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New combo therapy aims to ease strain on heart in rare lung condition

NCT ID NCT05140525

Disease control Sponsor: Dr Sudarshan Rajagopal 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether combining two medications (Riociguat and Macitentan) with a balloon procedure to open blocked lung arteries can improve heart function in people with chronic thromboembolic pulmonary hypertension (CTEPH). The trial enrolls 15 adults who cannot have surgery or still have symptoms after surgery. The goal is to see if this approach helps the right side of the heart pump more efficiently.

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

7 people

The number who actually took part.

Started

Jan 2025

Finished

May 2026

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: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Age ≥ 18 years' old 2. Diagnosis of CTEPH 3. Not a candidate for PTE 4. Candidate for BPA based on suitable anatomy and disease burden 5. Treatment-naïve (no CTEPH or pulmonary arterial hypertension (PAH)-specific medical therapies) with plans for initiation of CTEPH/PAH-specific medical therapy and treatment with BPA. 6. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed). Exclusion Criteria: * Subjects presenting with any of the following will not be included in the trials: 1. Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy) 2. Sarcoidosis 3. Active cancer 4. Sickle cell anemia 5. Liver disease (Childs-Pugh class C) 6. Prisoners 7. Pregnant, planning pregnancy or lactating 8. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine) 9. Contraindication to riociguat or macitentan 10. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

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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

Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

More trials for these conditions

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