Clinical Trial: Balloon Pulmonary Angioplasty in Non-operable CTEPH Patients

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

Official Title: Assessment of Safety and Efficacy of Balloon Pulmonary Angioplasty in Non-operable CTEPH Patients

Brief Summary:

Balloon pulmonary angioplasty (BPA) emerged as a potential therapeutic option for non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH).

The aim of this study was to evaluate the safety and efficacy of BPA in patients disqualified from surgery or suffered from persistent CTEPH despite pulmonary endarterectomy.

This is a interventional study analyzing the benefits and the risk of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, haemodynamics, biomarkers, cardiopulmonary exercise test, echocardiography, electrocardiography and QoL assessment with Short Form 36 (SF36) questionnaire was performed before the initiation therapy of BPA, and 3-6 months after last session of BPA.


Detailed Summary:

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare but potentially life-threatening disease of the pulmonary circulation. Management of CTEPH requires precise differential diagnosis, long life anticoagulation when confirmed and qualification for surgical treatment by an experienced multidisciplinary team. The gold standard of treatment in operable patients is pulmonary endarterectomy (PEA), which is highly effective in restoring functional status and improving life expectancy. Nevertheless, even in the leading CTEPH referral centres almost 50% patients remain on medical treatment alone, with grim perspectives regarding life quality and expectancy. Recently, balloon pulmonary angioplasty (BPA) has emerged as a promising new interventional option in non-operable CTEPH.

The development BPA was far from rapid. It took 13 years from the first case-report to the publication of a first series of 17 patients treated with BPA in Boston/US and another 13 years until the results of first European series of 20 patients has been reported from Oslo/Norway. In Poland BPA was started to perform in non-operable CTEPH patients in 2013, motivated by their expected poor prognosis, when compared to those to whom surgical PEA was offered.

The aim of this study is an analysis of efficacy and safety of BPA procedure.

The BPA is performed by two senior interventional specialist - cardiologist and radiologist with extensive experience in coronary, pulmonary and general vessel interventions supported by perfusion nurse. All patients undergoing BPA are given informed consent before the first BPA intervention. The limited experience with and experimental nature of BPA are emphasised to candidates.

A standard BPA procedure is typically perfo
Sponsor: Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med

Current Primary Outcome:

  • Safety of BPA procedure. [ Time Frame: From initiation of BPA to 3-6 months after last session ]
    Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (<50ml), severe hemoptysis (>50ml), reperfusion pulmonary injury, death.
  • Improvement of haemodynamics caused by series of BPA. [ Time Frame: From initiation of BPA to 3-6 months after last session ]
    Measurements taken during right heart catheterization in at least 25 patients with accomplished interventional treatment of BPA. The measurements will include pulmonary artery pressure - PAP [mmHg].
  • Improvement of functional capacity caused by series of BPA. [ Time Frame: From initiation of BPA to 3-6 months after last session. ]
    Examined using World Health Organization (WHO) functional capacity classification is evaluated by physician in every patient, on admission and follow up.
  • Improvement of NT-proBNP caused by series of BPA. [ Time Frame: From initiation of BPA to 3-6 months after last session. ]
    Baseline measurements of the concentration of NT-proBNP [pg/ml] in at least 25 subjects who accomplished their invasive treatment.
  • Improvement of six minutes walk test caused by series of BPA. [ Time Frame: From initiation of BPA to 3-6 months after last session. ]
    Six minutes walking test - 6MWT is performed according to European Society of Cardiology (ESC) guidelines. The baseline distance [meters] covered during the 6MWT will be compar

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med

    Dates:
    Date Received: September 6, 2016
    Date Started: July 2013
    Date Completion: December 2018
    Last Updated: November 13, 2016
    Last Verified: November 2016