Developing a Non-invasive Cardiac Functional Health Status Measurement Device: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Developing a Non-invasive Cardiac Functional Health Status Measurement Device (NCT01877343), a na na study. The primary outcome is Pulse Rate.

2. Clinical Question

The central question is about measurement and discrimination, rather than a comparison of treatments. The planned assessment was to track pulse rate as participants moved through positions intended to alter circulatory loading. The record names mounting position, baseline, passive leg raise, and orthostasis head raise. Passive leg raise is described as cardiac-preload-dependent, while orthostasis head raise is described as cardiac-afterload-dependent. Participants were to move from mounting position to baseline, then to the corresponding position and back to baseline.

The study description says these physiological measurements would be compared with functional classifications defined by NYHA criteria for adults and the NYPHF index for pediatric participants. It does not report a completed comparison, a measure of discriminatory performance, or the relationship between pulse-rate patterns and either classification. The study was terminated, and the planned analysis was not completed. Therefore, the registry record identifies the question the investigators intended to investigate, but does not establish whether the measurement approach separated functional categories in the enrolled population.

3. Trial Design

This was a single-center, non-randomized, single-group study sponsored by the University of Florida. The registry lists an enrollment of 10 and describes the intervention as the CVInsight(TM) device. There was no random allocation and no separate control arm. The study record identifies its status as terminated, with a start date of 2013-06 and a primary completion date of 2015-01.

The planned procedure involved placing participants on a tilt table and collecting pulse-oximeter and blood-pressure measurements at different table positions. The intervention description says that a hemodynamic monitor called CVInsight(TM) would monitor pulse-oximeter readings. The study summary describes a stress test across four positions, while the primary outcome description specifies mounting position, baseline, passive leg raise, and orthostasis head raise. The stated sequence moves participants from mounting position to baseline, then to the corresponding position—passive leg raise or orthostasis head raise—and back to baseline. The record does not clarify whether every participant was assessed in both of those corresponding positions.

The primary outcome was average pulse rate from baseline to 30 minutes. Continuous changes in pulse rate were to be followed and plotted against tilt-table position, with an average calculated from the graph. Although the registry lists two outcome measures, it reports zero analyses. It also states that the study was terminated and that data were not sent to the contract company for analysis because the University of Florida did not have the software package needed to compile the data.

The registry record does not report a randomization procedure, a masking procedure beyond listing masking as none, a formal sample-size justification, or a statistical analysis plan. It does not describe a control comparison, and the design should not be interpreted as one. The record also does not state how many enrolled participants completed the planned measurements or contributed data to the primary outcome.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Patients recruited only from two of the study groups (control and post-transplant). Patients from the other groups were not included as study team assessed feasibility with the non-heart failure groups prior to consenting high failure patients. Enrollment was challenging for high risk patients due to stress test severity.

Only the first 6 of 7 groups are shown.

Overall Study

Analysis population for the primary outcome, as defined in the registry: The study was terminated and the data was not sent to the contract company to analyze. The software package to compile the data is not available to the University of Florida.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Pulse Rate, measured over Average pulse rate from baseline to 30 minutes.

The primary endpoint is average pulse rate from baseline to 30 minutes. The planned measurement was continuous change in pulse rate over the study assessment, considered in relation to changes in tilt-table position. The positions were intended to represent different circulatory loading conditions: passive leg raise is described as cardiac-preload-dependent, and orthostasis head raise as cardiac-afterload-dependent. Blood pressure was also to be measured, while pulse oximetry posted the pulse-rate and pulse-strength readings monitored by CVInsight(TM).

The endpoint is relevant to the study’s stated measurement aim because the investigators wanted to assess whether cardiac functional health status could be distinguished by the degree to which cardiac function depended on changes in preload and afterload. The planned comparison was with functional classifications based on NYHA criteria for adults and the NYPHF index for pediatric participants. In general, a continuous measure can describe how a physiological signal changes over an assessment, rather than reducing it to a single category. That feature could be useful in examining whether patterns differ across clinical classifications, but such a comparison requires analyzed measurements and an appropriate method for assessing discrimination.

The registry record does not report an observed average pulse rate, an estimate of change, variability, a confidence interval, or a completed comparison with either classification system. It says that the data were not analyzed. Consequently, the endpoint’s definition and rationale are available, but its observed behavior and its discriminatory value are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study planned to measure a continuous physiological variable—pulse rate—over an assessment lasting 30 minutes. The description says pulse rate would be followed from baseline through the end of the study, plotted against tilt-table positions, and averaged from the graph. This gives a general outline of the measurement process, but it does not specify the statistical model or estimation procedure used to turn repeated measurements into an outcome estimate. The registry record says that the data were not analyzed.

What a continuous endpoint can show

In general, a continuous endpoint retains the scale of a measurement rather than classifying each observation as simply present or absent. Repeated pulse-rate measurements could describe the pattern of change during position shifts, while a mean or average could provide a compact summary. A summary can be easier to interpret, but it may conceal variation over time or differences in patterns between participants. The record describes an average calculated from a graph; it does not report whether the planned analysis would also retain or compare the full time course.

Repeated observations from the same participant are related, rather than independent measurements from unrelated people. In general, an analysis of repeated measures needs to account for that within-participant relationship if it estimates an overall response or compares positions. The registry record does not report a repeated-measures model, a covariance structure, a method for handling irregular measurement times, or a model for participant-level differences. No specific analysis should be attributed to the investigators beyond the described plan to follow, plot, and average pulse rate.

Position changes and interpretation

The planned positions were intended to probe changes in circulatory loading. The study description labels passive leg raise as cardiac-preload-dependent and orthostasis head raise as cardiac-afterload-dependent. In general, comparing measurements under changing physiological conditions can help characterize a response to those conditions, but observed changes alone do not establish that a measure correctly classifies health status. To assess discrimination, an analysis would need to compare the measurement or its pattern with the referenced functional classifications and report an appropriate performance estimate. The registry record does not provide such an estimate or the analysis method for obtaining one.

The design is single-group and non-randomized. Thus, its planned position-based observations are not equivalent to a randomized comparison between treatment arms. In general, randomization can help balance prognostic factors across comparison groups, while a within-participant design can control some stable differences between people when repeated measurements are available. These are general design principles; the registry record does not report a completed analysis that would quantify either type of comparison.

Precision and uncertainty

In general, a point estimate describes the value estimated from observed data, while a confidence interval communicates uncertainty around that estimate under the statistical method used. Wider intervals generally indicate less precision, and narrower intervals generally indicate more precision, subject to the validity of the method and assumptions. No endpoint estimate or confidence interval is reported in the registry record. It is therefore not possible to characterize either the observed response or its precision.

Variability matters because participants may differ in their baseline pulse rate or in how their pulse rate responds to a position change. A group average alone may not describe those differences. General methods for continuous outcomes may estimate an average response and its uncertainty, or may model participant-level trajectories, but the choice depends on the scientific question and the available data. The registry does not report a variance estimate, distributional assessment, outlier approach, or a planned method for handling repeated observations.

Planning calculations are not trial results

The record describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a specified fraction of the observed effect, and distinguishes participant counts per arm from total events for time-to-event calculations. These are general planning assumptions, not evidence that this study used a two-arm design: its registered design is single-group, with no randomized comparison. A planning calculation estimates a sample size under stated assumptions; it does not demonstrate that a study had a particular probability of detecting an effect after the study has been conducted.

Because the registry record does not report an analyzed observed effect for the primary endpoint, an effect-based planning illustration cannot be read as a trial finding. In general, planning values depend on the assumed effect, variability, test, allocation, and other design choices. The record does not report a study-specific sample-size justification or enough outcome information to evaluate how a planning calculation relates to the enrolled participants.

Over-dispersion is a general concern when observed variability exceeds what a chosen statistical model assumes. If present, it can make standard errors too small and confidence intervals too narrow unless the analysis accounts for it. The registry record does not report a model for this endpoint or data with which to assess over-dispersion; it should not be assumed to have occurred. More broadly, no statistical test, model diagnostics, adjustment procedure, or sensitivity analysis is reported. The available methodological information is therefore limited to the measurement plan and the fact that outcome analysis did not take place.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists two outcome measures and zero analyses. It does not report a multiplicity strategy, such as a hierarchy of outcomes, a designated family of statistical tests, or an adjustment for testing more than one outcome. Without reported analyses, it is not possible to determine how multiple outcomes or multiple comparisons across tilt-table positions would have been handled. In general, multiple statistical tests can increase the chance of a false-positive result if each is interpreted without accounting for the broader testing plan. That is a general issue, not evidence that false-positive findings occurred in this study.

The primary endpoint description identifies average pulse rate from baseline to 30 minutes and describes repeated measurements across positions. The record does not state whether the planned analysis would have treated position comparisons as separate tests, estimated an overall pattern, or used another approach. No statistical analysis plan or prespecified testing hierarchy is reported in the registry record.

Missing-data handling is also not reported. The registry does not say whether any participants missed measurements, how incomplete measurement sequences would have been handled, or whether participants with partial data could contribute to an analysis. The statement that the data were not sent for analysis concerns the study’s overall analysis process; it does not specify the amount or pattern of participant-level missingness.

The analysis populations are not described. The record does not identify an intention-to-treat population, a per-protocol population, or a population with evaluable measurements, nor does it report how many participants were included in any analysis. Since the study has zero reported analyses, there are no reported analysis-set counts to interpret. These omissions prevent assessment of whether the planned sample and measurements were sufficient for the intended comparisons.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event record lists the CVInsight(TM) group with 10 participants at risk for serious adverse events and 0 participants affected. It also lists 10 participants at risk for other adverse events and 0 participants affected. These are the registry’s reported counts for the group; they do not show that a complete safety evaluation was performed or that no unrecorded events occurred.

The death count is not reported in the registry record. No serious adverse-event terms are listed. Because the study was terminated and the data were not analyzed, the event counts should be read as the registry entries, not as evidence of a comprehensive assessment of safety. The record does not explain the duration or completeness of event collection, provide event-level details, or describe how adverse events were solicited and classified.

In general, an observed count of zero in a small enrolled group does not establish that an event cannot occur. It also does not provide a precise estimate of the frequency of uncommon events. Here, the posted safety figures are descriptive counts for the registered group, and the available information does not support broader conclusions about safety or comparisons with another group.

12. What the Result Does, and Does Not, Mean

The record documents an intended study of a non-invasive cardiac functional health status measurement device. It describes a plan to measure pulse rate and blood pressure at different tilt-table positions and to compare physiological measurements with adult and pediatric functional classifications. It also records that 10 participants were enrolled and that the study status is terminated.

What the record does not provide is an analyzed primary endpoint. The stated average pulse-rate measure has no reported numerical value, and there is no reported estimate of change, uncertainty, or association with NYHA or NYPHF classification. There is consequently no statistical result from which to judge whether pulse-rate behavior distinguished the categories, how large any difference might have been, or how precisely it was estimated.

The study also cannot be interpreted as a comparison of CVInsight(TM) against a control device or an alternative treatment. It is registered as a single-group study with no randomized allocation. The position changes are part of the planned measurement procedure, not a separate control arm. No like-for-like control comparison is reported.

In general, a planned measurement method may be scientifically interesting even when its performance remains unestablished. A completed discrimination analysis would require usable measurements, a defined comparison with the referenced classification, and a reported estimate with uncertainty. Those results are not reported in the registry record. The reason recorded for the absence of analysis is that the data were not sent to the contract company and the University of Florida lacked the software package needed to compile them.

These registry entries do not show that the device succeeded or failed, nor do they establish a clinical effect. They describe an intended evaluation and its incomplete statistical record. Planning illustrations, if considered, are not observed results and cannot replace the missing analysis. The scope of any conclusion should remain limited to what is documented: a terminated single-group study, a defined measurement plan, and no reported analysis of the primary outcome.

13. Why This Trial Matters Statistically

This study is statistically notable because its main objective concerns measurement discrimination, yet its record contains no analyzed measurements. That distinction matters: a stated scientific question and a clearly described endpoint are not the same as evidence that the endpoint answers the question. Here, the registry specifies the proposed pulse-rate assessment and the functional classifications it was meant to relate to, but does not report whether the relationship was evaluated.

The design also highlights the importance of matching the statistical question to the design. A single-group study can collect repeated measurements under different conditions, and those observations may describe physiological responses. It does not, by itself, provide a randomized comparison between a device and a control or between treatments. Readers should therefore interpret the planned position changes as measurement conditions, not as evidence from independent comparison arms.

The record further illustrates why outcome analysis and data infrastructure are part of the evidence chain. The stated reason for the absence of analysis is that the data were not sent to the contract company and the University of Florida did not have the software package needed to compile them. Without compiled, analyzed data, no estimate or measure of precision can be reported, regardless of whether an endpoint and collection procedure were specified.

Finally, the record distinguishes enrollment from an analyzable sample. The listed enrollment is 10, but the number with completed, usable measurements is not reported in the registry record. The absence of analysis means that sample size alone cannot establish the information available for the intended question. These features make the record useful for understanding planned design and reporting limitations, while leaving the device’s discriminatory performance undetermined.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The most consequential limitation is that the primary outcome was not analyzed. The registry states that the study was terminated and that data were not sent to the contract company for analysis because the University of Florida did not have the software package needed to compile the data. No pulse-rate results, estimates of uncertainty, or analysis relating measurements to functional classifications are reported.

The study is single-center, non-randomized, and single-group, with an enrollment of 10. There is no separate control group, so the design does not support a randomized comparison with another device or treatment. The registry record does not report participant characteristics, the adult-to-pediatric composition, completion of the planned assessment, or the number of participants with usable data. Representativeness and the analysis population therefore cannot be assessed.

The measurement plan describes changes across tilt-table positions, but the record does not specify whether every participant was assessed in both the passive leg raise and orthostasis head raise positions. It also does not report the timing or frequency of repeated readings, the detailed procedure for deriving the average from the graph, or the statistical model intended for repeated measurements. No method for missing observations, outliers, or participant-level variability is reported.

The registry lists two outcome measures but no analyses, and it does not report a multiplicity plan, formal statistical analysis plan, or sample-size justification. These omissions are especially relevant to interpreting any future comparison across several measurement conditions, but there are no reported results to evaluate under such a plan. The safety record provides counts but does not describe event collection completeness or duration. Overall, the available record supports description of the intended study, not assessment of endpoint performance or broad generalization.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Developing a Non-invasive Cardiac Functional Health Status Measurement Device — NCT01877343.
• Registry record last updated 2016-02-10; status last verified 2016-02.
• Results first posted 2016-02-10.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT01877343, sponsored by the University of Florida, is a terminated, single-center, non-randomized, single-group study of CVInsight(TM) in adults and children with heart failure. The registry lists enrollment of 10 and dates of 2013-06 for study start and 2015-01 for primary completion.

The planned assessment used tilt-table position changes and pulse-oximeter and blood-pressure measurements. The primary endpoint was average pulse rate from baseline to 30 minutes, intended to be considered alongside adult NYHA and pediatric NYPHF functional classifications. The registry lists two outcome measures and zero analyses.

The record says that data were not sent to the contract company for analysis because the software package needed to compile them was unavailable to the University of Florida. No analyzed primary outcome is reported. Serious and other adverse-event counts list 0 affected participants among 10 at risk in each category; deaths are not reported in the registry record.