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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Fujian Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older

Pulmonary artery systolic pressure (PASP) ≥35 mmHg as estimated by echocardiography

Provided written informed consent

Disqualifiers

Severe hepatic or renal insufficiency

Malignancy under active treatment

Severe infection

Active autoimmune disease

Trial population

The study population includes adult patients (≥18 years) undergoing transthoracic echocardiography. Participants with a pulmonary artery systolic pressure (PASP) ≥35 mmHg on echocardiography will be included as suspected pulmonary hypertension cases. This cohort represents a real-world population at risk for or with early-stage pulmonary hypertension, suitable for developing dynamic risk prediction models based on multimodal data integration.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Suspected PH by Echocardiography

Trial outcomes

Primary outcomes

1

Time to clinical worsening

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

Time frame
Up to 36 months
2

All-cause mortality

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

Time frame
Up to 36 months

Secondary outcomes

1

Composite risk score performance (AUC)

Area under the ROC curve for the multimodal model predicting adverse outcomes.

Time frame
At baseline and follow-up every 6 months
2

Changes in NT-proBNP levels

Evaluate biomarker dynamics and predictive value.

Time frame
Baseline, 6, 12, 24, 36 months
3

Hospitalization rate for PH-related causes

Frequency of hospital admissions due to PH complications.

Time frame
Up to 36 months
4

Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) Measured by Transthoracic Echocardiography

TAPSE (mm) will be measured via transthoracic echocardiography to evaluate longitudinal right ventricular systolic function over time.

Time frame
Baseline, 6, 12, 24, 36 months

Other outcomes

1

Longitudinal changes in health-related quality of life (HRQoL) among patients with suspected or confirmed pulmonary hypertension

Health-related quality of life (HRQoL) will be assessed using validated instruments such as the EQ-5D-3L and/or the emPHasis-10 questionnaire, both commonly used in pulmonary hypertension research. The emPHasis-10 is a disease-specific, patient-reported outcome measure developed for individuals with pulmonary hypertension, covering domains such as breathlessness, fatigue, social limitation, and psychological burden. Changes in HRQoL scores will be evaluated over time and correlated with clinical events (e.g., hospitalization, WHO functional class deterioration), imaging parameters (e.g., RV function), biomarkers (e.g., NT-proBNP), and model-predicted risk strata. Analyses will include repeated measures ANOVA or mixed-effects modeling to examine within-subject longitudinal chan

Time frame
Baseline, 6, 12, 24, and 36 months
2

Area Under the ROC Curve (AUC) of the Multimodal Risk Prediction Model

The area under the receiver operating characteristic curve (AUC) will be calculated to evaluate the discrimination performance of the multimodal dynamic risk prediction model for adverse outcomes.

Time frame
Baseline, 12, 24, 36 months
3

Harrell's Concordance Index (C-index) of the Multimodal Risk Prediction Model

The concordance index (C-index) will be computed to assess the predictive accuracy of the multimodal risk prediction model.

Time frame
Baseline, 12, 24, 36 months
4

Calibration Slope of the Multimodal Risk Prediction Model

Calibration slope will be estimated to measure agreement between predicted and observed risks in the dynamic risk prediction model.

Time frame
Baseline, 12, 24, 36 months

Sponsors and contacts

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