Clinical Trial: Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension

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

Official Title: Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension

Brief Summary:

"Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe form of pulmonary hypertension characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary hypertension, and right failure.

In patients deemed operable, pulmonary endarterectomy (PEA) is the gold standard treatment and is the only potentially curative treatment. However, some patients are ineligible for surgery owing to occlusion of distal vessels. The best treatment option for these non-operable CTEPH patients is not yet established.


Detailed Summary: Currently, riociguat is the only drug approved in Europe and US for the treatment of non-operable CTEPH. However, medical therapy with riociguat does not address obstructive lesions. In this sense, another treatment option, balloon pulmonary angioplasty (BPA), began recently to gain widespread interest after development in several centers. This procedure uses the standard balloon angioplasty technique to dilate selected pulmonary arteries. The main aim is to reopen vessels occluded by webs and bands. Several teams, mainly from Japan, have reported their experiences with BPA for the treatment of non-operable CTEPH and demonstrated impressive decrease in pulmonary vascular resistance and improvement in functional status and exercise capacity with an acceptable procedure-related risk. Although BPA has never been prospectively evaluated, most of the leading CTEPH centers worldwide have currently added BPA to their therapeutic options. However, no randomized controlled trial comparing safety and efficacy of medical therapy with riociguat versus pulmonary balloon angioplasty has been performed so far. Therefore, the respective places of medical treatment and of BPA in the management of inoperable patients with CTEPH need to be further evaluated.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Change from baseline in Pulmonary Vascular Resistance (PVR) [ Time Frame: Baseline and at 26 weeks ]

Original Primary Outcome: Change from baseline in Pulmonary Vascular Resistance (PVR) [ Time Frame: 26 weeks after the treatment ]

Current Secondary Outcome:

  • Change from Baseline in 6 Minute Walking Distance (6MWD) [ Time Frame: Baseline and at 26 weeks ]
  • Change from Baseline in WHO functional class (FC) [ Time Frame: Baseline and at 26 weeks ]
  • Change from Baseline in brain natriuretic peptide (BNP) [ Time Frame: Baseline and at 26 weeks ]
  • Change from Baseline in Borg dyspnea score (measured at the end of the 6MWD Test [ Time Frame: Baseline and at 26 weeks ]
  • Time To Clinical Worsening defined by the occurence of - Death (all-cause mortality or Lung - or Heart-lung transplantation - or Hospitalization due to persistent worsening of PH or - Start of PAH specific treatment [ Time Frame: Up to 26 weeks ]


Original Secondary Outcome:

  • Change from Baseline in 6 Minute Walking Distance (6MWD) [ Time Frame: 26 weeks after the treatment ]
  • Change from Baseline in WHO functional class (FC) [ Time Frame: 26 weeks after the treatment ]
  • Change from Baseline in brain natriuretic peptide (BNP) [ Time Frame: 26 weeks after the treatment ]
  • Change from Baseline in Borg dyspnea score (measured at the end of the 6MWD Test [ Time Frame: 26 weeks after the treatment ]
  • Time To Clinical Worsening defined by the occurence of - Death (all-cause mortality or Lung - or Heart-lung transplantation - or Hospitalization due to persistent worsening of PH or - Start of PAH specific treatment [ Time Frame: Up to 26 weeks ]


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: December 8, 2015
Date Started: January 2016
Date Completion: September 2019
Last Updated: September 28, 2016
Last Verified: September 2016