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NCT07537517Recruiting

Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension.

Evaluation of the BMPR2-Activin Signaling Pathway as a Key Mediator in Group II Pulmonary Hypertension. BREATHE-PH Study

Source: ClinicalTrials.gov · Last updated 17 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
9 Apr 2026
Start date
1 Nov 2025
Primary completion date
1 Nov 2027
Lead sponsor
Hospital General Universitario Gregorio Marañon
NCT number
NCT07537517

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 1 Nov 2025 to the primary completion date, 1 Nov 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of iodinated contrast allergy

Other

  • Refulsl to sign the infomred consent
  • Ineligibility for HT (for BREATHE-CT substudy)

Who the study is looking for

  • Older that 18 years
  • Heart failled patients with clinical indication for invasive hemodynamic assessment
  • Written consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital GU Gregorio Marañón
Coordinator of this site? Confirm its status
MadridSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.