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])
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])