This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for REALIsM-HF Pilot Study (NCT03507439), a na na study. The primary outcome is Daily Steps Count.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03507439 |
| Phase | NA |
| Condition | Heart Failure |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 27 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bayer |
| Results posted | Yes |
2. Clinical Question
Population
Participants had heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). The HFrEF group was described as having an ejection fraction at most 35%, and the HFpEF group as having an ejection fraction at least 45%. The study enrolled 27 participants overall.
Intervention
Participants wore the AVIVO Mobile Patient Management System or VitalPatch biosensor for monitoring periods. They also wore the DynaPort Move Monitor belt for monitoring periods. The study explored the devices under real-life conditions rather than assigning a treatment intended to change heart failure.
Comparator
There was no randomized control group. The record describes a single-group study with no allocation, and the HFrEF and HFpEF groups are not like-for-like controls. Any comparisons between the groups would need to account for their different clinical definitions and should not be read as randomized comparisons.
Primary question
The primary outcome was daily steps, measured with the DynaPort Move Monitor at Day 9 and Day 77. The study aimed to explore whether device-based measures could capture clinically relevant changes over time and how those measures related to conventional outcomes, including six-minute walking distance, biomarkers, and clinical events. It also aimed to examine practical feasibility in real-life conditions.
3. Trial Design
REALIsM-HF Pilot Study was a completed, single-group device-monitoring study sponsored by Bayer. The registry reports an enrollment of 27 and describes participants in HFrEF and HFpEF groups. Allocation is recorded as not applicable, and masking as none. These design features mean the study was not a randomized treatment comparison, and the two heart-failure groups should not be interpreted as intervention and control arms.
Participants used one of two patch-based devices, the AVIVO Mobile Patient Management System or VitalPatch biosensor, and the DynaPort Move Monitor belt. For both heart-failure groups, the patch monitoring periods began on Day 0, Day 9, Day 16, Day 77, and Day 84. The belt was used for two monitoring periods. The registry description does not fully specify every operational detail of the belt schedule.
The primary outcome was daily step count assessed at Day 9 and Day 77. The stated analysis population was participants with DynaPort parameters for at least one wearing period. Secondary outcomes included six-minute walking distance, sleep movements and patterns, sit-to-stand behaviour, quality-of-life measures, and copeptin. The record lists 42 outcome measures overall, but does not report numerical primary-outcome results or analysis results.
The study began on 2018-04-06, reached primary completion on 2020-12-30, and is recorded as completed. The phase is listed as not applicable. A detailed statistical analysis plan, the sample-size justification, and any planned interim analyses are not reported in the registry record.
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: Overall, 29 participants were screened, of which 2 participants were screening failures and 27 participants received at least one device.
Overall Study
| Stage | HFrEF | HFpEF |
|---|---|---|
| STARTED | 14 | 13 |
| COMPLETED | 10 | 11 |
| NOT COMPLETED | 4 | 2 |
Reasons for not completing this period:
| Reason | HFrEF | HFpEF |
|---|---|---|
| Other | 2 | 1 |
| Withdrawal by Subject | 1 | 0 |
| Death | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: Device set (DES): All participants with DynaPort parameters for least one wearing period
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.
Population: Full analysis set (FAS) : all participants that were enrolled into the study and that wore at least one device
| Characteristic | Unit | HFrEF | HFpEF | Total |
|---|---|---|---|---|
| Participants analysed | 14 | 13 | 27 | |
| Age, Continuous | Years | 64.7 (SD 9.2) | 73.8 (SD 8.9) | 69.1 (SD 10.0) |
| Sex: Female, Male: Female | Participants | 1 | 6 | 7 |
| Sex: Female, Male: Male | Participants | 13 | 7 | 20 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 4 | 3 | 7 |
| Race (NIH/OMB): White | Participants | 10 | 9 | 19 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
| 6-minute walking distance (6MWD) | Meters (m) | 382 (253 to 575) | 291 (92 to 506) | 337 (92 to 575) |
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire score: Total Symptom Score | Scores on a scale | 64.0 (53 to 100) | 33.0 (4 to 100) | 61.0 (4 to 100) |
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire score: Clinical Summary Score | Scores on a scale | 68.0 (37 to 98) | 41.0 (8 to 83) | 66.0 (8 to 98) |
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire score: Overall Summary Score | Scores on a scale | 67.0 (29 to 96) | 43.0 (8 to 81) | 64.5 (8 to 96) |
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire score: Physical Limitation Score | Scores on a scale | 71.0 (21 to 96) | 54.0 (8 to 75) | 65.0 (8 to 96) |
| Copeptin | Picomoles per litre (pmol/L) | 47.047 (SD 37.744) | 31.551 (SD 23.693) | 39.755 (SD 31.960) |
| Galectin-3 | Nanograms per milliliter (ng/mL) | 15.622 (SD 9.403) | 12.265 (SD 4.988) | 14.042 (SD 7.621) |
| Growth differentiation factor 15 (GDF 15) | Picograms per millilitre (pg/mL) | 4740.2 (SD 4840.0) | 2689.6 (SD 1512.6) | 3775.2 (SD 3718.5) |
| Human interleukin-1 Receptor 4 / ST2 | Picograms per litre (pg/L) | 35.09 (SD 14.33) | 28.69 (SD 18.45) | 32.08 (SD 16.20) |
| Human Insulin-like Growth Factor Binding | Nanograms per milliliter (ng/mL) | 311.6 (SD 241.0) | 289.0 (SD 109.7) | 305.5 (SD 207.8) |
| N-terminal propeptide of BNP (NT-proBNP) | Nanograms per liter (ng/L) | 11972.4 (SD 20747.7) | 2927.4 (SD 3742.5) | 8015.3 (SD 16020.7) |
| High sensitive Troponin T | Picograms per millilitre (pg/mL) | 58.58 (SD 46.30) | 22.73 (SD 6.99) | 42.89 (SD 38.74) |
| Blood pressure: SBP | millimetre of mercury (mmHg) | 114.0 (SD 17.6) | 124.0 (SD 15.5) | 119.2 (SD 16.9) |
| Blood pressure: DBP | millimetre of mercury (mmHg) | 69.3 (SD 11.9) | 66.3 (SD 12.0) | 67.7 (SD 11.7) |
| Heart rate | Beats per minute | 69.5 (SD 12.8) | 78.7 (SD 17.0) | 74.3 (SD 15.5) |
6. Primary Endpoint
The registry lists the primary outcome as Daily Steps Count, measured over At Day 9 and Day 77.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Steps |
| Endpoint classification | Continuous Endpoint |
Daily steps count is a continuous measure of physical activity. The study measured it with the DynaPort Move Monitor and described it as reflecting the amount of daily physical activity. The primary outcome was assessed at Day 9 and Day 77, allowing the study to explore measurements at different points during follow-up.
Step counts can provide a device-based measure of activity in daily life, in contrast to an assessment made only during a scheduled functional test. Repeated monitoring may help researchers examine whether activity patterns change over time and whether those patterns align with measures such as six-minute walking distance, biomarkers, or clinical events. That is the general rationale for studying such measures as potential trial endpoints; it does not establish that a step count is a validated or clinically meaningful endpoint in this study.
The registry specifies that the reported summary is a mean with standard deviation. For the primary outcome, the analysis population consists of participants with DynaPort parameters for at least one wearing period. The numerical means, standard deviations, and any comparison or estimate for the primary endpoint are not reported in the registry record. Consequently, the magnitude, direction, and precision of any change in daily steps cannot be assessed from the posted record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the question and measurement schedule, but does not report numerical results for daily steps at Day 9 or Day 77. It therefore does not establish whether the mean step count changed, how large any change was, or how variable the measurements were. The record also does not report a confidence interval or a statistical test for the primary outcome. Without these results, the primary endpoint cannot be interpreted in terms of estimated change or precision.
The study was a single-group pilot, not a randomized comparison. A measurement at a later time can be compared descriptively with an earlier measurement, but a change over time alone cannot identify why that change occurred. General factors such as ordinary variability, changes in participants’ circumstances, device wear, or missing measurements may affect observed patterns. The registry record does not report enough outcome detail to distinguish these possibilities.
The HFrEF and HFpEF groups were defined using different ejection-fraction criteria. Although the record gives separate safety counts for these groups, it does not make them randomized comparison groups. A difference between groups, if estimated, could reflect their differing clinical characteristics rather than a device effect. No group comparison for daily steps is reported.
The study’s stated aims included exploring relationships between device measurements and conventional outcomes, as well as the feasibility of real-life monitoring. The listed secondary outcomes include six-minute walking distance, sleep measures, sit-to-stand behaviour, quality of life, and copeptin. However, numerical results for these outcomes and analyses of their relationships are not reported in the registry record. The presence of outcome measures in a registry does not itself show that they were successfully collected or that an association was found.
The safety record reports serious adverse events and other adverse events separately by heart-failure group. These counts describe events recorded during the study; without a randomized control group and additional context, they do not establish whether the devices caused an event or whether event frequency differed because of device use. The registry record also lists deaths in both groups, but does not provide enough information to attribute cause or relationship to device monitoring.
Any sample-size illustrations based on an observed effect should be read as planning exercises, not as observed evidence or as the study’s original design justification. The registry record does not report the numerical primary-outcome results needed to evaluate such an effect. Overall, the posted record documents a pilot study design and selected safety counts, while leaving the primary outcome’s magnitude and precision unavailable.
9. Statistical Methods Explained
The primary measure is continuous: daily step count. The registry identifies the mean as the summary parameter and standard deviation as its dispersion measure. A mean describes the central level of observed step counts, while a standard deviation describes how spread out individual observations are around that mean. These summaries are descriptive; by themselves, they do not show whether a difference over time is attributable to a device or to another factor.
A confidence interval is a general statistical tool for expressing the precision of an estimated quantity. It gives a range of values compatible with the data and the method used, under the method’s assumptions. A narrow interval indicates greater precision than a wide one, but neither width nor statistical significance establishes clinical importance. No confidence interval for daily steps is reported in the registry record, so precision cannot be judged from the posted primary-outcome information.
Comparisons across time require attention to which participants contribute data at each assessment. The stated primary-outcome population includes participants with DynaPort parameters for at least one wearing period. This definition does not say how many participants contributed data at each time point, whether the same participants contributed at both points, or how incomplete device records were handled. Those details are not reported in the registry record. If the set of participants with usable measurements differs over time, a change in group averages may partly reflect that change in membership.
Repeated measurements from the same participant are generally related rather than independent. In general, an analysis of repeated observations should account for that within-participant relationship if it is estimating change or testing a time effect. The registry record does not report the statistical model, the treatment of repeated measurements, or whether any adjustment was made for baseline characteristics. It is therefore not possible to determine the specific method used to estimate a change in daily steps.
Variation in activity between participants can be substantial in real-life monitoring. General statistical methods may address unequal variation or over-dispersion when the data show more variability than a model expects. Whether over-dispersion was assessed, and whether any such method was used, is not reported in the registry record. The record also does not report how the continuous step-count data were checked for unusual values or distributional features.
Multiplicity is relevant because many outcomes or comparisons can create multiple opportunities to identify an apparently notable result. The registry lists 42 outcome measures overall, including measures of walking distance, sleep, sit-to-stand behaviour, quality of life, and copeptin. No analysis rows are posted. A multiplicity adjustment or strategy for prioritizing outcomes is not reported in the registry record. As a result, the degree to which the study planned to account for multiple outcomes cannot be determined.
The study’s design does not include random allocation, and the registry records no masking. These are important features when interpreting any group contrast or subjective measurement. In general, randomization can help balance known and unknown characteristics between groups, while masking can reduce some forms of expectation-related influence. This study was a device-monitoring pilot rather than a randomized therapeutic trial, so its purpose and design do not support a treatment-effect interpretation. The registry record does not describe additional procedures to reduce measurement or observer bias.
Sample-size calculations are useful for planning a future study, but a planning calculation is not evidence that the current study had adequate power to detect an effect. The stated illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect set as a fraction of the observed effect. They are planning illustrations rather than the trial’s design rationale. The registry record does not report the original sample-size justification. Any sample sizes generated under those assumptions should be interpreted as participants per arm for the stated power target, not as observed power or as a property of the completed study.
The primary outcome is a mean, but the registry record does not report a primary-endpoint estimate, standard deviation, confidence interval, or p-value. It also does not report the analysis population counts at each assessment, a missing-data method, or whether any sensitivity analysis was conducted. Those omissions prevent an independent assessment of the endpoint analysis and its robustness.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 42 outcome measures overall. The secondary outcomes named in the record include six-minute walking distance, sleep movements and patterns, sit-to-stand behaviour, several quality-of-life measures, and copeptin. Considering many outcomes can increase the chance of apparently notable findings arising by chance when each is examined separately. General approaches include defining a primary outcome in advance, limiting confirmatory comparisons, or adjusting inference to account for multiplicity. The registry record does not report a multiplicity strategy, and no outcome analysis rows are posted.
The primary-outcome population is described as participants with DynaPort parameters for at least one wearing period. The record does not report the number with usable daily-step data at each assessment, the reasons measurements may be unavailable, or how missing observations were handled. It also does not say whether participants with only one wearing period contributed to each time-specific summary. These omissions make it difficult to assess whether the reported analysis population, if analyzed, would represent all enrolled participants at both time points.
In general, complete-case summaries can be difficult to interpret if the availability of measurements is related to activity, health status, or device use. Methods such as imputation or likelihood-based models require assumptions about why data are missing. Which, if any, of these methods was used is not reported in the registry record. The record also does not describe sensitivity analyses for missing data or define additional analysis populations beyond the stated device-set population.
Because numerical endpoint results and analysis details are absent, neither the influence of missing measurements nor the handling of multiple outcomes can be evaluated from the posted record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| HFrEF | 5 | 14 | 35.7% |
| HFpEF | 3 | 13 | 23.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| HFrEF | 1 of 14 |
| HFpEF | 1 of 13 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| HFrEF | 8 of 14 |
| HFpEF | 9 of 13 |
Most frequent serious adverse event terms
| Event term | Organ system | HFrEF | HFpEF |
|---|---|---|---|
| Cardiac failure | Cardiac disorders | 3 of 14 | 0 of 13 |
| Acute myocardial infarction | Cardiac disorders | 1 of 14 | 0 of 13 |
| Cardiac failure chronic | Cardiac disorders | 1 of 14 | 0 of 13 |
| Ventricular tachycardia | Cardiac disorders | 0 of 14 | 1 of 13 |
| Hydrocele | Congenital, familial and genetic disorders | 1 of 14 | 0 of 13 |
| Diverticulitis | Infections and infestations | 0 of 14 | 1 of 13 |
| Pneumonia legionella | Infections and infestations | 0 of 14 | 1 of 13 |
| Klebsiella sepsis | Infections and infestations | 1 of 14 | 0 of 13 |
| Hypokalaemia | Metabolism and nutrition disorders | 0 of 14 | 1 of 13 |
| Osteitis | Musculoskeletal and connective tissue disorders | 1 of 14 | 0 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | HFrEF | HFpEF |
|---|---|---|---|
| Oedema peripheral | General disorders | 2 of 14 | 3 of 13 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1 of 14 | 1 of 13 |
| Cardiac failure | Cardiac disorders | 1 of 14 | 0 of 13 |
| Cardiovascular disorder | Cardiac disorders | 1 of 14 | 0 of 13 |
| Hyperthyroidism | Endocrine disorders | 1 of 14 | 0 of 13 |
| Thyroid mass | Endocrine disorders | 1 of 14 | 0 of 13 |
| Tongue disorder | Gastrointestinal disorders | 1 of 14 | 0 of 13 |
| Face oedema | General disorders | 1 of 14 | 0 of 13 |
| Pain | General disorders | 0 of 14 | 1 of 13 |
| Cellulitis | Infections and infestations | 0 of 14 | 1 of 13 |
Serious events with the highest arm-level rate: cardiac failure (21.4%), ventricular tachycardia (7.7%), diverticulitis (7.7%), pneumonia legionella (7.7%), hypokalaemia (7.7%).
The registry reports serious adverse events separately for HFrEF and HFpEF. In HFrEF, 5 of 14 participants at risk had a serious adverse event; in HFpEF, 3 of 13 participants at risk had a serious adverse event. Other adverse events were reported for 8 of 14 participants at risk in HFrEF and 9 of 13 in HFpEF. The record lists 1 death in each group. These are counts, not estimates of a causal effect of device monitoring.
The registry also lists serious-event terms and percentages, including Cardiac failure at 21.4%, and Ventricular tachycardia, Diverticulitis, Pneumonia legionella, Hypokalaemia, and Syncope at 7.7% each. The denominator used for these percentages and whether participants could contribute more than one term are not reported in the registry record. The percentages should therefore be read as registry-listed summaries, not as a basis for deriving additional rates.
Safety counts in a small, single-group pilot describe what was recorded among participants; they do not by themselves establish whether an event was caused by a device. There is no randomized control group for comparison, and the registry does not provide event timing, severity details beyond the serious-event classification, or causal assessments for these counts.
12. What the Result Does, and Does Not, Mean
REALIsM-HF was designed to explore wearable monitoring in real-life conditions among participants with HFrEF or HFpEF. Its primary outcome, daily steps measured by the DynaPort Move Monitor at Day 9 and Day 77, addresses the feasibility and potential value of capturing activity outside a conventional clinic-based test. The broader study aims included exploring relationships with established measures and identifying potential endpoints for future heart-failure trials.
The posted record does not report numerical results for daily steps or the listed secondary outcomes. It therefore does not establish the amount or direction of any change in activity, the precision of an estimate, or whether device measurements were associated with six-minute walking distance, biomarkers, or clinical events. The stated research aims should not be mistaken for findings.
The record does document monitoring schedules, outcome definitions, and selected adverse-event counts. These details can inform understanding of the study’s scope, but the record does not give a complete account of device adherence, data completeness, missing-data handling, or statistical analyses. Feasibility cannot be judged from the stated aims and schedules alone.
As a single-group pilot without random allocation, the study is not suited to a causal comparison between devices or between heart-failure groups. The HFrEF and HFpEF groups have different clinical definitions, and no like-for-like control comparison is described. Any observed time pattern, if numerical results were available, would require cautious interpretation and would not on its own show that device monitoring caused a change.
The study may help define questions and measurement procedures for later research, but the registry record does not establish that daily steps are a validated endpoint, that the devices improve outcomes, or that a specific monitoring approach is superior. Those conclusions would require results and study designs that address the relevant measurement, comparison, and causal questions.
13. Why This Trial Matters Statistically
This pilot is statistically relevant because it focuses on the measurement process as well as on a clinical population. Wearable monitoring can generate repeated observations under ordinary living conditions, creating practical questions about adherence, completeness, variability, and how measurements relate to conventional endpoints. These are central issues when considering whether a device-derived measure could be used in a future trial.
Daily steps are a continuous activity measure, and the study specifies both a time frame and a device for assessing them. Defining the measure and the analysis population is an important first step toward reproducible endpoint work. The registry describes participants with DynaPort parameters for at least one wearing period as the primary analysis population. However, the record does not report time-specific participant counts or outcome estimates, so the completeness and statistical precision of the endpoint cannot be evaluated.
The study also illustrates why pilot findings and confirmatory evidence have different roles. A pilot may help identify operational challenges and guide a later design, while a randomized comparison is generally needed to support a causal treatment contrast. Here, no randomized comparison is described, and the two heart-failure groups are not equivalent control groups.
Statistically, the main contribution documented by the record is the planned framework for exploring device measurements alongside conventional outcomes. The absence of posted numerical endpoint analyses limits conclusions about performance, associations, or change. Future interpretation would require transparent outcome estimates, uncertainty intervals, analysis-population details, and information about missing measurements and multiplicity. The record’s planning illustrations should also remain distinct from evidence about what the completed study observed.
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 main limitation for interpreting outcomes is that numerical daily-step results are not reported in the registry record. Means, standard deviations, estimates of change, confidence intervals, and statistical tests are unavailable. Numerical results for the secondary outcomes are also not reported, preventing assessment of the intended relationships with walking distance, biomarkers, clinical events, sleep, behaviour, or quality of life.
The study has a single-group design, no allocation, and no masking. It does not provide a randomized device comparison or a randomized control group. The HFrEF and HFpEF groups are defined by different ejection-fraction criteria and should not be treated as interchangeable controls. The enrollment was 27, and the record does not provide detailed outcome-specific sample sizes or time-specific data availability.
The primary analysis population includes participants with DynaPort parameters for at least one wearing period, but the registry does not report how missing measurements were handled or whether the same participants contributed at both primary assessment times. Device adherence, reasons for unavailable readings, and sensitivity analyses are not reported. The statistical model, multiplicity approach, sample-size justification, and any interim analyses are also not reported in the registry record.
Safety counts are available, but causal attribution and the denominator for the listed serious-event percentages are not reported. These limitations restrict interpretation to the study description and recorded counts, rather than conclusions about device effects or endpoint performance.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: REALIsM-HF Pilot Study — NCT03507439.
- Registry record last updated 2023-07-03; status last verified 2022-07.
- Results first posted 2023-07-03.
- 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.
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18. Record Summary
REALIsM-HF Pilot Study (NCT03507439) was a completed, single-group device-monitoring study sponsored by Bayer, with an enrollment of 27. It included participants with HFrEF and HFpEF and explored the AVIVO Mobile Patient Management System, VitalPatch biosensor, and DynaPort Move Monitor under real-life conditions.
The primary outcome was daily steps measured by DynaPort at Day 9 and Day 77, summarized as a mean with standard deviation. The record lists 42 outcome measures overall and reports selected adverse-event counts by heart-failure group. Numerical primary and secondary outcome analyses are not reported in the registry record. The study was not randomized, and the two clinical groups are not like-for-like controls.