptor antagonists or its excipients, or related drugs, or a history of relevant adverse drug reactions of any origin.
Beskrivning

Hypersensitivity Urotensin | Hypersensitivity Urotensin receptor antagonists | Hypersensitivity Urotensin Excipient | Hypersensitivity Pharmaceutical Preparations Related | Adverse reaction to drug

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0077932
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1540171
UMLS CUI [2,3]
C0243076
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0077932
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0439849
UMLS CUI [5]
C0041755
regular alcohol intake greater than 14 units/week or is unwilling to comply with the alcohol prohibition for the duration of the study (1 unit of alcohol is equivalent to: 12 ounces of beer, 4 ounces of wine, or 1 ounce of 50-proof hard liquor).
Beskrivning

Alcohol consumption units per week | Alcohol Abstinence Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
UMLS CUI [2,1]
C0678274
UMLS CUI [2,2]
C0558080
history of drug abuse.
Beskrivning

Drug abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0013146
screening biochemistry > 20 % outside normal limits.
Beskrivning

Abnormal biochemistry finding

Datatyp

boolean

Alias
UMLS CUI [1]
C0586680
patients who are thought to be terminally ill or immuno-compromised
Beskrivning

Terminal illness | Immunocompromised patient

Datatyp

boolean

Alias
UMLS CUI [1]
C0679247
UMLS CUI [2]
C0085393
patients who have previously been enrolled in this study or have received other experimental medications in the last 4 weeks.
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
patients who are unlikely to comply with study procedures
Beskrivning

Protocol Compliance Unlikely

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
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Similar models

Eligibility Heart Failure NCT00654966

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
confirmed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
male/female over 18 and under 80 years of age.
boolean
C0001779 (UMLS CUI [1])
Gender | Pregnancy Absent | Breast Feeding Absent | Contraceptive methods | Female Sterilization | Contraception, Barrier | Female Condoms | Oral Contraceptives Excluded
Item
females must be non-pregnant, non-lactating and using reliable means of contraception (surgical sterilisation or a barrier method such as a condom). the oral contraceptive pill is an exclusion to this study.
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])
C0700589 (UMLS CUI [4])
C0015787 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0221829 (UMLS CUI [7])
C0009905 (UMLS CUI [8,1])
C0332196 (UMLS CUI [8,2])
Congestive heart failure | Left Ventricular Fractional Shortening | Left ventricular ejection fraction | Symptoms New York Heart Association Classification
Item
patients with chf will be required to have left ventricular fractional shortening [lvfs] of <22% or lvef < 40% and new york heart association functional class [nyha fc] ii-iii symptoms
boolean
C0018802 (UMLS CUI [1])
C1335957 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
C1457887 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) between 18-35 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Normal Laboratory Test Result | Liver function tests normal | Hemoglobin A1c level result Normal
Item
screening clinical laboratory tests including liver function tests and hba1c are within the normal reference range for the investigative site.
boolean
C0438214 (UMLS CUI [1])
C0438235 (UMLS CUI [2])
C1261236 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
ECG normal
Item
electrocardiogram (ecg) results considered within normal limits, as determined by the investigator.
boolean
C0522054 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tobacco use
Item
smokers
boolean
C0543414 (UMLS CUI [1])
Cardiovascular Diseases | Respiration Disorders | Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Nervous system disorder | Disease Affecting Drug absorption | Disease Affecting Drug metabolism | Disease Affecting Drug elimination | Disease Investigational New Drugs At risk
Item
history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological, or other disorders capable of altering the absorption, metabolism, or elimination of drugs, or of constituting a risk factor when exposed to the study medication.
boolean
C0007222 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C0012634 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C0678745 (UMLS CUI [7,3])
C0012634 (UMLS CUI [8,1])
C0392760 (UMLS CUI [8,2])
C0683140 (UMLS CUI [8,3])
C0012634 (UMLS CUI [9,1])
C0392760 (UMLS CUI [9,2])
C0683141 (UMLS CUI [9,3])
C0012634 (UMLS CUI [10,1])
C0013230 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
Pharmaceutical Preparations Affecting Cardiovascular function | Pharmaceutical Preparations Affecting Function Endothelial | Pharmaceutical Preparations Affecting Control of blood pressure | Anticholesteremic Agents | Hormone replacement therapy | Aspirin | Anti-Inflammatory Agents, Non-Steroidal
Item
those requiring concomitant medications that will affect cardiovascular or endothelial function or blood pressure control (eg cholesterol lowering medication, hormone replacement therapy, aspirin, nsaids).
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0007227 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0031843 (UMLS CUI [2,3])
C0014257 (UMLS CUI [2,4])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1753303 (UMLS CUI [3,3])
C0003277 (UMLS CUI [4])
C0282402 (UMLS CUI [5])
C0004057 (UMLS CUI [6])
C0003211 (UMLS CUI [7])
Hormone replacement therapy
Item
patients receiving hormone replacement therapy.
boolean
C0282402 (UMLS CUI [1])
Hypersensitivity Urotensin | Hypersensitivity Urotensin receptor antagonists | Hypersensitivity Urotensin Excipient | Hypersensitivity Pharmaceutical Preparations Related | Adverse reaction to drug
Item
known allergy or hypersensitivity to urotensin or urotensin receptor antagonists or its excipients, or related drugs, or a history of relevant adverse drug reactions of any origin.
boolean
C0020517 (UMLS CUI [1,1])
C0077932 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1540171 (UMLS CUI [2,2])
C0243076 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0077932 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C0041755 (UMLS CUI [5])
Alcohol consumption units per week | Alcohol Abstinence Unwilling
Item
regular alcohol intake greater than 14 units/week or is unwilling to comply with the alcohol prohibition for the duration of the study (1 unit of alcohol is equivalent to: 12 ounces of beer, 4 ounces of wine, or 1 ounce of 50-proof hard liquor).
boolean
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
C0678274 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Drug abuse
Item
history of drug abuse.
boolean
C0013146 (UMLS CUI [1])
Abnormal biochemistry finding
Item
screening biochemistry > 20 % outside normal limits.
boolean
C0586680 (UMLS CUI [1])
Terminal illness | Immunocompromised patient
Item
patients who are thought to be terminally ill or immuno-compromised
boolean
C0679247 (UMLS CUI [1])
C0085393 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
patients who have previously been enrolled in this study or have received other experimental medications in the last 4 weeks.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Protocol Compliance Unlikely
Item
patients who are unlikely to comply with study procedures
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
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