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

NCT07537517 | Recruiting

• 1 other identifier: BREATHE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

BMPR2; Activin; cardiac transplant; pulomnary hypertension II; gene expression; microRNAs

Outcome Measures

Primary Outcomes (2)

• Pulmonary vascular resistence

  Pulmonary vascular resistence will be assesed 12 months after inclussion

  12 months

• BMPR2 -activin expression

  BMPR2-activine pathway will be determinaned to correlate with PH

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Older that 18 years
• Heart failled patients with clinical indication for invasive hemodynamic assessment
• Written consent

You may not qualify if:

• Refulsl to sign the infomred consent
• Presence of iodinated contrast allergy
• Ineligibility for HT (for BREATHE-CT substudy)

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead
• Fundacion para la Innovacion en Biomedicina (FIBMED): collaborator
• Instituto de Investigación Sanitaria Gregorio Marañón: collaborator

Study Sites (1)

Hospital GU Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, cardiectomy pieces

MeSH Terms

Conditions

Hypertension, Pulmonary; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Officials

• Ana I Fernandez-Avila, PhD

  Institoto de Investigación Gregorio Marañón

  PRINCIPAL INVESTIGATOR

• Carlos Ortiz, MD, PhD

  Hospital GU Gregorio Marañón

  PRINCIPAL INVESTIGATOR

• Jorge Martinez-Solano, MD; PhD

  Hospital GU Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana I Fernandez-Avila, PhD

CONTACT

+34650413943; afernandeza.externo@salud.madrid.org

Jorge Martinez-Solano, MD, PhD

CONTACT

jmsolano@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Group Leader

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 17, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

ES (1)