PH-DyPred: A Multimodal Dynamic Risk Prediction Study in Pulmonary Hypertension

Recruiting

• Conditions: Pulmonary Hypertension

• Registration Number: NCT07131241
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-27
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-17
• Last Update Submitted: 2025-08-17
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Primary Completion: 2028-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to clinical worsening	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	Up to 36 months	Death from any cause during follow-up, as confirmed by medical records or death registry.

Secondary Outcome Measures

Name	Time	Method
Composite risk score performance (AUC)	At baseline and follow-up every 6 months	Area under the ROC curve for the multimodal model predicting adverse outcomes.
Changes in NT-proBNP levels	Baseline, 6, 12, 24, 36 months	Evaluate biomarker dynamics and predictive value.
Hospitalization rate for PH-related causes	Up to 36 months	Frequency of hospital admissions due to PH complications.
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) Measured by Transthoracic Echocardiography	Baseline, 6, 12, 24, 36 months	TAPSE (mm) will be measured via transthoracic echocardiography to evaluate longitudinal right ventricular systolic function over time.
Change in Right Ventricular Diameter Measured by Transthoracic Echocardiography	Baseline, 6, 12, 24, 36 months	Right ventricular internal diameter (mm) will be assessed by echocardiography as an indicator of RV structural remodeling.
Change in Right Ventricular Fractional Area Change (RVFAC) Measured by Transthoracic Echocardiography	Baseline, 6, 12, 24, 36 months	RVFAC (%) will be calculated as the percentage change in RV area between end-diastole and end-systole to assess systolic function.
Change in Right Ventricular Ejection Fraction (RVEF) Measured by Cardiac Magnetic Resonance Imaging	Baseline, 6, 12, 24, 36 months	RVEF (%) will be quantified using cardiac magnetic resonance imaging to evaluate global systolic function.
Change in Right Ventricular End-Diastolic Volume Measured by Cardiac Magnetic Resonance Imaging	Baseline, 6, 12, 24, 36 months	Right ventricular end-diastolic volume (mL) will be measured by CMR to assess structural remodeling over time.
Change in Right Ventricular Mass Measured by Cardiac Magnetic Resonance Imaging	Baseline, 6, 12, 24, 36 months	Right ventricular mass (grams) will be measured by CMR as an index of ventricular hypertrophy and remodeling.
Change in Right Ventricular FAPI Uptake (SUVmax) Measured by FAPI PET-MR	Baseline, 12, 24, and 36 months	Maximum standardized uptake value (SUVmax) of FAPI in the right ventricle will be measured via PET-MR as an indicator of peak regional fibroblast activation.
Change in Right Ventricular FAPI Uptake (SUVmean) Measured by FAPI PET-MR	Baseline, 12, 24, and 36 months	tandardized uptake value mean (SUVmean) of FAPI in the right ventricular free wall will be quantified using PET-MR imaging to assess fibroblast activation and myocardial fibrotic activity over time in patients with pulmonary hypertension.
Change in Right Ventricular FAPI Uptake Ratio Relative to Left Ventricle (SUVratio) Measured by FAPI PET-MR	Baseline, 12, 24, and 36 months	The ratio of right ventricular to left ventricular myocardial FAPI uptake (SUVmean RV/SUVmean LV) will be calculated as a normalized index of right ventricular fibrotic remodeling.

Trial Locations

Locations (1)

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China