Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension.

NCT07537517 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-04-17

No results posted yet for this study

Summary

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.

Conditions

  • Pulmonary Hypertension Due to Left Heart Disease
  • Pulmonary Hypertension (PH)
  • Heart Failure

Sponsors & Collaborators

  • Fundacion para la Innovacion en Biomedicina (FIBMED)

    collaborator OTHER
  • Instituto de Investigación Sanitaria Gregorio Marañón

    collaborator OTHER
  • Hospital General Universitario Gregorio Marañon

    lead OTHER

Principal Investigators

  • Ana I Fernandez-Avila, PhD · Institoto de Investigación Gregorio Marañón

  • Carlos Ortiz, MD, PhD · Hospital GU Gregorio Marañón

  • Jorge Martinez-Solano, MD; PhD · Hospital GU Gregorio Marañón

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-11-01
Completion
2028-12-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07537517 on ClinicalTrials.gov