An observational study in Pulmonary Hypertension Due to Left Heart Disease, Pulmonary Hypertension (PH) and Heart Failure, sponsored by Hospital General Universitario Gregorio Marañon. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Hospital General Universitario Gregorio Marañon · Observational
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.
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.
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.
Exclusion Criteria:
Pulmonary vascular resistence
Pulmonary vascular resistence will be assesed 12 months after inclussion
Time frame: 12 months
BMPR2 -activin expression
BMPR2-activine pathway will be determinaned to correlate with PH
Time frame: 12 months
Plan to share: Undecided — The study is single-center; however, depending on the results obtained, data may be shared with investigators working in the same research field. A formal data-sharing plan will be developed and described at a later stage if deemed necessary
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital General Universitario Gregorio Marañon