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NCT Number: NCT07537517

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital GU Gregorio Marañón

Madrid, 28007, Spain

Location status: Recruiting

Location contact

Carlos Ortiz, MD, PhD

CONTACT

Jorge Martinez-Solano, MD, PhD

CONTACT

[email protected]

+3466294110

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Pulmonary vascular resistence

    Time frame: 12 months

    Pulmonary vascular resistence will be assesed 12 months after inclussion

  2. BMPR2 -activin expression

    Time frame: 12 months

    BMPR2-activine pathway will be determinaned to correlate with PH

Study contacts

Contact information is provided by the study sponsor or research team.

Ana I Fernandez-Avila, PhD

CONTACT

[email protected]

+34650413943

Jorge Martinez-Solano, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Gregorio Marañon

Other

Collaborators

  • Fundacion para la Innovacion en Biomedicina (FIBMED)
  • Instituto de Investigación Sanitaria Gregorio Marañón

Registry information

Official study title

Evaluation of the BMPR2-Activin Signaling Pathway as a Key Mediator in Group II Pulmonary Hypertension. BREATHE-PH Study

Acronym: BREATHE-PH

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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