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Life sciences · Interventional Study
ClinicalTrials.gov · October 28, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07902453). This is a study registration, not published results. Lead sponsor: Assistance Publique - Hôpitaux de Paris. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Heart Failure. Interventions: OTHER: Data collection for the development and validation of the cardiovascular virtual human twin. Primary outcome measures: Discriminative performance of the VITAL cardiovascular virtual human twin for predicting response to spironolactone , Baseline to 3 months after spironolactone initiation.. Brief 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.