Redefining Pulmonary Hypertension Through Pulmonary Vascular Disease Phenomics (PVDOMICS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,195
- 试验地点
- 14
- 主要终点
- Precision based definitions of pulmonary vascular diseases (PVD)
研究概览
简要总结
It is recognized that patients with various forms of heart and lung disease exhibit varying degrees of pulmonary hypertension, pulmonary vascular remodeling, and right ventricular dysfunction. The genetic, molecular, and cellular processes driving these phenomena are not well understood. Rapid advances in high throughput omic methodology, combined with powerful bioinformatics and network biology capability, have created the opportunity to conduct studies that broadly search for homologies and differences across the spectrum of disease states associated with pulmonary hypertension, and determinants of the spectrum of right ventricular compensation that accompanies these conditions
详细描述
The protocol is designed to lead to new understanding of patients with pulmonary hypertension and right heart dysfunction, based on molecular, clinical, hemodynamic and radiographic characteristics. New classifications will be a product of association of these in depth phenotypic descriptions with specific molecular mechanisms of pathogenesis. The protocol will be implemented to lead to identification of both sub-phenotypes of lung vascular disease and to biomarkers of disease that may be useful for early diagnosis or for assessment of interventions to prevent or treat this condition.
A longitudinal study in a subset of the participants enrolled in the parent cross-sectional study will:
- Retest participants at a minimum 6 month interval from initial evaluation to collect a core set of clinical and OMICS features. This will include survival, clinical staging, clinical group assignment, 6-minute walk, echocardiography, and blood for a broad collection of selected OMICS tests, to include proteomics and other variables found to be informative in the initial set.
- Associate and compare OMICS data with clinical sets and OMICS clusters between baseline and follow-up interval, with attention to reproducibility, predictive capacity as biomarkers for diagnosis, disease progression, phenotypic changes, functional capacity, therapeutic response and survival.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cross-sectional (parent) study:
- •Inclusion Criteria:
- •Patients ages >18 years of age referred for right heart catheterization for further evaluation of known PVD or to be at risk for PVD due to established cardiac disease or pulmonary disease
- •Able to perform complete diagnostic testing listed subsequently (cardiac catheterization, echo, exercise test, PFT's, ECG, chest CT, quality of life questionnaires, ventilation/perfusion scan, cardiac MRI, body composition bioimpedance, and sleep study)
- •Subject signs informed consent to perform required testing for the protocol
排除标准
- •Dialysis dependent renal function; In the clinician's opinion, too ill to perform the protocol testing; Pregnant or nursing
- •Longitudinal study:
- •Inclusion Criteria:
- •Any PH, comparators or control participant previously enrolled in the parent PVDOMICS protocol with a minimum of six months post-enrollment
- •Dialysis dependent renal function since the parent study acceptable
- •Exclusion Criteria:
- •Participant Level 1 (clinic visit):
- •Transplant other than heart or lung
- •In the clinician's opinion, too ill to perform L-PVDOMICS testing even if limited testing.
- •Participants who withdrew from the parent PVDOMICS study
- •Pregnant or nursing
- •Concurrent participation in any investigational drug study or other clinical trial
- •Participant Level 2 (telephone visit):
- •Transplant other than heart or lung
- •Participants who withdrew from the parent PVDOMICS study
- •Participant Level 3 (medical chart review):
- •- Participants who withdrew from the parent PVDOMICS study
研究组 & 干预措施
Controls
Healthy controls No intervention as this is an observational study
干预措施: No Intervention (Other)
Pulmonary Vascular Disease
Pulmonary Vascular Disease at risk for pulmonary hypertension
干预措施: No Intervention (Other)
Pulmonary Hypertension
Those meeting WSPH/WHO group classifications 1-5 of pulmonary hypertension
干预措施: No Intervention (Other)
结局指标
主要结局
Precision based definitions of pulmonary vascular diseases (PVD)
时间窗: Over 5 years
OMICs analyses will be used to assign new class of PVD
次要结局
- Identification of biomarkers for PVD(5 years)