An observational study in Heart Failure, Cardiomyopathies and Pulmonary Hypertension, sponsored by Truway Health, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Truway Health, Inc. · Observational
The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state over time. The study will examine cardiac, vascular, pulmonary, and systemic physiologic measurements and develop longitudinal models that describe baseline physiology, physiologic perturbation, compensation, deterioration, treatment response, and recovery. The study is observational and will not assign experimental treatments. The goal is to determine whether changes in multimodal physiologic patterns can be identified and characterized earlier and more reliably than conventional single-time-point assessment.
OMNIPHYS: A Prospective Multimodal Longitudinal Study of AI-Enabled Physiologic State Modeling and Early Detection of Clinical Deterioration
The OMNIPHYS study is a prospective, longitudinal observational investigation designed to develop and evaluate a multimodal framework for characterizing human physiologic state and physiologic trajectory over time. The study is centered on the hypothesis that clinically meaningful deterioration may be preceded by measurable changes across multiple physiologic domains, including cardiac function, vascular flow, pulmonary findings, systemic venous congestion, and other routinely available clinical measurements.
The study will collect and analyze multimodal data obtained during clinically appropriate assessments. Ultrasound-derived data may include two-dimensional and three-dimensional imaging, color Doppler, spectral Doppler, cardiac motion and functional measurements, vascular flow characteristics, venous findings, and pulmonary ultrasound observations. Additional clinical data may include vital signs, electrocardiographic measurements, oxygen saturation, laboratory results, medication and intervention records, diagnoses, encounters, and other relevant longitudinal clinical observations.
The study will develop a Physiologic State Vector (PSV) representing multidimensional observations of an individual at defined points in time. Rather than treating disease status as a binary outcome, OMNIPHYS will investigate physiologic states and transitions between states.
The prespecified conceptual state framework includes:
S0 - Baseline: stable observed physiologic phenotype.
S1 - Physiologic Perturbation: measurable deviation from an individual's established baseline.
S2 - Compensation: persistent physiologic abnormality without defined acute clinical deterioration.
S3 - Pre-Decompensation: a longitudinal trajectory associated with increasing probability of clinically significant deterioration.
S4 - Acute Decompensation: clinically meaningful physiologic or clinical deterioration.
S5 - Intervention Response: measurable physiologic change following clinical intervention.
S6 - Recovery: movement toward the participant's prior or expected physiologic state.
S7 - Persistent Dysfunction: sustained deviation from baseline following an acute event or intervention.
The principal research construct is therefore:
Physiologic State → Longitudinal Trajectory → State Transition → Clinical Outcome
The primary investigational performance measure will be the Physiologic Transition Detection Time (PTDT), defined as the interval between a prospectively defined algorithmic detection of a clinically meaningful physiologic transition and the corresponding predefined clinical reference event. PTDT will be evaluated as a research endpoint and will not independently direct clinical care unless separately authorized under an applicable clinical protocol.
Secondary analyses will evaluate physiologic-state classification, trajectory prediction, treatment-response characterization, recovery prediction, longitudinal model calibration, uncertainty estimation, human-AI concordance, cross-site performance, cross-device robustness, and model stability over time.
The OMNIPHYS framework is intended to support multiple pathology-specific cohorts while maintaining a common physiologic modeling architecture. Potential cohorts may include heart failure, cardiomyopathy, pulmonary hypertension, valvular disease, myocarditis, pericardial disease, pulmonary edema, acute respiratory distress syndrome, pulmonary embolic disease, venous thrombosis, sepsis-associated cardiac dysfunction, systemic venous congestion, acute kidney injury, and other clinically appropriate conditions.
A designated research component will investigate federated learning, in which appropriately governed model-development processes may be evaluated across participating institutions without requiring centralized transfer of patient-level datasets. The study will assess whether multimodal physiologic models maintain performance across institutions, ultrasound platforms, acquisition environments, operators, and heterogeneous clinical populations.
The study may additionally investigate a research construct termed the TRUWAY Physiologic Digital Twin, defined as a computational longitudinal representation of observed physiologic measurements and their temporal relationships. This construct is intended for research into trajectory modeling and prediction and does not represent a clinical diagnosis or autonomous clinical decision-making system.
Data interoperability and research infrastructure may incorporate recognized clinical data representations, including DICOM for medical imaging and FHIR-compatible clinical data structures where available and appropriate. Data provenance, version control, quality assurance, model-version tracking, and longitudinal auditability will be incorporated into the research architecture.
The anticipated study horizon is approximately 20 years, from September 2026 through September 2046, permitting investigation of short-term physiologic transitions as well as long-term disease trajectories, recurrence, recovery, persistent dysfunction, technological evolution, and longitudinal model performance.
OMNIPHYS is designed as an observational research protocol. It does not by itself prescribe medical treatment, alter clinical management, or establish that an investigational algorithm is safe or effective for clinical use. Research findings will be evaluated according to the approved protocol, applicable institutional requirements, human-subject protections, data-governance requirements, and prospective statistical analysis plans.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 25,000 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Truway Health, Inc. is the lead sponsor of 16 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
OMNIPHYS will enroll a diverse adult population including healthy volunteers and participants receiving routine clinical evaluation or care. The study will include individuals across cardiovascular, vascular, pulmonary, renal, and systemic physiologic conditions, with disease-specific and physiologic subcohorts analyzed within a common longitudinal framework. Multimodal ultrasound, Doppler, physiologic measurements, clinical data, laboratory data, and longitudinal outcomes will be evaluated to characterize individual physiologic states, trajectories, transitions, treatment responses, and recovery patterns.
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.
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.
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.
A prospective longitudinal observational cohort of participants undergoing routine clinical evaluation and/or care. The cohort will be characterized using multimodal physiologic observations, including ultrasound-derived imaging, 2D and 3D imaging, color and spectral Doppler, cardiac and vascular measurements, pulmonary ultrasound findings, vital signs, ECG, oxygen saturation, laboratory data, medications, diagnoses, clinical encounters, and longitudinal outcomes. Participants will not be assigned to an experimental treatment. Disease-specific and physiologic subcohorts may be evaluated within the master cohort using a common longitudinal physiologic-state framework.
Device: OMNIPHYS Multimodal Ultrasound Imaging System
Observational physiologic and imaging data acquisition.
Physiologic Transition Detection Time (PTDT)
Time interval, measured in days, between the first prespecified algorithmic detection of a clinically meaningful physiologic state transition and the corresponding predefined clinical reference event. Transitions may include progression from baseline or compensated physiology to pre-decompensation or acute decompensation. The analysis will evaluate the temporal relationship between multimodal physiologic signals and subsequent clinical events.
Time frame: Continuous longitudinal assessment from baseline (Year 0) through Year 50; PTDT will be calculated separately for each predefined clinical reference event occurring during the 50-year follow-up period.
Physiologic State Classification Accuracy
Accuracy of classification of predefined longitudinal physiologic states (S0 Baseline, S1 Physiologic Perturbation, S2 Compensation, S3 Pre-Decompensation, S4 Acute Decompensation, S5 Intervention Response, S6 Recovery, and S7 Persistent Dysfunction) using multimodal clinical, physiologic, and ultrasound-derived data.
Time frame: Baseline (Year 0) through Year 50; physiologic state-classification accuracy will be assessed using all evaluable longitudinal observations and predefined clinical reference events collected during the 50-year follow-up period.
Physiologic Trajectory Prediction
Performance of longitudinal models in predicting subsequent physiologic state transitions and clinically meaningful deterioration from prior multimodal physiologic observations.
Time frame: Baseline (Year 0) through Year 50 of longitudinal follow-up.
Time to Clinical Deterioration
Time from enrollment or a predefined physiologic assessment to the occurrence of a prespecified clinically meaningful deterioration event, evaluated in relation to longitudinal multimodal physiologic trajectories.
Time frame: Baseline (Year 0) through Year 50 of longitudinal follow-up.
Treatment Response Characterization
Association between observed clinical interventions and subsequent changes in multimodal physiologic state, including quantitative characterization of physiologic response, non-response, delayed response, and recurrence.
Time frame: Baseline (Year 0) through Year 50 of longitudinal follow-up.
Physiologic Recovery Trajectory
Magnitude and rate of movement from an abnormal or decompensated physiologic state toward a predefined recovery state following a clinical event or intervention.
Time frame: Baseline (Year 0) through Year 50 of longitudinal follow-up.
Multimodal AI Discrimination Performance
Discrimination, calibration, sensitivity, specificity, and predictive performance of multimodal artificial-intelligence models for identifying predefined physiologic states and clinically meaningful state transitions.
Time frame: Baseline (Year 0) through Year 50 of longitudinal follow-up.
Cross-Site and Cross-Device Generalizability
Performance consistency of physiologic-state models across participating clinical sites, ultrasound systems, transducer configurations, acquisition protocols, patient populations, and other relevant data domains.
Time frame: Baseline (Year 0) through Year 50 of longitudinal follow-up.
Model Drift and Temporal Stability
Longitudinal assessment of changes in model performance, calibration, data distributions, and physiologic feature distributions over time to characterize temporal robustness and potential model drift.
Time frame: Baseline (Year 0) through Year 50 of longitudinal follow-up.
Human-AI Concordance
Agreement between AI-derived physiologic-state classifications and qualified human clinical or imaging assessments using prespecified agreement and concordance measures.
Time frame: Baseline (Year 0) through Year 50 of longitudinal follow-up.
Plan to share: Yes — Individual participant data (IPD) will be made available to qualified researchers for scientifically valid, methodologically sound secondary research following completion of the primary study analyses and publication of the principal results, subject to applicable ethical, regulatory, privacy, informed-consent, and data-use requirements. De-identified participant-level datasets and accompanying data dictionaries may be shared through a controlled-access process. Requests will be evaluated by the study's designated data-access/governance body based on scientific merit, methodological rigor, feasibility, participant privacy protections, and consistency with the informed consent and applicable institutional requirements. Direct identifiers will not be shared. Data will undergo appropriate de-identification and disclosure-risk assessment before release. Access may require a data-use agreement specifying permitted purposes, security requirements, prohibition of re-identification, restrict
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Beginning after publication of the primary results and continuing for as long as scientifically and ethically appropriate.
Access criteria: Qualified researchers submitting scientifically valid proposals through the designated study data-access process.
Started Sep 2026 (actual). Primary completion is estimated for Sep 2046, 240 months after the start.
Of 182 industry-sponsored observational studies under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's planned 240 months is above that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
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