BMPR2-Activin signaling in pulmonary hypertension from left heart disease
Official title: Evaluation of the BMPR2-Activin Signaling Pathway as a Key Mediator in Group II Pulmonary Hypertension. BREATHE-PH Study
Run by Hospital General Universitario Gregorio Marañon · NCT07537517 · Data updated 2026-11-12
This project will test whether changes in the BMPR2-activin pathway drive lung vessel disease in people with heart failure and pulmonary hypertension by following 150 patients for one year.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Hospital General Universitario Gregorio Marañon Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | November 1, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT07537517 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with heart failure who have a clinical indication for invasive hemodynamic assessment, including advanced heart‑failure patients evaluated for transplant or VAD, those hospitalized for acute decompensation, or patients undergoing pre‑valve intervention evaluation.
✕Probably not a fit
People without left-heart-related pulmonary hypertension, patients ineligible for contrast imaging, or those not undergoing invasive hemodynamic testing are unlikely to gain direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study will follow 150 adults with heart failure who undergo invasive hemodynamic assessment, collecting clinical data, biomarkers, molecular profiles, echocardiographic and hemodynamic measures over 12 months. A nested BREATHE-CT substudy of 40 transplant candidates will add thoracic CT morphometry and histological comparison of explanted hearts with controls. The multimodal approach combines molecular biology, advanced cardiac imaging, and histology to link pathway changes with vascular remodeling. Analyses will focus on the role of the BMPR2-activin pathway in the development and potential regression of pulmonary hypertension due to left heart disease.
Why it matters
Potential benefit: If successful, the project could reveal biomarkers and mechanisms that predict which patients' pulmonary vascular changes can reverse and point to new targets for therapy.
How similar studies have gone: BMPR2 pathway dysfunction is established in pulmonary arterial hypertension, but applying multimodal longitudinal human data to pulmonary hypertension due to left heart disease is relatively novel and less well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Hospital GU Gregorio Marañón
Madrid, Madrid, Spain Recruiting
Study contacts
- Principal investigator: Ana I Fernandez-Avila, PhD — Institoto de Investigación Gregorio Marañón
- Study coordinator: Ana I Fernandez-Avila, PhD
- Email: afernandeza.externo@salud.madrid.org
- Phone: +34650413943
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.