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

NCT07537517 · Hospital General Universitario Gregorio Marañon
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Official title
Evaluation of the BMPR2-Activin Signaling Pathway as a Key Mediator in Group II Pulmonary Hypertension. BREATHE-PH Study
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.
Eligibility criteria
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)
Study design
Enrollment target: 150 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-11-01
Estimated completion: 2028-12-31
Last updated: 2026-04-17
Primary outcomes
  • Pulmonary vascular resistence (12 months)
  • BMPR2 -activin expression (12 months)
Sponsor
Hospital General Universitario Gregorio Marañon · other
With: Fundacion para la Innovacion en Biomedicina (FIBMED), Instituto de Investigación Sanitaria Gregorio Marañón
Contacts & investigators
ContactAna I Fernandez-Avila, PhD · contact · afernandeza.externo@salud.madrid.org · +34650413943
ContactJorge Martinez-Solano, MD, PhD · contact · jmsolano@salud.madrid.org
InvestigatorAna I Fernandez-Avila, PhD · principal_investigator, Institoto de Investigación Gregorio Marañón
InvestigatorCarlos Ortiz, MD, PhD · principal_investigator, Hospital GU Gregorio Marañón
InvestigatorJorge Martinez-Solano, MD; PhD · principal_investigator, Hospital GU Gregorio Marañón
All locations (1)
Hospital GU Gregorio MarañónRecruiting
Madrid, Madrid, Spain
Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension. · TrialPath