CTEPHPhase 3DIRECTIONNCT07644377
Discontinuation Versus Continuation of Riociguat Monotherapy in Chronic Thromboembolic Pulmonary Hypertension Successfully Treated With Balloon Pulmonary Angioplasty
A Phase 3 study testing Discontinuation of riociguat in people with CTEPH, run by Assistance Publique - Hôpitaux de Paris at 22 sites in France.
Trial summary
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare but severe complication of acute pulmonary embolism, characterized by persistent obstruction of the pulmonary arteries by organized thrombi and secondary microvasculopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CTEPH
- What is being tested?
- Discontinuation of riociguat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 22 sitesFrance
- Study dates
- 1 Nov 2026to 31 Jan 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Signed informed consent and willingness to accept either discontinuation or continuation of riociguat monotherapy
- 2. Age ≥18 years
- 3. Diagnosis of inoperable CTEPH or persistent PH after PEA, with achievement of therapeutic goals following BPA, defined as:
- WHO FC I or II
- Pulmonary vascular resistance (PVR) < 3 Wood units
- Mean pulmonary artery pressure (mPAP) < 30 mmHg
Show all 10Show fewer
- 4. Treatment with riociguat monotherapy for ≥6 months, with stable dose for ≥3 months prior to enrollment
- 5. Last BPA session performed ≥6 months prior to enrollment
- 6. 6-minute walk distance (6MWD) ≥ 150 meters
- 7. For women of childbearing potential: highly effective contraception
Who cannot join
- 1. Background treatment with any PH-targeted therapy other than riociguat, (e.g., any endothelin receptor antagonist (ERA), phosphodiesterase-5 inhibitor (PDE-5i), parenteral prostanoids, prostacyclin receptor agonist)
- 2. Post-capillary pulmonary hypertension, defined as pulmonary artery wedge pressure (PAWP) > 15 mmHg
- 3. Significant obstructive or restrictive lung disease, defined as:
- FEV₁ < 60% predicted, with FEV₁/FVC < 65%
- and/or total lung capacity (TLC) < 60% predicted
- or known significant chronic lung disease on imaging (e.g., interstitial lung disease, emphysema)
Show all 23Show fewer
- 4. Severe hepatic impairment, defined as:
- Child-Pugh class B or C
- and/or liver aminotransferase levels > 3× upper limit of normal (ULN)
- 5. Severe renal impairment (estimated creatinine clearance ≤ 30 mL/min/1.73 m²).
- 6. Left heart failure with left ventricular ejection fraction (LVEF) < 40%
- 7. Ongoing or planned treatment with organic nitrates.
- 8. Concomitant treatment with strong cytochrome P450 3A4 (CYP3A4) inducers (e.g., rifabutin, rifampicin, carbamazepine, phenobarbital, phenytoin, St. John's wort)
- 9. Concomitant treatment with strong multi pathway P-glycoprotein (P-gp)/ breast cancer resistance protein (BCRP) inhibitors (e.g., lopinavir/ritonavir).
- 10. Treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir) or a moderate dual CYP3A4/CYP2C9 inhibitor (e.g., fluconazole, amiodarone) or co-administration of a combination of moderate CYP3A4 and moderate CYP2C9 inhibitors.
- 11. History of life-threatening hemoptysis (>100 mL within 24 hours) or prior bronchial artery embolization for hemoptysis
- 12. Pregnancy, breastfeeding, or intention to become pregnant during the study period
- 13. Severe comorbidities or underlying conditions with an anticipated life expectancy < 12 months, including active malignancy with localized or metastatic disease
- 14. Lack of coverage by national health or social security systems
- 15. Alcohol abuse, as determined by the investigator
- 16. Any condition or factor likely to interfere with protocol compliance, in the opinion of the investigator
- 17. Patient under guardianship or curatorship
- 18. Participation in another interventional trial or being in the exclusion period following a previous research involving the human person
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
France22 sites
CHU Angers
Angers, 49000
Frédéric GAGNADOUX, PUPH, +33241353695, frgagnadoux@chu-angers.fr
Hôpital Haut Levêque
Bordeaux, 33600
François PICARD, PUPH, +33557656267, francois.picard@chubordeaux.fr
Hôpital de la Cavale blanche
Brest, 29200
Cécile TROMEUR, PUPH, +33230337602, cecile.tromeur@chu-brest.fr
CHU Caen
Caen, 14034
Emmanuel BERGOT, PUPH, +33331064677, bergot-e@chu-caen.fr
Hôpital Gabriel Montpied
Clermont-Ferrand, 63000
Romain TRESORIER, MD, +33473751412, rtresorier@chuclermontferrand.fr
CHU Dijon Bourgogne
Dijon, 21000
Nicolas FAVROLT, MD, +33380293772, Nicolas.favrolt@chu-dijon.fr
CHU Grenoble Alpes
Grenoble, 38700
Hélène BOUVAIST, MD, +33476768888, hbouvaist@chu-grenoble.fr
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Mitja JEVNIKAR, MD, +33 145217876, mitja.jevnikar@aphp.fr
Institut Cœur-Poumon
Lille, 59037
Nicolas LAMBLIN, PUPH, +33320445038, Nicolas.lamblin@chru-lille.fr
Hôpital de la Timone
Marseille, 13005
Sébastien RENARD, MD, +33491385978, sebastien.renard@ap-hm.fr
Hôpital Nord
Marseille, 13915
Martine REYNAUD GAUBERT, PUPH, +33491966145, martine.reynaud@ap-hm.fr
CHU Montpellier
Montpellier, 34295
Arnaud BOURDIN, PUPH, a-bourdin@chu-montpellier.fr
Hôpital Laënnec
Nantes, 44800
Delphine HOREAU LANGLARD, MD, +33240165229, delphine.horeaulanglard@chu-nantes.fr
Hôpital Européen Georges Pompidou
Paris, 75015
Olivier SANCHEZ, PUPH, +33 156093461, olivier.sanchez@aphp.fr
CHU Poitiers
Poitiers, 86000
Magali CROQUETTE, MD, +33549443570, magali.croquette@chu-poitiers.fr
Hôpital Pontchaillou
Rennes, 35000
Céline CHABANNE, MD, +33299282473, celine.chabanne@chu-rennes.fr
CHU Rouen
Rouen, 76031
Elise ARTAUD-MACARI, MD, +33232885992, Elise.artaud-macari@chu-rouen.fr
CHU Saint Etienne
Saint-Etienne, 42270
Laurent BERTOLETTI, PUPH, +33477127770, laurent.bertoletti@chu-st-etienne.fr
Nouvel Hôpital Civil
Strasbourg, 67091
Marianne RIOU, MD, +33369551145, marianne.riou@chru-strasbourg.fr
Hôpital Larrey
Toulouse, 31059
Elise NOEL SAVINA, MD, +33567771744, noel-savina.e@chu-toulouse.fr
Hôpital Bretonneau
Tours, 37044
Pascal MAGRO, PUPH, +33247478784, magro@med.univ-tours.fr
Hôpital Brabois
Vandœuvre-lès-Nancy, 54500
Ari CHAOUAT, PUPH, +33383154021, a.chaouat@chru-nancy.fr
About this study
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare but severe complication of acute pulmonary embolism, characterized by persistent obstruction of the pulmonary arteries by organized thrombi and secondary microvasculopathy. International guidelines recommend a multimodal approach combining pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA), and medical treatment with riociguat, to address the full spectrum of CTEPH lesions. BPA and riociguat are recommended for symptomatic patients with inoperable CTEPH or persistent pulmonary hypertension after PEA. Riociguat is administered before BPA to reduce periprocedural complications by improving pulmonary hemodynamics. While this pre-BPA strategy is well established, post-BPA management is poorly studied, especially in patients achieving therapeutic goals, defined as WHO functional class I or II and near-normal resting pulmonary hemodynamics (70 to 80% of cases). In such cases, riociguat monotherapy is often continued long-term, despite its cost, burden, and potential side effects, which may negatively impact patients' quality of life. Retrospective single-center studies suggest that discontinuation of medical treatment does not lead to significant clinical deterioration. Therefore, we propose conducting a multicenter trial using a PROBE (prospective, randomized, open-label, blinded endpoint) design and a Bayesian approach to test if stopping riociguat monotherapy after successful BPA is associated with an acceptably low risk of clinical worsening over a follow-up period of at least one year compared to continuation. The trial will also assess the cost-effectiveness of riociguat discontinuation.
- Conditions
- CTEPH
- Being tested
- Discontinuation of riociguat
- Keywords
- riociguat discontinuation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of riociguatDrug
Discontinuation of riociguat after randomization
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Discontinuation of riociguat Receives: Drug: Discontinuation of riociguat |
| Control group | No intervention | Continuation of riociguat |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether the discontinuation of riociguat monotherapy after successful BPA in CTEPH patients is associated with an acceptably low risk of clinical worsening compared to continuation
Clinical worsening which is the composite of :
- death due to any cause,
- hospitalisation due to worsening including : a) documented right heart failure, b) need for lung transplantation, c) need for intraveinous diuretics/inotropic support or d) need for parental prostanoids
- decline in 6 minutes walk distance by 15% from baseline, combined with WHO functional class III or IV
Measured: At the longest follow-up, minimum 12 months
Secondary outcomes (12)
To compare the effect of discontinuation versus continuation of riociguat monotherapy on 6-minute walk distance (6MWD)
Change from baseline in 6-minute walk distance (6MWD)
Measured: Month 3, 6, 12 and every 6 months with maximum of 48 months
To compare the effect of discontinuation versus continuation of riociguat monotherapy on WHO functionnal class
Change from baseline in WHO functionnal class
Measured: Month 3, 6, 12 and every 6 months with maximum of 48 months
To compare the effect of discontinuation versus continuation of riociguat monotherapy on WHO functionnal class
Change from baseline in Borg dyspnea
Measured: Month 3, 6, 12 and every 6 months with maximum of 48 months
To compare the effect of discontinuation versus continuation of riociguat monotherapy on other clinical measures of pulmonary hypertension
Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels
Measured: Month 3, 6, 12 and every 6 months with maximum of 48 months
To compare the effect of discontinuation versus continuation of riociguat monotherapy on pulmonary vascular resistance (PVR)
Change from baseline in Pulmonary vascular resistance (PVR)
Measured: Month 12
To compare the effect of discontinuation versus continuation of riociguat monotherapy on hemodynamic parameters :
Change from baseline in Right atrial pressure
Measured: Month 12
To compare the effect of discontinuation versus continuation of riociguat monotherapy on hemodynamic parameters
Change from baseline in Mean pulmonary arterial pressure (mPAP)
Measured: Month 12
To compare the effect of discontinuation versus continuation of riociguat monotherapy on hemodynamic parameters
Change from baseline in Cardiac output
Measured: Month 12
To compare the effect of discontinuation versus continuation of riociguat monotherapy on quality of life
Change from baseline in EQ-5D-5L questionnaire
Measured: Month 3, 6, 12 and every 6 months with maximum of 48 months
To compare the effect of discontinuation versus continuation of riociguat monotherapy on quality of life
Change from baseline in EmPHasis-10 questionnaire (scale from 0 (best) to 5 (worst)
Measured: Month 3, 6, 12 and every 6 months with maximum of 48 months
To assess the health economic impact of riociguat discontinuation
Incremental cost-effectiveness ratio (ICER), defined as the difference in in quality-adjusted life years (QALYS), for the strategy of riociguat monotherapy discontinuation from the perspective of the French public health system
Measured: At the longest follow-up, minimum 12 months
To assess treatment burden
Change from baseline in Treatment burden questionnaire
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTEPHStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter trial using a PROBE design conducted in patients with inoperable CTEPH or persistent PH after PEA, who have been receiving riociguat monotherapy for ≥6 months and have achieved therapeutic goals following BPA. Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups: * Experimental group: discontinuation of riociguat * Control group: continuation of riociguat Regular hospital visits will be conducted at months 3, 6, and 12, including WHO FC assessment, clinical examination, 6MWD, routine blood tests (including NT-proBNP), and quality of life assessment (EmPHasis-10 and EQ-5D-5L). At month 12, an RHC will be also performed to assess hemodynamic parameters. Thereafter, patients will be evaluated every 6 months until the last enrolled patient has completed the minimum 12-month follow-up. Adjudication of all clinical worsening events will be performed by an independent Clinical Event Committee (CEC)
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644377
- Sponsor's protocol ID
- APHP251608
- Other IDs
- 2026-525351-81-00
- Acronym
- DIRECTION
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation Versus Continuation of Riociguat Monotherapy in Chronic Thromboembolic Pulmonary Hypertension Successfully Treated With Balloon Pulmonary Angioplasty
- ClinicalTrials.gov ID
- NCT07644377
- Acronym / sponsor ID
- DIRECTION / APHP251608
- Conditions
- CTEPH
- Keywords
- riociguat discontinuation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 12 Jun 2026 (actual)
- 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 rare but severe complication of acute pulmonary embolism, characterized by persistent obstruction of the pulmonary arteries by organized thrombi and secondary microvasculopathy. International guidelines recommend a multimodal approach combining pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA), and medical treatment with riociguat, to address the full spectrum of CTEPH lesions. BPA and riociguat are recommended for symptomatic patients with inoperable CTEPH or persistent pulmonary hypertension after PEA. Riociguat is administered before BPA to reduce periprocedural complications by improving pulmonary hemodynamics. While this pre-BPA strategy is well established, post-BPA management is poorly studied, especially in patients achieving therapeutic goals, defined as WHO functional class I or II and near-normal resting pulmonary hemodynamics (70 to 80% of cases). In such cases, riociguat monotherapy is often continued long-term, despite its cost, burden, and potential side effects, which may negatively impact patients' quality of life. Retrospective single-center studies suggest that discontinuation of medical treatment does not lead to significant clinical deterioration. Therefore, we propose conducting a multicenter trial using a PROBE (prospective, randomized, open-label, blinded endpoint) design and a Bayesian approach to test if stopping riociguat monotherapy after successful BPA is associated with an acceptably low risk of clinical worsening over a follow-up period of at least one year compared to continuation. The trial will also assess the cost-effectiveness of riociguat discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter trial using a PROBE design conducted in patients with inoperable CTEPH or persistent PH after PEA, who have been receiving riociguat monotherapy for ≥6 months and have achieved therapeutic goals following BPA. Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups: * Experimental group: discontinuation of riociguat * Control group: continuation of riociguat Regular hospital visits will be conducted at months 3, 6, and 12, including WHO FC assessment, clinical examination, 6MWD, routine blood tests (including NT-proBNP), and quality of life assessment (EmPHasis-10 and EQ-5D-5L). At month 12, an RHC will be also performed to assess hemodynamic parameters. Thereafter, patients will be evaluated every 6 months until the last enrolled patient has completed the minimum 12-month follow-up. Adjudication of all clinical worsening events will be performed by an independent Clinical Event Committee (CEC)
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Discontinuation of riociguatDiscontinuation of riociguat |
| Control group | No intervention | –Continuation of riociguat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Signed informed consent and willingness to accept either discontinuation or continuation of riociguat monotherapy
- 2. Age ≥18 years
- 3. Diagnosis of inoperable CTEPH or persistent PH after PEA, with achievement of therapeutic goals following BPA, defined as:
- 4. Treatment with riociguat monotherapy for ≥6 months, with stable dose for ≥3 months prior to enrollment
- 5. Last BPA session performed ≥6 months prior to enrollment
Key exclusion criteria (23 listed)
- 1. Background treatment with any PH-targeted therapy other than riociguat, (e.g., any endothelin receptor antagonist (ERA), phosphodiesterase-5 inhibitor (PDE-5i), parenteral prostanoids, prostacyclin receptor agonist)
- 2. Post-capillary pulmonary hypertension, defined as pulmonary artery wedge pressure (PAWP) > 15 mmHg
- 3. Significant obstructive or restrictive lung disease, defined as:
- FEV₁ < 60% predicted, with FEV₁/FVC < 65%
- and/or total lung capacity (TLC) < 60% predicted
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 |
|---|---|---|
| Discontinuation of riociguatDiscontinuation of riociguat after randomization | Drug | Experimental group |
Primary outcome
To evaluate whether the discontinuation of riociguat monotherapy after successful BPA in CTEPH patients is associated with an acceptably low risk of clinical worsening compared to continuation
Time frame: At the longest follow-up, minimum 12 months
Clinical worsening which is the composite of : * death due to any cause, * hospitalisation due to worsening including : a) documented right heart failure, b) need for lung transplantation, c) need for intraveinous diuretics/inotropic support or d) need for parental prostanoids * decline in 6 minutes walk distance by 15% from baseline, combined with WHO functional class III or IV
12 secondary outcomes
To compare the effect of discontinuation versus continuation of riociguat monotherapy on 6-minute walk distance (6MWD)
Time frame: Month 3, 6, 12 and every 6 months with maximum of 48 months
To compare the effect of discontinuation versus continuation of riociguat monotherapy on WHO functionnal class
Time frame: Month 3, 6, 12 and every 6 months with maximum of 48 months
To compare the effect of discontinuation versus continuation of riociguat monotherapy on WHO functionnal class
Time frame: Month 3, 6, 12 and every 6 months with maximum of 48 months
To compare the effect of discontinuation versus continuation of riociguat monotherapy on other clinical measures of pulmonary hypertension
Time frame: Month 3, 6, 12 and every 6 months with maximum of 48 months
To compare the effect of discontinuation versus continuation of riociguat monotherapy on pulmonary vascular resistance (PVR)
Time frame: Month 12
To compare the effect of discontinuation versus continuation of riociguat monotherapy on hemodynamic parameters :
Time frame: Month 12
To compare the effect of discontinuation versus continuation of riociguat monotherapy on hemodynamic parameters
Time frame: Month 12
To compare the effect of discontinuation versus continuation of riociguat monotherapy on hemodynamic parameters
Time frame: Month 12
To compare the effect of discontinuation versus continuation of riociguat monotherapy on quality of life
Time frame: Month 3, 6, 12 and every 6 months with maximum of 48 months
To compare the effect of discontinuation versus continuation of riociguat monotherapy on quality of life
Time frame: Month 3, 6, 12 and every 6 months with maximum of 48 months
To assess the health economic impact of riociguat discontinuation
Time frame: At the longest follow-up, minimum 12 months
To assess treatment burden
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Discontinuation of riociguat in people with CTEPH, run by Assistance Publique - Hôpitaux de Paris at 22 sites 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 10 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mitja JEVNIKAR, MD (+33 145217876, mitja.jevnikar@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate whether the discontinuation of riociguat monotherapy after successful BPA in CTEPH patients is associated with an acceptably low risk of clinical worsening compared to continuation (time frame: At the longest follow-up, minimum 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.