Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension (RACE)
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|ClinicalTrials.gov Identifier: NCT02634203|
Recruitment Status : Unknown
Verified November 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : December 17, 2015
Last Update Posted : November 20, 2017
"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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
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 ]
- 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 ]
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
|Contact: Xavier JAIS, MD, PhDIfirstname.lastname@example.org|
|Contact: Gérald SIMONNEAU, MD, PhDIemail@example.com|
|Principal Investigator:||Xavier JAIS, MD, PhDI||AP-HP, Bicêtre Hospital|