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BREATHE-PH study aims to unlock secrets of lung blood pressure in heart failure

NCT ID NCT07537517

Knowledge-focused Sponsor: Hospital General Universitario Gregorio Marañon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how a specific biological pathway (BMPR2-activin) affects pulmonary hypertension in people with left heart disease. Researchers will follow 150 heart failure patients for one year, using blood tests, imaging, and heart tissue analysis. The goal is to better understand the disease and find new ways to treat it.

What this could mean

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

What this could lead to
If successful, this study could redefine how pulmonary hypertension is classified and point toward new targeted therapies like activin inhibitors.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test any therapy, and results may not lead to immediate clinical changes.

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 150 people

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

Started

Nov 2025

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.

Who is studied

The study cohort will consist of 150 patients with heart failure (HF) of diverse etiologies (estimated: 70 with PH-LHD and 80 without PH-LHD) who require invasive hemodynamic evaluation by right heart catheterization (RHC). This cohort includes patients with a clinical indication for RHC: advanced HF patients being evaluated for heart transplantation or ventricular assist devices; patients hospitalized for severe acute HF decompensation; or patients undergoing evaluation prior to surgical or percutaneous valvular intervention. The BREATHE-CT substudy will include 40 patients with advanced HF selected from the main cohort who are listed for heart transplantation.

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: * Older that 18 years * Heart failled patients with clinical indication for invasive hemodynamic assessment * Written consent Exclusion Criteria: * Refulsl to sign the infomred consent * Presence of iodinated contrast allergy * Ineligibility for HT (for BREATHE-CT substudy)

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Conditions

The condition(s) this trial relates to.

heart failure pulmonary hypertension

As listed by the trial registrant

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

Heart failure Pulmonary hypertension (PH) Pulmonary hypertension due to left heart disease

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

  • Hospital GU Gregorio Marañón

    RECRUITING

    Madrid, Madrid, 28007, Spain

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