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Which PAH treatment strategy works better: adding a third drug or increasing the dose?

NCT ID NCT07713914

Disease control Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study compares two ways to intensify treatment for people with pulmonary arterial hypertension (PAH) who are not doing well enough on standard dual therapy. One group adds a third type of medication (a prostacyclin pathway agent), while the other group increases the dose of their existing sildenafil. The goal is to see which approach helps more patients improve their risk category within 3 to 6 months.

What this could mean

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

Active substance
prostacyclin pathway agent (inhaled iloprost or oral selexipag) or sildenafil dose optimization
What this could lead to
If successful, this study could show that adding a prostacyclin pathway agent is more effective than simply increasing the sildenafil dose for improving risk status in PAH patients.
What could go wrong
This is a relatively small, open-label trial, so results may be influenced by bias. The benefit of triple therapy over dose optimization may be modest or not apply to all 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 196 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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: * Age ≥18 years * Diagnosis of pulmonary arterial hypertension (PAH, Group 1) confirmed according to accepted clinical and hemodynamic criteria * Stable treatment with an endothelin receptor antagonist in combination with sildenafil prior to randomization * Classified as intermediate-low, intermediate-high, or high risk according to the COMPERA 2.0 four-stratum model * Clinical indication for therapeutic escalation * Availability for follow-up assessment between 3 and 6 months after randomization * Ability to provide written informed consent Exclusion Criteria: * Participation in another interventional clinical trial that mandates treatment modification * Known contraindication to prostacyclin pathway agents (including iloprost or selexipag) * Known contraindication to sildenafil dose escalation * Pregnancy or breastfeeding * Women of childbearing potential not using effective contraception * Any clinical condition that, in the investigator's judgment, would interfere with study participation or outcome assessment

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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 (PAH)

How to take part

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

  1. The places running it

    1 site. 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

  • Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo

    RECRUITING

    São Paulo, São Paulo, 04551-060, Brazil

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