An interventional study of Data collection for the development and validation of the cardiovascular virtual human twin in Heart Failure, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 60 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with heart failure with LVEF \> 40% who have a clinical indication to initiate spironolactone as part of routine clinical care. Participants undergo multimodal phenotyping at baseline and at 3 months. Cardiovascular virtual human twin predictions are generated for research purposes only and do not influence clinical management.
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.
Discriminative performance of the VITAL cardiovascular virtual human twin for predicting response to spironolactone
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.
Time frame: Baseline to 3 months after spironolactone initiation.
Prediction of spironolactone-associated adverse events
Ability of the VITAL cardiovascular virtual human twin to predict spironolactone-associated safety events, defined by the aggregation of the following events : hyperkalemia (serum potassium \>5.5 mmol/L and \>6.0 mmol/L), worsening renal function (including ≥30% decrease in eGFR or significant increase in serum creatinine), symptomatic hypotension or systolic blood pressure \<90 mmHg, and treatment discontinuation due to adverse events.
Time frame: From spironolactone initiation through 3 months.
Calibration of the VITAL cardiovascular virtual human twin
Calibration of predicted versus observed response to spironolactone, assessed using calibration intercept, calibration slope, and calibration plots.
Time frame: 3 months after spironolactone initiation
Overall survival
All-cause mortality.
Time frame: From spironolactone initiation through 3 months.
Major adverse cardiovascular events
Occurrence of major adverse cardiovascular events, including cardiovascular death, hospitalization for heart failure, non-fatal myocardial infarction, and non-fatal stroke.
Time frame: From spironolactone initiation through 3 months.
Change in congestion status
Change in bioimpedance-derived congestion parameters (extracellular-to-total body water ratio).
Time frame: Baseline to 3 months.
Change in maximal oxygen uptake
Change in maximal oxygen uptake (VO₂max) measured during cardiopulmonary exercise testing.
Time frame: Baseline to 3 months.
Change in systolic blood pressure
Change in systolic blood pressure (mmHg).
Time frame: Baseline to 3 months.
Change in NYHA functional class
Change in New York Heart Association (NYHA) functional class.
Time frame: Baseline to 3 months.
Change in 6-minute walking distance
Change in 6-minute walking distance (meters).
Time frame: Baseline to 3 months.
Change in KCCQ-12 score
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score (points).
Time frame: Baseline to 3 months.
Change in NT-proBNP
Change in NT-proBNP concentration (pg/mL).
Time frame: Baseline to 3 months.
Change in estimated glomerular filtration rate
Change in estimated glomerular filtration rate (mL/min/1.73 m²).
Time frame: Baseline to 3 months.
Change in serum potassium
Change in serum potassium concentration (mmol/L).
Time frame: Baseline to 3 months
Spironolactone pharmacokinetic parameter
Spironolactone pharmacokinetic parameter.
Time frame: Baseline to 3 months.
Change in echocardiographic parameter
Change in echocardiographic measurements between baseline and follow-up.
Time frame: Baseline to 3 months.
Change in cardiac magnetic resonance imaging parameter
Change in cardiac magnetic resonance imaging measurements between baseline and follow-up.
Time frame: Baseline to 3 months
Change in vascular parameter
Change in central pulse wave velocity between baseline and follow-up.
Time frame: Baseline to 3 months
Change in autonomic function parameter
Change in cardiovascular responses during cold-pressor and hand-grip testing.
Time frame: Baseline to 3 months
Change in perception of artificial intelligence
Dedicated questionnaire
Time frame: Baseline to 3 months
Plan to share: Yes — Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned meta-analysis could be shared
Supporting information: Study protocol, Informed consent form
Time frame: Two years after the last publication
Access criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The funder could be involved in the decision. Teams wishing to obtain IPD must meet the sponsor and PI team to present scientific (and commercial) purposes, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Feb 2029, 27 months later.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 27 months is close to that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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