Evaluation of the BMPR2-Activin Signaling Pathway as a Key Mediator in Group II Pulmonary Hypertension. BREATHE-PH Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pulmonary vascular resistence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older that 18 years
- •Heart failled patients with clinical indication for invasive hemodynamic assessment
- •Written consent
排除标准
- •Refulsl to sign the infomred consent
- •Presence of iodinated contrast allergy
- •Ineligibility for HT (for BREATHE-CT substudy)
结局指标
主要结局
Pulmonary vascular resistence
时间窗: 12 months
Pulmonary vascular resistence will be assesed 12 months after inclussion
BMPR2 -activin expression
时间窗: 12 months
BMPR2-activine pathway will be determinaned to correlate with PH
次要结局
未报告次要终点
研究者
Javier Bermejo Thomas
Research Group Leader
Hospital General Universitario Gregorio Marañon