Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Starting soon Not applicable

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

NCT07902453 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-11
Last updated
2026-10-28

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Data collection for the development and validation of the cardiovascular virtual human twin

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

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria * Age ≥18 years and ≤ 90 years * Prior diagnosis of HF with LVEF \> 40%, documented by echocardiography performed within the 6 months before screening * Patient already treated with an SGLT2 inhibitor for HF for at least 4 weeks at a stable dose, as part of routine clinical care * With an indication to receive spironolactone for HF, as part of routine clinical care (i.e., not an experimental treatment introduced for the purpose of this study), at the guideline-recommended starting dose, i.e., 25 mg once daily * For patients in sinus rhythm, NT-proBNP levels ≥ 300 pg/ml; for patients in atrial fibrillation, NT-proBNP levels ≥ 600 pg/ml at screening * Affiliated with a social security scheme * Physical condition compatible with the performance of study-related investigations, as judged by the investigator * Patient who has provided written informed consent * Willingness to shave the electrode attachment sites if necessary Exclusion Criteria * Estimated glomerular filtration rate \< 30 mL/min/1.73 m² at screening * Serum potassium \> 5 mmol/l at screening * History of severe hyperkalemia (i.e., ≥ 6 mmol/l) * Hypersensitivity to spironolactone * Treatment with an approved MRA (e.g., spironolactone, eplerenone, finerenone) for more than 7 days within the last month prior to screening * LVEF \< 40% or alternative primary cardiac diagnosis explaining symptoms (significant valvular disease requiring intervention, hypertrophic or infiltrative cardiomyopathy, constrictive pericarditis) * Systolic blood pressure \<100 mmHg or symptomatic hypotension within the previous 24 hours * Systolic blood pressure ≥180 mmHg regardless of treatment, at the time of screening * Acute coronary syndrome, stroke, or transient ischemic attack within the 3 months before screening * Major cardiac surgery, coronary revascularization, or valvular repair within 3 months prior to screening * History of obstructive hypertrophic cardiomyopathy, infiltrative cardiomyopathy (including amyloidosis), restrictive, or arrhythmogenic right ventricular cardiomyopathy * Active myocarditis or pericardial causes of heart failure * History of mechanical circulatory support or heart transplantation * Renal replacement therapy within the previous 4 weeks or requirement for renal replacement therapy * Severe liver disease or Addison's disease * Severe comorbidity with life expectancy \< 1 year * Inability to perform exercise testing (including VO2max), as determined by the physician * Any contraindication to cardiac MRI: severe claustrophobia, any device which is known to threaten or pose hazard in all magnetic resonance environments (as defined on //www.mrisafety.com/, patients with implanted biomedical devices (cardiac artefacts): pacemakers, cardiac defibrillators or cardiac resynchronization therapy * Allergy to gadolinium * Pregnancy or breastfeeding * Individuals suffering from skin irritation or non-intact skin at the sensor attachment sites (sternum, chest, left upper arm, and index, middle or ring finger) * Known allergies to adhesives and/or Ag/AgCl electrodes and/or metals and/or plastic * Receiving medication that is contraindicated to excessive light exposure (in order to exclude the possibility of local skin irritation from irradiation by LED-light of PPG) * Individuals under legal protection or guardianship * Inability to understand the study procedures * Patient under State Medical Aid (AME)

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)

FacilityCityRegionStatus
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
Official registry record

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