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NOT YET RECRUITING
NCT07902453
NA

Virtual Human Twins as Tools for Personalized Clinical Care in Heart Failure With Preserved Ejection Fraction: a Pilot Study

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-11

Completion Date

2029-02

Last Updated

2026-10-28

Healthy Volunteers

No

Conditions

Interventions

OTHER

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.

Locations (2)

Cardiologie - Hôpital Européen Georges Pompidou - AP-HP

Paris, Île-de-France Region, France

Centre d'investigation Clinique - Hôpital Européen Georges Pompidou - AP-HP

Paris, Île-de-France Region, France