Chronic Thromboembolic Pulmonary HypertensionRACENCT02634203
Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension
A study testing Balloon Pulmonary Angioplasty (BPA) and Riociguat in people with Chronic Thromboembolic Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Balloon Pulmonary Angioplasty (BPA) and Riociguat
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2016to 27 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years of age at Visit 1
- CTEPH patients considered as non-operable but eligible for balloon pulmonary angioplasty and riociguat by the multidisciplinary meeting, with pulmonary vascular resistance > 320 dyn.sec.cm-5 and mean PAP > 25 mmHg and PWP (Pulmonary capillary Wedge Pressure) ≤ 15 mmHg measured at least 3 months after start of full anticoagulation. If the patient is treated with new oral anticoagulants drugs, NOAC's, (rivaroxaban, apixaban, dabigatran), the treatment should be switched to Vitamin K antagonist (VKA).
- The diagnosis of CTEPH must have been established based on 2 of the 3 following methods before study entry: ventilation-perfusion scan, pulmonary angiography, spiral-CT scan.
- The diagnosis of inoperability must have been established based on spiral-CT scan and/or pulmonary angiography before study entry.
- Unspecific treatments which may also be used for the treatment of pulmonary hypertension (PH) such as oral anticoagulants, diuretics, digitalis, calcium channel blockers or oxygen supplementation are permitted. However treatment with anticoagulants must have been started at least 3 months before Visit 1.
- Specific PH treatments (bosentan, ambrisentan, macitentan, sildenafil, tadalafil, epoprostenol, treprostinil, iloprost) are not permitted at Visit 1.
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- Patients who fulfill criteria for a supplemental long-term oxygen therapy (PaO2 < 55 mmHg at rest) need to be supplied sufficiently before study entry. The amount of supplemental oxygen and the delivery method need to be stable for at least one month before Visit 1.
- Right-heart catheterization results for the definite diagnosis of PH must not be older than 6 weeks at Visit 1 (will be considered as baseline values), must have been measured after at least 3 months of full anticoagulation, and must have been measured in the participating center under standardized conditions.
- Women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovarectomy, and women with hysterectomy can be included in the study. Women with childbearing potential can be included in the study only if a serological pregnancy test is negative and a combination of condoms with a safe and highly effective contraception method is used.
- Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period.
- Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures.
Who cannot join
- Participation in another clinical trial during the preceding 3 months.
- Pregnant women, or breast feeding women, or women with childbearing potential not using a combination of condoms and a safe and highly effective contraception method (hormonal contraception with implants or oral contraceptives, intrauterine devices ).
- Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator.
- Patients with underlying medical disorders and anticipated life expectancy below 2 years (eg active cancer disease with localized and/or metastasized tumor mass).
- Patients with a history of severe allergic-like reaction to intravascular administration of iodinated contrast media (including diffuse edema or facial edema with dyspnea, diffuse erythema with hypotension, laryngeal edema with stridor and/or hypoxia, bronchospasm, anaphylactic shock with hypotension and tachycardia)
- Significant obstructive or restrictive lung disease (forced expiratory volume < 60% predicted and/or total lung capacity < 70% predicted).
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- Severe hepatic impairment (Child-Pugh C)
- Left heart failure with an ejection fraction less than 40%
- Severe proven or suspected coronary artery disease (symptomatic patients with Canadian Cardiovascular Society Angina Classification class 2-4, and/or requiring nitrates, and/or myocardial infarction within the last 3 months before Visit 1).
- Severe renal insufficiency (glomerular filtration rate ≤ 30mL/min eg calculated based on the Cockcroft formula).
- Patient not covered by social security service
- Non-inclusion criteria related to treatment by riociguat:
- Patients with significant interstitial lung disease on High-resolution computed tomography (HRCT)
- Patients with hypersensitivity to riociguat or any of the excipients.
- Treatment with :
- PDE-5 Inhibitors (eg Sildenafil or Tadalafil)
- NO donors (eg Nitrates)
- Strong multi pathway cytochrome P450 (CYP) and P-glycoprotein (P-gp) / breast cancer resistance protein (BCRP) inhibitors such as azole antimycotics (e.g. ketoconazole, itraconazole) or HIV protease inhibitors (e.g. ritonavir)
- Systolic blood pressure <95mmHg
- Patients with a history of life-threatening hemoptysis (>100 mL in 24 h) or who have previously undergone bronchial arterial embolization for hemoptysis
- Non-inclusion criteria related to BPA:
- Patients who could not remain in a supine position for at least 120 min for any reason.
- Very distal CTEPH disease without stenosis, webs, or slits on CT scan and CTEPH disease with predominant complete occlusions of segmental or sub- segmental arteries (defined by the multidisciplinary meeting)
Trial locations and contacts
1 site in 1 country.
About this study
"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.
Read the detailed description
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.
- Being tested
- Balloon Pulmonary Angioplasty (BPA), Riociguat
- Keywords
- Chronic Thromboembolic Pulmonary Hypertension, Balloon Pulmonary Angioplasty, Riociguat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Pulmonary Angioplasty (BPA)Procedure or surgery
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
RiociguatDrug
Also called Medical therapy with Riociguat
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.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Pulmonary Angioplasty (BPA) | Experimental | Non-operable patients with CTEPH allocated to BPA arm Receives: Procedure: Balloon Pulmonary Angioplasty (BPA) |
| Riociguat | Active comparator | Non-operable patients with CTEPH allocated to Riociguat arm Receives: Drug: Riociguat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Pulmonary Vascular Resistance (PVR)
Pulmonary Vascular Resistance (PVR)
Measured: Baseline and at 26 weeks
Secondary outcomes (5)
Change from Baseline in 6 Minute Walking Distance (6MWD)
6 Minute Walking Distance (6MWD)
Measured: Baseline and at 26 weeks
Change from Baseline in WHO (World Health Organization) functional class (FC)
WHO functional class (FC)
Measured: Baseline and at 26 weeks
Change from baseline in NT PRO-BNP
NT PRO-BNP (N Terminale Pro-Brain Natriuretic Peptide ) results
Measured: Baseline and at 26 weeks
Change from Baseline in Borg dyspnea score (measured at the end of the 6MWD Test
Borg dyspnea score (measured at the end of the 6MWD Test)
Measured: 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
Clinical Worsening
Measured: Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start19 Jan 2016
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Xavier JAIS, MD, PhDI, Principal investigator, AP-HP, Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634203
- Sponsor's protocol ID
- AOM14123
- Other IDs
- 2015-A00973-46
- Acronym
- RACE
- Status last verified
- Nov 2017
- First submitted
- 8 Dec 2015
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gerges C, Jevnikar M, Brenot P, Savale L, Beurnier A, Bouvaist H, Sitbon O, Fadel E, Boucly A, Chemla D, Simonneau G, Humbert M, Montani D, Jais X; RACE Investigators. Effect of Balloon Pulmonary Angioplasty and Riociguat on Right Ventricular Afterload and Function in CTEPH: Insights From the RACE Trial. Circ Cardiovasc Interv. 2025 Feb;18(2):e014785. doi: 10.1161/CIRCINTERVENTIONS.124.014785. Epub 2025 Feb 18.
PubMed 39965044Jais X, Brenot P, Bouvaist H, Jevnikar M, Canuet M, Chabanne C, Chaouat A, Cottin V, De Groote P, Favrolt N, Horeau-Langlard D, Magro P, Savale L, Prevot G, Renard S, Sitbon O, Parent F, Tresorier R, Tromeur C, Piedvache C, Grimaldi L, Fadel E, Montani D, Humbert M, Simonneau G. Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (RACE): a multicentre, phase 3, open-label, randomised controlled trial and ancillary follow-up study. Lancet Respir Med. 2022 Oct;10(10):961-971. doi: 10.1016/S2213-2600(22)00214-4. Epub 2022 Aug 1.
PubMed 35926542
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02634203
- Acronym / sponsor ID
- RACE / AOM14123
- Keywords
- Chronic Thromboembolic Pulmonary Hypertension, Balloon Pulmonary Angioplasty, Riociguat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon Pulmonary Angioplasty (BPA) | Experimental | Procedure: Balloon Pulmonary Angioplasty (BPA)Non-operable patients with CTEPH allocated to BPA arm |
| Riociguat | Active comparator | Drug: RiociguatNon-operable patients with CTEPH allocated to Riociguat arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 to 80 years of age at Visit 1
- CTEPH patients considered as non-operable but eligible for balloon pulmonary angioplasty and riociguat by the multidisciplinary meeting, with pulmonary vascular resistance > 320 dyn.sec.cm-5 and mean PAP > 25 mmHg and PWP (Pulmonary capillary Wedge Pressure) ≤ 15 mmHg measured at least 3 months after start of full anticoagulation. If the patient is treated with new oral anticoagulants drugs, NOAC's, (rivaroxaban, apixaban, dabigatran), the treatment should be switched to Vitamin K antagonist (VKA).
- The diagnosis of CTEPH must have been established based on 2 of the 3 following methods before study entry: ventilation-perfusion scan, pulmonary angiography, spiral-CT scan.
- The diagnosis of inoperability must have been established based on spiral-CT scan and/or pulmonary angiography before study entry.
- Unspecific treatments which may also be used for the treatment of pulmonary hypertension (PH) such as oral anticoagulants, diuretics, digitalis, calcium channel blockers or oxygen supplementation are permitted. However treatment with anticoagulants must have been started at least 3 months before Visit 1.
Key exclusion criteria (23 listed)
- Participation in another clinical trial during the preceding 3 months.
- Pregnant women, or breast feeding women, or women with childbearing potential not using a combination of condoms and a safe and highly effective contraception method (hormonal contraception with implants or oral contraceptives, intrauterine devices ).
- Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator.
- Patients with underlying medical disorders and anticipated life expectancy below 2 years (eg active cancer disease with localized and/or metastasized tumor mass).
- Patients with a history of severe allergic-like reaction to intravascular administration of iodinated contrast media (including diffuse edema or facial edema with dyspnea, diffuse erythema with hypotension, laryngeal edema with stridor and/or hypoxia, bronchospasm, anaphylactic shock with hypotension and tachycardia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Balloon Pulmonary Angioplasty (BPA) |
| RiociguatAlso: Medical therapy with RiociguatThe 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. | Drug | Riociguat |
Primary outcome
Change from baseline in Pulmonary Vascular Resistance (PVR)
Time frame: Baseline and at 26 weeks
Pulmonary Vascular Resistance (PVR)
5 secondary outcomes
Change from Baseline in 6 Minute Walking Distance (6MWD)
Time frame: Baseline and at 26 weeks
Change from Baseline in WHO (World Health Organization) functional class (FC)
Time frame: Baseline and at 26 weeks
Change from baseline in NT PRO-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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Derived from this study: PubMed 39965044Gerges C, Jevnikar M, Brenot P, Savale L, Beurnier A, Bouvaist H, Sitbon O, Fadel E, Boucly A, Chemla D, Simonneau G, Humbert M, Montani D, Jais X; RACE Investigators. Effect of Balloon Pulmonary Angioplasty and Riociguat on Right Ventricular Afterload and Function in CTEPH: Insights From the RACE Trial. Circ Cardiovasc Interv. 2025 Feb;18(2):e014785. doi: 10.1161/CIRCINTERVENTIONS.124.014785. Epub 2025 Feb 18.
- Derived from this study: PubMed 35926542Jais X, Brenot P, Bouvaist H, Jevnikar M, Canuet M, Chabanne C, Chaouat A, Cottin V, De Groote P, Favrolt N, Horeau-Langlard D, Magro P, Savale L, Prevot G, Renard S, Sitbon O, Parent F, Tresorier R, Tromeur C, Piedvache C, Grimaldi L, Fadel E, Montani D, Humbert M, Simonneau G. Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (RACE): a multicentre, phase 3, open-label, randomised controlled trial and ancillary follow-up study. Lancet Respir Med. 2022 Oct;10(10):961-971. doi: 10.1016/S2213-2600(22)00214-4. Epub 2022 Aug 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier JAIS, MD, PhDI principal investigator
AP-HP, Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Pulmonary Angioplasty (BPA) and Riociguat in people with Chronic Thromboembolic Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Pulmonary Vascular Resistance (PVR) (time frame: Baseline and at 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02634203, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.