Trial · NCT07902453
Virtual Human Twins as Tools for Personalized Clinical Care in Heart Failure With Preserved Ejection Fraction: a Pilot Study
NCT07902453, Not applicable, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Virtual Human Twins as Tools for Personalized Clinical Care in Heart Failure With Preserved Ejection Fraction: a Pilot Study. Trials, record NCT07902453. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07902453
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Virtual Human Twins as Tools for Personalized Clinical Care in Heart Failure With Preserved Ejection Fraction: a Pilot Study
- NCT number
- NCT07902453
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Heart Failure
- Interventions
- Data collection for the development and validation of the cardiovascular virtual human twin
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Prediction of spironolactone-associated adverse events | From spironolactone initiation through 3 months. | 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. |
| Secondary | Calibration of the VITAL cardiovascular virtual human twin | 3 months after spironolactone initiation | Calibration of predicted versus observed response to spironolactone, assessed using calibration intercept, calibration slope, and calibration plots. |
| Secondary | Overall survival | From spironolactone initiation through 3 months. | All-cause mortality. |
| Secondary | Major adverse cardiovascular events | From spironolactone initiation through 3 months. | Occurrence of major adverse cardiovascular events, including cardiovascular death, hospitalization for heart failure, non-fatal myocardial infarction, and non-fatal stroke. |
| Secondary | Change in congestion status | Baseline to 3 months. | Change in bioimpedance-derived congestion parameters (extracellular-to-total body water ratio). |
| Secondary | Change in maximal oxygen uptake | Baseline to 3 months. | Change in maximal oxygen uptake (VO₂max) measured during cardiopulmonary exercise testing. |
| Secondary | Change in systolic blood pressure | Baseline to 3 months. | Change in systolic blood pressure (mmHg). |
| Secondary | Change in NYHA functional class | Baseline to 3 months. | Change in New York Heart Association (NYHA) functional class. |
| Secondary | Change in 6-minute walking distance | Baseline to 3 months. | Change in 6-minute walking distance (meters). |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07902453
GET https://conductscience.org/api/trials/v1/NCT07902453/registered