Pulmonary Hypertension Due to Left Heart DiseaseBREATHE-PHNCT07537517
Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension.
An observational study of Pulmonary Hypertension Due to Left Heart Disease and Pulmonary Hypertension (PH), run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
Previous data from our group showed reduced BMPR2 isoform A in pulmonary hypertension associated with left heart disease (PH-LHD) of valvular origin. Focusing on dysregulation of the BMPR2-activin pathway, a key regulator of vascular homeostasis, this project uses a multimodal approach combining molecular biology… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension Due to Left Heart Disease, Pulmonary Hypertension (PH), Heart Failure
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2025to 31 Dec 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Older that 18 years
- Heart failled patients with clinical indication for invasive hemodynamic assessment
- Written consent
Who cannot join
- Refulsl to sign the infomred consent
- Presence of iodinated contrast allergy
- Ineligibility for HT (for BREATHE-CT substudy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jorge Martinez-Solano, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital GU Gregorio Marañón
Madrid, Madrid, 28007
Jorge Martinez-Solano, MD, PhD, +3466294110, jmsolano@salud.madrid.org
Carlos Ortiz, MD, PhD
About this study
Official title: Evaluation of the BMPR2-Activin Signaling Pathway as a Key Mediator in Group II Pulmonary Hypertension. BREATHE-PH Study
Previous data from our group showed reduced BMPR2 isoform A in pulmonary hypertension associated with left heart disease (PH-LHD) of valvular origin.
Focusing on dysregulation of the BMPR2-activin pathway, a key regulator of vascular homeostasis, this project uses a multimodal approach combining molecular biology, advanced cardiac imaging, and histology.
Read more
Its aim is to determine the role of the BMPR2-activin pathway in the development and regression of PH-LHD.
We will conduct a prospective observational study with 1-year follow-up in 150 heart failure patients of different etiologies undergoing hemodynamic assessment.
Clinical parameters, biomarkers, molecular profiles, and hemodynamic/echocardiographic variables will be analyzed.
A nested substudy in 40 heart transplant candidates will include thoracic CT for vascular morphometric analysis and histological correlation in explanted hearts versus healthy controls.
We will also assess reversibility of vascular remodeling one year after transplantation.
Results may redefine PH-LHD classification, enable phenotypic precision-medicine models, guide targeted therapies such as activin inhibitors, and refine transplant criteria in combined pulmonary hypertension.
Read the detailed description
This is a longitudinal observational study involving patients with heart failure (HF), including a substudy of advanced HF patients awaiting heart transplantation (BREATHE-CT).
The main cohort will include 150 HF patients of diverse etiologies undergoing invasive hemodynamic assessment by right heart catheterization.
Approximately 70 patients are expected to have PH-LHD and 80 will not. Eligible participants include advanced HF patients assessed for heart transplantation or ventricular assist devices, patients hospitalized for severe acute HF decompensation, and those undergoing pre-valvular intervention evaluation. The BREATHE-CT substudy will include 40 advanced HF patients selected from the main cohort and listed for heart transplantation.
Eligibility requires fulfillment of inclusion criteria and written informed consent.
Advanced HF and pulmonary hypertension classification will follow current European Society of Cardiology guidelines.
To improve representativeness, the study prioritizes inclusion of historically underrepresented groups, particularly women, given their increased risk for pulmonary hypertension.
- Conditions
- Pulmonary Hypertension Due to Left Heart Disease, Pulmonary Hypertension (PH), Heart Failure
- Keywords
- BMPR2, Activin, cardiac transplant, pulomnary hypertension II, gene expression, microRNAs
- Medical subject headings
- Hypertension, Pulmonary, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary vascular resistence
Pulmonary vascular resistence will be assesed 12 months after inclussion
Measured: 12 months
BMPR2 -activin expression
BMPR2-activine pathway will be determinaned to correlate with PH
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Nov 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension Due to Left Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion para la Innovacion en Biomedicina (FIBMED), Instituto de Investigación Sanitaria Gregorio Marañón
- Responsible party
- Principal investigator, Javier Bermejo Thomas, Hospital General Universitario Gregorio Marañon
- Investigators
- Ana I Fernandez-Avila, PhD, Principal investigator, Institoto de Investigación Gregorio MarañónCarlos Ortiz, MD, PhD, Principal investigator, Hospital GU Gregorio MarañónJorge Martinez-Solano, MD; PhD, Principal investigator, Hospital GU Gregorio Marañón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537517
- Sponsor's protocol ID
- BREATHE
- Acronym
- BREATHE-PH
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study is single-center; however, depending on the results obtained, data may be shared with investigators working in the same research field. A formal data-sharing plan will be developed and described at a later stage if deemed necessary
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the BMPR2-Activin Signaling Pathway as a Key Mediator in Group II Pulmonary Hypertension. BREATHE-PH Study
- ClinicalTrials.gov ID
- NCT07537517
- Acronym / sponsor ID
- BREATHE-PH / BREATHE
- Conditions
- Pulmonary Hypertension Due to Left Heart Disease, Pulmonary Hypertension (PH), Heart Failure
- Keywords
- BMPR2, Activin, cardiac transplant, pulomnary hypertension II, gene expression, microRNAs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Fundacion para la Innovacion en Biomedicina (FIBMED), Instituto de Investigación Sanitaria Gregorio Marañón
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous data from our group showed reduced BMPR2 isoform A in pulmonary hypertension associated with left heart disease (PH-LHD) of valvular origin.
Focusing on dysregulation of the BMPR2-activin pathway, a key regulator of vascular homeostasis, this project uses a multimodal approach combining molecular biology, advanced cardiac imaging, and histology.
Its aim is to determine the role of the BMPR2-activin pathway in the development and regression of PH-LHD.
We will conduct a prospective observational study with 1-year follow-up in 150 heart failure patients of different etiologies undergoing hemodynamic assessment.
Clinical parameters, biomarkers, molecular profiles, and hemodynamic/echocardiographic variables will be analyzed.
A nested substudy in 40 heart transplant candidates will include thoracic CT for vascular morphometric analysis and histological correlation in explanted hearts versus healthy controls.
We will also assess reversibility of vascular remodeling one year after transplantation.
Results may redefine PH-LHD classification, enable phenotypic precision-medicine models, guide targeted therapies such as activin inhibitors, and refine transplant criteria in combined pulmonary hypertension.
Detailed description
This is a longitudinal observational study involving patients with heart failure (HF), including a substudy of advanced HF patients awaiting heart transplantation (BREATHE-CT).
The main cohort will include 150 HF patients of diverse etiologies undergoing invasive hemodynamic assessment by right heart catheterization.
Approximately 70 patients are expected to have PH-LHD and 80 will not. Eligible participants include advanced HF patients assessed for heart transplantation or ventricular assist devices, patients hospitalized for severe acute HF decompensation, and those undergoing pre-valvular intervention evaluation. The BREATHE-CT substudy will include 40 advanced HF patients selected from the main cohort and listed for heart transplantation.
Eligibility requires fulfillment of inclusion criteria and written informed consent.
Advanced HF and pulmonary hypertension classification will follow current European Society of Cardiology guidelines.
To improve representativeness, the study prioritizes inclusion of historically underrepresented groups, particularly women, given their increased risk for pulmonary hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Older that 18 years
- Heart failled patients with clinical indication for invasive hemodynamic assessment
- Written consent
Key exclusion criteria (3 listed)
- Refulsl to sign the infomred consent
- Presence of iodinated contrast allergy
- Ineligibility for HT (for BREATHE-CT substudy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary vascular resistence
Time frame: 12 months
Pulmonary vascular resistence will be assesed 12 months after inclussion
BMPR2 -activin expression
Time frame: 12 months
BMPR2-activine pathway will be determinaned to correlate with PH
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Undecided. The study is single-center; however, depending on the results obtained, data may be shared with investigators working in the same research field. A formal data-sharing plan will be developed and described at a later stage if deemed necessary
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jorge Martinez-Solano, MD, PhD contact
Ana I Fernandez-Avila, PhD principal investigator
Institoto de Investigación Gregorio Marañón
Carlos Ortiz, MD, PhD principal investigator
Hospital GU Gregorio Marañón
Jorge Martinez-Solano, MD; PhD principal investigator
Hospital GU Gregorio Marañón
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension Due to Left Heart Disease and Pulmonary Hypertension (PH), run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana I Fernandez-Avila, PhD (+34650413943, afernandeza.externo@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary vascular resistence (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.