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Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

Phase 2
Conditions
Chronic Thromboembolic Pulmonary Hypertension
Registration Number
NCT02745106
Lead Sponsor
Novosibirsk Scientific Research Institute for Circulatory Pathology
Brief Summary

The study evaluates the technique of non-drug treatment of residual pulmonary hypertension in patients with chronic thromboembolic pulmonary hypertension after pulmonary thromboendarterectomy.

Detailed Description

The best strategy of treatment patients with chronic thromboembolic pulmonary hypertension is pulmonary thromboendarterectomy. In 5-30% of cases after pulmonary thromboendarterectomy residual pulmonary hypertension is persisted. The technique of radiofrequency pulmonary artery denervation in patients with idiopathic pulmonary arterial hypertension (type I) is known and was assessed during clinical investigation. In this study radiofrequency pulmonary artery denervation technique may be applied in patients with residual pulmonary hypertension after pulmonary thromboendarterectomy (type IV)

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Pulmonary vascular resistance12 months

Units - (dyn x sec x cm-5)

Secondary Outcome Measures
NameTimeMethod
6-minute walking distance test12 months
Echocardiographical sings of right ventricle function - 112 months

Fractional area change (%)

Echocardiographical sings of right ventricle function - 212 months

Tricuspid annular systolic excursion, TAPSE (mm)

Pulmonary artery pressure12 months

Pulmonary artery pressure (systolic/diastolic/mean) will be measured by right heart catheterization

Trial Locations

Locations (1)

Novosibirsk research institute of circulation pathology

🇷🇺

Novosibirsk, Novosibirskaya oblast', Russian Federation

Novosibirsk research institute of circulation pathology
🇷🇺Novosibirsk, Novosibirskaya oblast', Russian Federation
Alexander Edemskiy, MD
Contact
+79139160665
aeskander@yandex.ru

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