Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension.
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension Due to Left Heart Disease, Pulmonary Hypertension (PH), Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the BMPR2-Activin Signaling Pathway as a Key Mediator in Group II Pulmonary Hypertension. BREATHE-PH Study
Overview
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.
Primary outcome measures
- Pulmonary vascular resistence [Time frame: 12 months]
- BMPR2 -activin expression [Time frame: 12 months]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital GU Gregorio Marañón — Madrid
Identifiers
NCT: NCT07537517 · BREATHE