Virtual Human Twins as Tools for Personalized Clinical Care in Heart Failure With Preserved Ejection Fraction: a Pilot Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Data collection for the development and validation of the cardiovascular virtual human twin: Multimodal clinical, biological, imaging, functional and patient-reported data will be collected to develop cardiovascular virtual human twins in patients with HFpEF. Data will include clinical characteristics, ECG, laboratory tests, echocardiography, CPET, bioimpedance, 6-minute walking distance, vascular and autonomic assessments. Additional research data will include cardiac MRI with gadolinium, CALAMARI recordings (ECG, SCG, PPG), spironolactone pharmacokinetic blood and urine samples, and blood samples for proteomic and metabolomic analyses. Questionnaires will assess quality of life, psychological factors, AI perceptions, trust and digital literacy. The collected data will be integrated to generate patient-specific virtual twins and assess their ability to predict individual response to spironolactone. Predictions will not influence clinical management.
Study summary
Heart failure (HF) is a heterogeneous clinical syndrome characterized by substantial inter-individual variability in pathophysiology and response to treatment. Precision medicine approaches are therefore needed to better account for this heterogeneity and tailor therapeutic strategies to individual patients. Virtual human twins represent one such approach, integrating multimodal clinical, biological, imaging, physiological, and omics data into patient-specific computational models to model disease mechanisms and predict individual therapeutic response.
VITAL-HF is a prospective cohort pilot study designed to clinically evaluate the ability of the VITAL cardiovascular virtual human twin to predict individual response to spironolactone in patients with HF. Adult patients with HF with left ventricular ejection fraction (LVEF) \> 40% who have a clinical indication for spironolactone as part of routine care will be enrolled and followed for 3 months. The primary objective is to assess the ability of the VITAL cardiovascular virtual human twin to discriminate responders from non-responders to spironolactone. Response is defined as a ≥20% reduction in NT-proBNP levels 3 months after spironolactone initiation.
Virtual twin predictions will be generated for research purposes only and will not influence treatment decisions or patient management.
Eligibility
Primary outcome measure(s)
- Discriminative performance of the VITAL cardiovascular virtual human twin for predicting response to spironolactone — Baseline to 3 months after spironolactone initiation.
The discriminative ability of the VITAL cardiovascular virtual human twin to identify responders versus non-responders to spironolactone will be assessed using the area under the receiver operating characteristic curve (AUROC). A responder is defined as a participant with a ≥20% reduction in NT-proBNP from baseline to 3 months after spironolactone initiation.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Cardiologie - Hôpital Européen Georges Pompidou - AP-HP | Paris | Île-de-France Region | |
| Centre d'investigation Clinique - Hôpital Européen Georges Pompidou - AP-HP | Paris | Île-de-France Region |
More Assistance Publique - Hôpitaux de Paris trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07902453 on ClinicalTrials.gov ↗ ← All trials in France