Clinical Trial: Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Pilot Trial of Interventional Treatment of Residual Pulmonary Hypertension in Patients After Pulmonary Thromboendarterectomy

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 Summary: 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)
Sponsor: Novosibirsk Scientific Research Institute for Circulatory Pathology

Current Primary Outcome: Pulmonary vascular resistance [ Time Frame: 12 months ]

Units - (dyn x sec x cm-5)


Original Primary Outcome: Pulmonary artery pressure [ Time Frame: 12 months ]

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


Current Secondary Outcome:

  • 6-minute walking distance test [ Time Frame: 12 months ]
  • Echocardiographical sings of right ventricle function - 1 [ Time Frame: 12 months ]
    Fractional area change (%)
  • Echocardiographical sings of right ventricle function - 2 [ Time Frame: 12 months ]
    Tricuspid annular systolic excursion, TAPSE (mm)
  • Pulmonary artery pressure [ Time Frame: 12 months ]
    Pulmonary artery pressure (systolic/diastolic/mean) will be measured by right heart catheterization


Original Secondary Outcome:

  • 6-minute walking distance test [ Time Frame: 12 months ]
  • Echocardiographical sings of right ventricle function: look Description part. [ Time Frame: 12 months ]
    Fractional area change (%)
  • Echocardiographical sings of right ventricle function: look Description part. [ Time Frame: 12 months ]
    Tricuspid annular systolic excursion, TAPSE (mm)
  • Pulmonary vascular resistance [ Time Frame: 12 months ]
    Units - (dyn x sec x cm-5)


Information By: Novosibirsk Scientific Research Institute for Circulatory Pathology

Dates:
Date Received: April 4, 2016
Date Started: August 2015
Date Completion: February 2017
Last Updated: June 1, 2016
Last Verified: June 2016