Residual Pulmonary Hypertension Clinical Trial
Official title:
Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension
To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual pulmonary hypertension.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | October 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Patients with pulmonary embolism after undergone surgical treatment (intravascular thrombolysis, catheter thrombus fragmentation) - Patients with preserved thromboembolism in the pulmonary circulation system and mean pressure in the pulmonary artery of more than 25 mm Hg Exclusion Criteria: - Patient did not sign the informed consent. - Mean pulmonary artery pressure after surgical treatment less than 25 mm Hg - Age above 75 years. - Patients with an increased risk of bleeding - including gastric ulcer and 12 duodenal ulcer in acute, hemorrhagic stroke. - Severe coronary artery disease (unstable angina, myocardial infarction within the last 6 months). - Acute heart failure or CHF IV in NYHA. - Severe arrhythmias. - Pregnancy, lactation. - The presence of severe diseases of other organ systems that may result in death during the first year after surgery. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | State Research Institute of Circulation Pathology | Novosibirsk |
| Lead Sponsor | Collaborator |
|---|---|
| Meshalkin Research Institute of Pathology of Circulation |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pulmonary hypertension | The average pressure in the pulmonary artery trunk (according to direct tensiometry before Ventavis therapy, after the therapy according to transthoracic echocardiography and six months after discharge (transthoracic echocardiography). | 6 months | No |
| Secondary | Number of deaths | 6 months | Yes | |
| Secondary | Number of recurrent pulmonary embolisms | 6 months | No | |
| Secondary | Number of venous thromboembolisms | 6 months | No |