Chronic Thromboembolic Pulmonary Hypertension Clinical Trial
Official title:
Randomized Pilot Trial of Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy
The study evaluates the technique of non-drug treatment of residual pulmonary hypertension in patients with chronic thromboembolic pulmonary hypertension after pulmonary thromboendarterectomy.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | February 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - presence of residual pulmonary hypertension in patients after pulmonary thromboendarterectomy according to right heart catheterization: mean pulmonary artery pressure > 25 mm Hg or pulmonary vascular resistance > 400 dyn x sec x cm-5 Exclusion Criteria: - no evidence of residual pulmonary hypertension in patients after pulmonary thromboendarterectomy (mean pulmonary artery pressure <25 m Hg). - refusal of a patient to participate in the study. - the presence of severe concomitant diseases of the cardiovascular system and lungs, leading to pulmonary hypertension - the presence of other severe comorbidities that may result in death within a year. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | Novosibirsk research institute of circulation pathology | Novosibirsk | Novosibirskaya oblast' |
Lead Sponsor | Collaborator |
---|---|
Novosibirsk Scientific Research Institute for Circulatory Pathology |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary vascular resistance | Units - (dyn x sec x cm-5) | 12 months | Yes |
Secondary | 6-minute walking distance test | 12 months | Yes | |
Secondary | Echocardiographical sings of right ventricle function - 1 | Fractional area change (%) | 12 months | Yes |
Secondary | Echocardiographical sings of right ventricle function - 2 | Tricuspid annular systolic excursion, TAPSE (mm) | 12 months | Yes |
Secondary | Pulmonary artery pressure | Pulmonary artery pressure (systolic/diastolic/mean) will be measured by right heart catheterization | 12 months | Yes |
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