Clinical trial NCT02745106: Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy
Official title: Randomized Pilot Trial of Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Keywords: Chronic thromboembolic pulmonary hypertension, Navigation system, Ablation
Lead sponsor: Novosibirsk Scientific Research Institute for Circulatory Pathology
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary vascular resistance
timeFrame: 12 months
Secondary outcomes:
measure: 6-minute walking distance test
timeFrame: 12 months
measure: Echocardiographical sings of right ventricle function - 1
timeFrame: 12 months
measure: Echocardiographical sings of right ventricle function - 2
timeFrame: 12 months
measure: Pulmonary artery pressure
timeFrame: 12 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk research institute of circulation pathology
state: Novosibirskaya oblast'
Study officials:
affiliation: 15 Rechkunovskaya street, Novosibirsk, Russia, 630055
name: Alexander Chernyavskiy, PhD
role: STUDY_CHAIR
affiliation: Novosibirsk Scientific Research Institute for Circulatory Pathology
name: Alexander Romanov, PhD
role: STUDY_CHAIR
affiliation: Novosibirsk Scientific Research Institute for Circulatory Pathology
name: Evgeny Pokushalov, PhD
role: STUDY_CHAIR
References: