Actively Recruiting
Evaluation of the BMPR2-Activin Signaling Pathway as a Key Mediator in Group II Pulmonary Hypertension BREATHE-PH Study
Led by Hospital General Universitario Gregorio Marañon · Updated on 2026-04-17
150
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
H
Hospital General Universitario Gregorio Marañon
Lead Sponsor
F
Fundacion para la Innovacion en Biomedicina (FIBMED)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the BMPR2-activin signaling pathway in patients with pulmonary hypertension due to left heart disease (PH-LHD), particularly focusing on its role in vascular health and disease progression. This observational study aims to understand how this pathway contributes to the development and possible reversal of PH-LHD, using advanced molecular biology techniques, cardiac imaging, and tissue analysis. The study includes heart failure patients of various causes and hopes to enhance precision medicine approaches and treatment strategies for PH-LHD. The study will enroll 150 heart failure patients who will undergo invasive hemodynamic assessment through right heart catheterization. Among these, about 70 are expected to have PH-LHD, while 80 will not. A subgroup of 40 patients listed for heart transplantation will participate in a detailed substudy involving thoracic CT scans and histological examination of explanted hearts. Researchers will analyze clinical data, biomarkers, molecular profiles, and imaging to assess vascular remodeling before and one year after transplantation. Participants will be followed for one year, during which clinical evaluations, biomarker collection, molecular studies, and hemodynamic and echocardiographic measurements will be performed. The primary outcomes include pulmonary vascular resistance and BMPR2-activin expression after 12 months. The study prioritizes inclusion of underrepresented groups, especially women, and aims to refine PH-LHD classifications and treatment criteria based on its findings.
CONDITIONS
Brief Title
Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Older that 18 years
- Heart failled patients with clinical indication for invasive hemodynamic assessment
- Written consent
You will not qualify if you...
- Refulsl to sign the infomred consent
- Presence of iodinated contrast allergy
- Ineligibility for HT (for BREATHE-CT substudy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo invasive hemodynamic assessment by right heart catheterization as part of the evaluation of their heart failure condition.
1 visit (in-person)
Duration - Up to 12 months
Participants are observed over time to assess pulmonary vascular resistance and BMPR2-activin expression related to pulmonary hypertension and heart failure.
Follow-up visits scheduled as per clinical assessment
Trial Site Locations
Total: 1 location
1
Hospital GU Gregorio Marañón
Madrid, Madrid, Spain, 28007
Actively Recruiting
Research Team
A
Ana I Fernandez-Avila, PhD
J
Jorge Martinez-Solano, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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