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Can lung patients ditch their meds after procedure? new trial investigates

NCT ID NCT07644377

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 4 times

Summary

This study looks at people with a rare lung condition called CTEPH who have done well after a procedure (balloon angioplasty) and are taking a drug called riociguat. The goal is to see if stopping the drug is as safe as continuing it. About 150 participants will be randomly assigned to stop or continue riociguat and be followed for at least a year to check for worsening health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
riociguat
What this could lead to
If successful, this could show that many CTEPH patients can safely stop taking riociguat after balloon angioplasty, reducing medication burden and side effects.
What could go wrong
This is a Phase 3 trial, but it's still early and small (150 participants). Stopping the drug might lead to worsening symptoms or complications in some patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. WHO FC I or II 2. Pulmonary vascular resistance (PVR) \< 3 Wood units 3. Mean pulmonary artery pressure (mPAP) \< 30 mmHg * 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 Exclusion Criteria: * 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) * 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

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Conditions

The condition(s) this trial relates to.

chronic thromboembolic pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CTEPH

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Angers

    Angers, 49000, France

  • CHU Caen

    Caen, 14034, France

  • CHU Dijon Bourgogne

    Dijon, 21000, France

  • CHU Grenoble Alpes

    Grenoble, 38700, France

  • CHU Montpellier

    Montpellier, 34295, France

  • CHU Poitiers

    Poitiers, 86000, France

  • CHU Rouen

    Rouen, 76031, France

  • CHU Saint Etienne

    Saint-Etienne, 42270, France

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Brabois

    Vandœuvre-lès-Nancy, 54500, France

  • Hôpital Bretonneau

    Tours, 37044, France

  • Hôpital Européen Georges Pompidou

    Paris, 75015, France

  • Hôpital Gabriel Montpied

    Clermont-Ferrand, 63000, France

  • Hôpital Haut Levêque

    Bordeaux, 33600, France

  • Hôpital Larrey

    Toulouse, 31059, France

  • Hôpital Laënnec

    Nantes, 44800, France

  • Hôpital Nord

    Marseille, 13915, France

  • Hôpital Pontchaillou

    Rennes, 35000, France

  • Hôpital de la Cavale blanche

    Brest, 29200, France

  • Hôpital de la Timone

    Marseille, 13005, France

  • Institut Cœur-Poumon

    Lille, 59037, France

  • Nouvel Hôpital Civil

    Strasbourg, 67091, France

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