Trial · NCT07902453
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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). |
| Secondary | Change in KCCQ-12 score | Baseline to 3 months. | Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score (points). |
| Secondary | Change in NT-proBNP | Baseline to 3 months. | Change in NT-proBNP concentration (pg/mL). |
| Secondary | Change in estimated glomerular filtration rate | Baseline to 3 months. | Change in estimated glomerular filtration rate (mL/min/1.73 m²). |
| Secondary | Change in serum potassium | Baseline to 3 months | Change in serum potassium concentration (mmol/L). |
| Secondary | Spironolactone pharmacokinetic parameter | Baseline to 3 months. | Spironolactone pharmacokinetic parameter. |
| Secondary | Change in echocardiographic parameter | Baseline to 3 months. | Change in echocardiographic measurements between baseline and follow-up. |
| Secondary | Change in cardiac magnetic resonance imaging parameter | Baseline to 3 months | Change in cardiac magnetic resonance imaging measurements between baseline and follow-up. |
| Secondary | Change in vascular parameter | Baseline to 3 months | Change in central pulse wave velocity between baseline and follow-up. |
| Secondary | Change in autonomic function parameter | Baseline to 3 months | Change in cardiovascular responses during cold-pressor and hand-grip testing. |
| Secondary | Change in perception of artificial intelligence | Baseline to 3 months | Dedicated questionnaire |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT07902453/registered