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NCT06739057 · ClinicalTrials.gov registry record
Pediatric Ventricle Function Assessment Study
A clinical trial of Pulmonary Hypertension and LV Dysfunction, sponsored by HBI Solutions.
- Completed
- Registry status
- 3,993
- Enrollment target
- 1
- Study location
NCT06739057: Completed study of Pulmonary Hypertension and LV Dysfunction, sponsored by HBI Solutions.
NCT06739057 is a study of Pulmonary Hypertension and LV Dysfunction that has completed, run by HBI Solutions. The registered enrollment target is 3,993 participants, above the 558-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (616% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06739057, a study of Pulmonary Hypertension and LV Dysfunction, has completed, sponsored by HBI Solutions.
- COMPLETED
- Registry status
- 3,993 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to develop a deep learning-based framework for right ventricular (RV) segmentation, prediction of RV fractional area change (FAC), and identification of pediatric RV dysfunction. The AI model was designed to distinguish between normal pediatric hearts, pulmonary hypertension (PH), and Tetralogy of Fallot (TOF). To improve diagnostic accuracy, the investigators extended the analysis beyond the A4C view by integrating data from both A4C and PSAX views. Additionally, the framework was applied to predict left ventricular ejection fraction (LV EF), further showcasing its versatility and clinical utility.
Primary Outcome
FAC \< 35% is considered RV abnormal. The automated extracted FAC values were then used to predict the probability of abnormal RV function.FAC estimation accuracy was evaluated using mean absolute error (MAE), root mean squared error (RMSE), and Pearson correlation coefficient (R). Diagnostic performance metrics included AUC, sensitivity, and specificity for RV function assessment
Conditions Studied
Study Locations (1)
California
- Stanford University - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,993 participants |
| Start Date | 2014-01-01 |
| Est. Completion | 2024-08-31 |
What the finished NCT06739057 record still lists
NCT06739057 is an observational study that tracks outcomes without assigning an intervention. Its 3,993 participants enrollment target places it among the larger protocols in the corpus, above the 558-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (616% higher).
The record links to 4 conditions, with Pulmonary Hypertension appearing as the primary indexed condition, and to 0 interventions.
NCT06739057 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06739057 about?
NCT06739057 is a clinical study titled "Pediatric Ventricle Function Assessment Study". This study aims to develop a deep learning-based framework for right ventricular (RV) segmentation, prediction of RV fractional area change (FAC), and identification of pediatric RV dysfunction. The AI model was designed to distinguish between normal pediatric hearts, pulmonary hypertension (PH), an...
What is the current status of trial NCT06739057?
This trial is currently completed. The enrollment target is 3,993 participants. The study started on 2014-01-01. Estimated completion is 2024-08-31.
What conditions does trial NCT06739057 study?
This clinical trial studies the following conditions: Pulmonary Hypertension, LV Dysfunction, RV - Right Ventricular Abnormality, TOF.
Who is sponsoring clinical trial NCT06739057?
This trial is sponsored by HBI Solutions, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06739057 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06739057's enrollment target sits among peer trials
3,993 4th of 72 higher than 69 of 72 other Pulmonary Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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