Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital General Universitario Gregorio Marañon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Older that 18 years
Heart failled patients with clinical indication for invasive hemodynamic assessment
Written consent
Disqualifiers
Refulsl to sign the infomred consent
Presence of iodinated contrast allergy
Ineligibility for HT (for BREATHE-CT substudy)
Trial population
The study cohort will consist of 150 patients with heart failure (HF) of diverse etiologies (estimated: 70 with PH-LHD and 80 without PH-LHD) who require invasive hemodynamic evaluation by right heart catheterization (RHC). This cohort includes patients with a clinical indication for RHC: advanced HF patients being evaluated for heart transplantation or ventricular assist devices; patients hospitalized for severe acute HF decompensation; or patients undergoing evaluation prior to surgical or percutaneous valvular intervention. The BREATHE-CT substudy will include 40 patients with advanced HF selected from the main cohort who are listed for heart transplantation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Pulmonary vascular resistence
Pulmonary vascular resistence will be assesed 12 months after inclussion
Time frame
12 months2
BMPR2 -activin expression
BMPR2-activine pathway will be determinaned to correlate with PH
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital General Universitario Gregorio Marañon
Lead sponsor
Fundacion para la Innovacion en Biomedicina (FIBMED)
Collaborator
Instituto de Investigación Sanitaria Gregorio Marañón
Collaborator
Source ClinicalTrials.gov