Heart FailureVITAL-HFNCT07902453
Virtual Human Twins as Tools for Personalized Clinical Care in Heart Failure With Preserved Ejection Fraction: a Pilot Study
A study testing Data collection for the development and validation of the cardiovascular virtual human twin in people with Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Data collection for the development and validation of the cardiovascular virtual human twin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Cardiologie - Hôpital Européen Georges Pompidou - AP-HP
Paris, Île-de-France Region, 75015
Albert Alain Hagege, 0033156093713, albert.hagege@aphp.fr
Centre d'investigation Clinique - Hôpital Européen Georges Pompidou - AP-HP
Paris, Île-de-France Region, 75
Jean Sébastien Hulot, 0033156092912, jean-sebastien.hulot@aphp.fr
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Data collection for the development and validation of the cardiovascular virtual human twin
- Keywords
- Heart Failure, Virtual Human Twin, Artificial Intelligence, Precision Medicine, Multimodal Phenotyping, Treatment Response, Spironolactone, Mineralocorticoid Receptor Antagonist
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection for the development and validation of the cardiovascular virtual human twinOther
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 group | Role | What they receive |
|---|---|---|
| Patients with heart failure initiating spironolactone | Other | 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. Receives: Other: Data collection for the development and validation of the cardiovascular virtual human twin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months after spironolactone initiation.
Secondary outcomes (19)
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.
Measured: 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.
Measured: 3 months after spironolactone initiation
Overall survival
All-cause mortality.
Measured: 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.
Measured: From spironolactone initiation through 3 months.
Change in congestion status
Change in bioimpedance-derived congestion parameters (extracellular-to-total body water ratio).
Measured: Baseline to 3 months.
Change in maximal oxygen uptake
Change in maximal oxygen uptake (VO₂max) measured during cardiopulmonary exercise testing.
Measured: Baseline to 3 months.
Change in systolic blood pressure
Change in systolic blood pressure (mmHg).
Measured: Baseline to 3 months.
Change in NYHA functional class
Change in New York Heart Association (NYHA) functional class.
Measured: Baseline to 3 months.
Change in 6-minute walking distance
Change in 6-minute walking distance (meters).
Measured: Baseline to 3 months.
Change in KCCQ-12 score
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score (points).
Measured: Baseline to 3 months.
Change in NT-proBNP
Change in NT-proBNP concentration (pg/mL).
Measured: Baseline to 3 months.
Change in estimated glomerular filtration rate
Change in estimated glomerular filtration rate (mL/min/1.73 m²).
Measured: Baseline to 3 months.
Change in serum potassium
Change in serum potassium concentration (mmol/L).
Measured: Baseline to 3 months
Spironolactone pharmacokinetic parameter
Spironolactone pharmacokinetic parameter.
Measured: Baseline to 3 months.
Change in echocardiographic parameter
Change in echocardiographic measurements between baseline and follow-up.
Measured: Baseline to 3 months.
Change in cardiac magnetic resonance imaging parameter
Change in cardiac magnetic resonance imaging measurements between baseline and follow-up.
Measured: Baseline to 3 months
Change in vascular parameter
Change in central pulse wave velocity between baseline and follow-up.
Measured: Baseline to 3 months
Change in autonomic function parameter
Change in cardiovascular responses during cold-pressor and hand-grip testing.
Measured: Baseline to 3 months
Change in perception of artificial intelligence
Dedicated questionnaire
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ghent, Belgium, University of Auckland, New Zealand, University of Maastricht, Netherlands, University of Delft, Netherlands, University of Pisa, Jagielloński University, Poland, Austrian Institute of Technology, Austria, IMEC, Netherlands, ELEM Biotech, Spain, WCR, Netherlands, École Polytechnique Fédérale de Lausanne, Switzerland, Kings College London, UK, University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Jean Sébastien Hulot, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902453
- Sponsor's protocol ID
- APHP260534
- Acronym
- VITAL-HF
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Human Twins as Tools for Personalized Clinical Care in Heart Failure With Preserved Ejection Fraction: a Pilot Study
- ClinicalTrials.gov ID
- NCT07902453
- Acronym / sponsor ID
- VITAL-HF / APHP260534
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Virtual Human Twin, Artificial Intelligence, Precision Medicine, Multimodal Phenotyping, Treatment Response, Spironolactone, Mineralocorticoid Receptor Antagonist
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- University of Ghent, Belgium, University of Auckland, New Zealand, University of Maastricht, Netherlands, University of Delft, Netherlands, University of Pisa, Jagielloński University, Poland, Austrian Institute of Technology, Austria, IMEC, Netherlands, ELEM Biotech, Spain, WCR, Netherlands, École Polytechnique Fédérale de Lausanne, Switzerland, Kings College London, UK, University College London Hospitals
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with heart failure initiating spironolactone | Other | Other: Data collection for the development and validation of the cardiovascular virtual human twinAdult 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection for the development and validation of the cardiovascular virtual human twinMultimodal 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. | Other | Patients with heart failure initiating spironolactone |
Primary outcome
Discriminative performance of the VITAL cardiovascular virtual human twin for predicting response to spironolactone
Time frame: 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.
19 secondary outcomes
Prediction of spironolactone-associated adverse events
Time frame: From spironolactone initiation through 3 months.
Calibration of the VITAL cardiovascular virtual human twin
Time frame: 3 months after spironolactone initiation
Overall survival
Time frame: From spironolactone initiation through 3 months.
Major adverse cardiovascular events
Time frame: From spironolactone initiation through 3 months.
Change in congestion status
Time frame: Baseline to 3 months.
Change in maximal oxygen uptake
Time frame: Baseline to 3 months.
Change in systolic blood pressure
Time frame: Baseline to 3 months.
Change in NYHA functional class
Time frame: Baseline to 3 months.
Change in 6-minute walking distance
Time frame: Baseline to 3 months.
Change in KCCQ-12 score
Time frame: Baseline to 3 months.
Change in NT-proBNP
Time frame: Baseline to 3 months.
Change in estimated glomerular filtration rate
Time frame: Baseline to 3 months.
Change in serum potassium
Time frame: Baseline to 3 months
Spironolactone pharmacokinetic parameter
Time frame: Baseline to 3 months.
Change in echocardiographic parameter
Time frame: Baseline to 3 months.
Change in cardiac magnetic resonance imaging parameter
Time frame: Baseline to 3 months
Change in vascular parameter
Time frame: Baseline to 3 months
Change in autonomic function parameter
Time frame: Baseline to 3 months
Change in perception of artificial intelligence
Time frame: Baseline to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Sébastien Hulot principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data collection for the development and validation of the cardiovascular virtual human twin in people with Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghizlène Tabet Derraz (0033140273790, ghizlen.tabet-derraz@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discriminative performance of the VITAL cardiovascular virtual human twin for predicting response to spironolactone (time frame: Baseline to 3 months after spironolactone initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.