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临床试验/NCT07131241
NCT07131241招募中不适用

Research on Dynamic Risk Prediction for Patients With Pulmonary Hypertension Based on Multimodal Data Fusion: A Prospective Observational Study

First Affiliated Hospital of Fujian Medical University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Time to clinical worsening

研究概览

简要总结

Pulmonary hypertension (PH) is a progressive cardiopulmonary disease characterized by elevated pulmonary artery pressure and vascular remodeling, which leads to right heart failure and increased mortality. Despite advances in diagnostics, risk stratification remains limited due to the disease's heterogeneity. This study aims to develop and validate a dynamic risk prediction model for PH by integrating multimodal data-including echocardiography, Cardiac MRI, PET-MR, ECG, biomarkers, and clinical features-using advanced machine learning algorithms. The study will establish a prospective cohort of PH patients to explore predictive markers, stratify prognosis, and provide a scientific basis for early warning and individualized management.

详细描述

This is a prospective, observational cohort study designed to investigate dynamic risk prediction in patients diagnosed with pulmonary hypertension (PH). The study will collect multimodal clinical data-comprising imaging (echocardiography, cardiac MRI, PET-MR), electrocardiographic parameters, blood-based biomarkers, and demographic and clinical information-at baseline and follow-up intervals. The core objective is to develop a data fusion-based prognostic model capable of predicting adverse outcomes such as hospitalization, functional deterioration, or mortality. Machine learning methods will be employed to identify key predictive features. The model will be validated internally and externally across different subgroups. The study seeks to inform individualized risk-based decision-making and advance precision screening in PH care.

In addition, biospecimens will be collected to support comprehensive multi-omics profiling. Whole blood, serum, plasma, urine, and stool samples will be obtained and processed using standardized protocols. Blood-derived samples will be used for genomic, proteomic, metabolomic, and microRNA analyses; urine specimens will support metabolomic and renal biomarker assays; and stool samples will be used for gut microbiome sequencing. All biospecimens will be stored in a secure biobank and linked with clinical, imaging, and longitudinal follow-up data using de-identified subject codes to enable integrated multimodal analyses and facilitate future exploratory investigations of disease mechanisms and biomarker discovery.

Health economic evaluation, including cost-effectiveness and budget impact analyses, will be conducted using collected data on healthcare resource utilization, direct medical costs, and clinical outcomes to inform future policy and reimbursement decision-making.

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

入选标准

  • Adults aged 18 years or older
  • Pulmonary artery systolic pressure (PASP) ≥35 mmHg as estimated by echocardiography
  • Provided written informed consent

排除标准

  • Severe hepatic or renal insufficiency
  • Malignancy under active treatment
  • Severe infection
  • Active autoimmune disease
  • Major surgery within the past 3 months
  • Pregnant or breastfeeding women
  • Severe psychiatric disorder impairing ability to comply with the study protocol

结局指标

主要结局

Time to clinical worsening

时间窗: Up to 36 months

Defined as any of the following: hospitalization for PH, escalation of therapy, 6MWD decrease \>15%, WHO-FC worsening, or death. Measured from baseline.

All-cause mortality

时间窗: Up to 36 months

Death from any cause during follow-up, as confirmed by medical records or death registry.

次要结局

  • Composite risk score performance (AUC)(At baseline and follow-up every 6 months)
  • Changes in NT-proBNP levels(Baseline, 6, 12, 24, 36 months)
  • Hospitalization rate for PH-related causes(Up to 36 months)
  • Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) Measured by Transthoracic Echocardiography(Baseline, 6, 12, 24, 36 months)
  • Change in Right Ventricular Diameter Measured by Transthoracic Echocardiography(Baseline, 6, 12, 24, 36 months)
  • Change in Right Ventricular Fractional Area Change (RVFAC) Measured by Transthoracic Echocardiography(Baseline, 6, 12, 24, 36 months)
  • Change in Right Ventricular Ejection Fraction (RVEF) Measured by Cardiac Magnetic Resonance Imaging(Baseline, 6, 12, 24, 36 months)
  • Change in Right Ventricular End-Diastolic Volume Measured by Cardiac Magnetic Resonance Imaging(Baseline, 6, 12, 24, 36 months)
  • Change in Right Ventricular Mass Measured by Cardiac Magnetic Resonance Imaging(Baseline, 6, 12, 24, 36 months)
  • Change in Right Ventricular FAPI Uptake (SUVmax) Measured by FAPI PET-MR(Baseline, 12, 24, and 36 months)
  • Change in Right Ventricular FAPI Uptake (SUVmean) Measured by FAPI PET-MR(Baseline, 12, 24, and 36 months)
  • Change in Right Ventricular FAPI Uptake Ratio Relative to Left Ventricle (SUVratio) Measured by FAPI PET-MR(Baseline, 12, 24, and 36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dajun Chai

Professor and Chief Physician, Department of Cardiology

First Affiliated Hospital of Fujian Medical University

研究点 (1)

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