Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Primary pulmonary hypertension and New York Health Association (NYHA) chronic heart failure (CHF) functional class II-III
Ability to walk \>= 50 meters on the 6 minute walk test
Resting mean pulmonary artery pressure \> 25 mmHg
Mean right atrial pressure \<= 20 mmHg
Pulmonary capillary wedge pressure \<= 15 mmHg
Cardiac index \> 2.5 L/min2
SvO2 sat. \> 63%
Male of female at least 18 years old
Signed written informed consent
You may not be if
Secondary pulmonary hypertension due to lung or systemic diseases
Pregnant of nursing women, or women of childbearing potential who are not using adequate methods of birth control
Concurrent systematic use of aspirin, aspirin like drugs, or non-steroidal anti-inflammatory drugs (NSAIDs)
Surgery of bleeding from gastrointestinal, genitourinary tract, cerebrum or retina within past 6 weeks
History of bleeding diathesis or a platelet count less than 70,000/mm3
Exercise limited by factors other than fatigue or exertional dyspnea, such as arthritis, claudication, angina, chronic obstructive pulmonary disease, or bronchial asthma
Myocardial infarction, stroke, or transient ischemic attack within the preceding six months
Systolic blood pressure \< 90 mmHg or \> 180 mmHg, or diastolic blood pressure \> 110 mmHg
Known drug or alcohol dependency within one year of entry into the study
Known hypersensitivity to any component of the study formulation, epoprostenol, nitric oxide, or adenosine
Psychiatric or other illness or condition which, in the opinion of the principal investigator, may interfere with study participation, compliance, or other elements of the protocol
Participation in an evaluation of an investigational drug within the past 30 days
Portal hypertension or cirrhosis of the liver
Congenital heart disease e.g., atrial septal defect; patent foramen ovale does not exclude patient from the study
Appetite suppressants such as fenfluramine, dexfenfluramine, and inhibitors of serotonin uptake known to be associated with primary pulmonary hypertension, received within 3 months of entry into the study
HIV positive
Vasodilators. Patients will not receive Ca-channel blockers during the study unless the medication was started prior to the study and the patient has been on a stable dose for at least one month prior to entry
Clareo Health | Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension
