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Small study explores real-world switch to riociguat for tough PAH cases

NCT ID NCT07374302

Knowledge-focused Sponsor: Caio Júlio César dos Santos Fernandes 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study will review medical records of 15 adults with pulmonary arterial hypertension (PAH) who switched from one medication (a PDE5 inhibitor) to riociguat while already on triple therapy. The goal is to see if this switch improves exercise ability, symptoms, and blood markers at 6 months. Because it is a retrospective chart review, no new treatments are given, and the results will only describe what happened in routine care.

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 results are positive, this could suggest that switching to riociguat is a useful option for PAH patients not doing well on standard triple therapy.
What could go wrong
This is a very small (15 people), single-center, retrospective study, so results may not apply widely. It only observes routine care, so it cannot prove cause and effect.

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.

Participants

About 15 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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.

Who is studied

The study population includes adult patients with pulmonary arterial hypertension receiving triple therapy who switched from a phosphodiesterase-5 inhibitor to riociguat in routine clinical practice at a specialized referral center. All patients were followed using retrospective data from medical records to assess clinical outcomes, safety, and treatment persistence. No study-related interventions were performed.

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 * Adults aged 18 years or older. * Confirmed diagnosis of pulmonary arterial hypertension (Group 1). * Treatment with triple therapy including an endothelin receptor antagonist, a prostacyclin pathway agent, and a phosphodiesterase-5 inhibitor for at least 12 weeks. * Switch from a phosphodiesterase-5 inhibitor to riociguat as part of routine clinical care. * Availability of minimum data to assess the primary outcome at 6 months. Exclusion Criteria * Concomitant use of phosphodiesterase-5 inhibitors and riociguat. * Inability to confirm vital status or hospitalization outcomes within 6 months. * Participation in an interventional clinical trial that mandated the treatment switch.

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

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

Pulmonary arterial hypertension

How to take part

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  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.