Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension.
Recruiting · NCT07537517 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hospital General Universitario Gregorio Marañon
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Hospital GU Gregorio Marañón - Madrid, Madrid, Spain