Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension (RACE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02634203|
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : January 26, 2021
"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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Thromboembolic Pulmonary Hypertension||Procedure: Balloon Pulmonary Angioplasty (BPA) Drug: Riociguat||Not Applicable|
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.
An ancillary study will evaluate the efficacy and safety of employment of two sequentially used treatments at 12 months. The studied population is that of the study RACE. The patient follow-up period will be extended by 6 months, its duration of participation will be in total of 13 months. The exams will be the same as those of the V3 of the RACE study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension|
|Actual Study Start Date :||January 19, 2016|
|Actual Primary Completion Date :||January 27, 2020|
|Actual Study Completion Date :||January 27, 2020|
Experimental: Balloon Pulmonary Angioplasty (BPA)
Non-operable patients with CTEPH allocated to BPA arm
Procedure: Balloon Pulmonary Angioplasty (BPA)
Balloon pulmonary angioplasty (BPA) will be done via femoral vein. 2 sessions will be performed during the same hospitalization following by additional sessions at an interval of 2-3 weeks until a mean PAP< 30 mmHg is achieved A pulmonary angiography and a right heart catheterization will be performed at each BPA session
Active Comparator: Riociguat
Non-operable patients with CTEPH allocated to Riociguat arm
The starting dose will be 1 mg three times daily as recommended. The dose will be titrated every 2 weeks according to the peripheral systolic pressure. Dose should be increased by 0.5 mg three times daily every two weeks to a maximum of 2.5 mg three times daily, if systolic blood pressure is ≥95 mmHg and the patient has no signs or symptoms of hypotension.
Other Name: Medical therapy with Riociguat
- Change from baseline in Pulmonary Vascular Resistance (PVR) [ Time Frame: Baseline and at 26 weeks ]Pulmonary Vascular Resistance (PVR)
- Change from Baseline in 6 Minute Walking Distance (6MWD) [ Time Frame: Baseline and at 26 weeks ]6 Minute Walking Distance (6MWD)
- Change from Baseline in WHO (World Health Organization) functional class (FC) [ Time Frame: Baseline and at 26 weeks ]WHO functional class (FC)
- Change from baseline in NT PRO-BNP [ Time Frame: Baseline and at 26 weeks ]NT PRO-BNP (N Terminale Pro-Brain Natriuretic Peptide ) results
- Change from Baseline in Borg dyspnea score (measured at the end of the 6MWD Test [ Time Frame: Baseline and at 26 weeks ]Borg dyspnea score (measured at the end of the 6MWD Test)
- 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 ]Clinical Worsening
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634203
|AP-HP, Bicêtre Hospital|
|Le Kremlin Bicetre, France, 94275|
|Principal Investigator:||Xavier JAIS, MD, PhDI||AP-HP, Bicêtre Hospital|