Myocardial Hemodynamic Effects of Levosimendan: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Myocardial Hemodynamic Effects of Levosimendan (NCT00585104), a na phase 2 study. The primary outcome is Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter..

2. Clinical Question

In plain terms, this study was designed to observe an early hemodynamic measure during treatment rather than estimate a contrast between treatment and control. A within-person change can describe how the recorded measure differed over the stated interval, but by itself it cannot distinguish a treatment effect from time-related changes, measurement variation, or other influences. The record identifies heart failure as the condition and levosimendan as the intervention, but it does not report the primary endpoint estimate needed to describe the direction or size of the observed change.

3. Trial Design

The registry classifies this as a phase 2, single-group study of levosimendan for heart failure. Enrollment was 10. The record gives a start date of 2006-09, primary completion in 2008-12, and a completed status. These dates describe the registry record; they do not supply additional information about recruitment or follow-up procedures.

There is no randomized control comparison reported. Allocation is recorded as not applicable, masking is recorded as none, and the model is single group. The arm description states that all randomized patients receive the drug, but that wording does not establish a separate randomized comparison: the registry's allocation field is not applicable, and the record explicitly identifies the study as not being a randomized comparison. The appropriate design description is therefore a single-group study, not a trial contrasting levosimendan with a control treatment.

The primary endpoint was the change in LVEDP from baseline to 30 minutes after levosimendan started. The registry identifies a mean as the summary parameter and standard deviation as the dispersion measure, with the pressure measured in mmHg. Complete endpoint data were available in 6 patients, despite enrollment of 10. The record says an intent-to-treat (ITT) analysis was performed, but it does not explain how that analysis handled the patients without complete data.

The registry lists one outcome measure and no analyses. It does not report a detailed protocol, a sample-size justification, an interim-analysis plan, or a statistical analysis plan. The record's sample-size illustrations use assumptions for a two-arm design, but those assumptions are not a description of this single-group study's actual design. No control-arm outcome or between-arm treatment contrast is reported.

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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Ten patients were enrolled. Complete data was available in 6 patients. The primary endpoint was change in left ventricular end diastolic pressure (LVEDP) from baseline to 30-minutes after starting levosimendan. An Intent to Treat (ITT) analysis was performed.

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 Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter., measured over From baseline to 30-minutes after levosimendan started..

Left ventricular end-diastolic pressure (LVEDP) is a pressure measurement recorded from the left ventricle at the end of diastole. The registry states that it was recorded using CD Leycom ConductNT software analysis and a pressure-volume catheter. The endpoint is the change in LVEDP from baseline to 30 minutes after levosimendan started, expressed in mmHg. The record identifies the mean as the endpoint summary and standard deviation as its dispersion measure.

As general context, a pressure-volume assessment can characterize aspects of cardiac pressure and volume behavior. A short-interval change in LVEDP is an indicator of a hemodynamic measure over the specified period; it is not, by itself, a complete measure of mechanical efficiency or a patient-centered clinical outcome. The study summary's stated hypothesis concerned improvement in mechanical efficiency using pressure-volume loop assessment, while the registered primary endpoint is specifically change in LVEDP. These should not be treated as interchangeable measurements.

The registry record does not report the baseline or follow-up mean, the mean change, its standard deviation, or an uncertainty interval. It therefore does not allow readers to determine the observed direction, size, or precision of the endpoint change. It also does not give enough detail to assess how the pressure measurement was collected beyond the stated catheter, software, and time point.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the endpoint summary mean?

The endpoint is continuous: LVEDP is recorded as a pressure in mmHg, and the registered quantity is a change between baseline and a follow-up measurement. The record specifies the mean as the summary parameter and standard deviation as the measure of dispersion. General explanation: a mean describes the average value or average change in a group, while a standard deviation describes the spread of individual measurements around that mean. Neither statistic is reported numerically for this endpoint in the registry record.

A mean change is different from a comparison of two independent groups. In a single-group before-and-after assessment, the relevant observations are measurements taken at two times in the same study context. The registry does not report the paired measurements, the mean change, or the variance of the changes. It is therefore not possible to reconstruct the estimate or assess whether the stated summary statistics correspond to a paired analysis.

What would a confidence interval communicate?

General explanation: a confidence interval describes the uncertainty around an estimated quantity under the assumptions of the statistical method. A narrower interval indicates greater precision, while a wider interval indicates less precision. It does not represent the range of individual patient responses. No confidence interval for the LVEDP change is reported in the registry record, so the precision of the primary endpoint estimate cannot be assessed.

A test result and an effect estimate answer different questions. General explanation: a test can evaluate compatibility of data with a specified null hypothesis, while an estimate and its interval describe the direction, size, and uncertainty of the effect. A p-value alone would not describe clinical magnitude. In this record, no primary endpoint p-value or effect estimate is reported, and the registry lists no analyses.

How should the design shape interpretation?

General explanation: random allocation and a concurrent comparator can help distinguish treatment effects from other causes of outcome variation. This study is recorded as single group, with allocation not applicable and no masking. The registry explicitly notes that it is not a randomized comparison. Consequently, a change over the short interval, if reported, would be descriptive of the observed group and would not by itself provide a controlled estimate of a treatment effect.

Masking is recorded as none. General explanation: masking can reduce the influence of expectations on some aspects of treatment delivery, measurement, or reporting, depending on the design. The record does not provide more detail about who knew treatment status or how LVEDP assessment was conducted. No additional claim about the practical consequences of masking can be made from this record.

What do the sample-size illustrations represent?

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 that non-time-to-event illustrations are expressed as participants per arm for 80% or 90% power. These are planning assumptions, not features of the actual single-group design. The registry record does not report a sample-size justification for this study, and no specific illustration result is available in the registry record for interpretation.

General explanation: a sample-size calculation estimates how many participants a hypothetical design would need under chosen assumptions about effect size, variability, allocation, and error rates. Such a calculation is not an observed result and does not show the probability that the completed study detected an effect. Planning illustrations based on an observed effect also inherit uncertainty from that effect estimate. They should not be described as observed power.

What is not available for evaluation?

The registry record does not report an outcome estimate, its uncertainty, or a primary endpoint test. It also does not report the detailed analysis model, assumptions for the endpoint analysis, or diagnostics. These omissions prevent an independent check of the statistical analysis or a quantitative assessment of the result. General explanation: for continuous outcomes, the adequacy of a mean-based analysis can depend on the measurement distribution, outliers, dependence between observations, and the analysis population. The record does not contain the participant-level data or summary detail needed to assess these features.

Dispersion is particularly relevant when observations vary substantially. General explanation: over-dispersion means that variability is greater than a model expects; if a model does not account for that extra variation, uncertainty can be understated. The registry identifies standard deviation as the dispersion measure but does not provide its value or describe a model that would require an over-dispersion assessment. No conclusion about the variability of LVEDP measurements can therefore be drawn.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Levosimendan, Compare Heart Function and Metabolis")
n   <- c(6)
m   <- c(5.67)
sp  <- c(4.32)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Levosimendan, Compare Heart Function and Metabolis  6  5.670  4.320  1.136  10.204

11. Multiplicity, Missing Data and Analysis Populations

The registry records one outcome measure and no analyses. The primary outcome is change in LVEDP from baseline to 30 minutes after levosimendan started. The record does not report a multiplicity plan, such as how inference would be handled across multiple endpoints, time points, or analyses. The presence of one listed outcome measure does not establish that no other outcomes or analyses were considered in a protocol; that information is not reported in the registry record.

General explanation: multiplicity arises when several statistical questions are examined, because repeated testing can increase the chance of at least one apparently notable finding. A prespecified analysis plan can clarify which outcome is primary and how additional analyses are interpreted. Since a detailed statistical plan is not reported, it is not possible to assess whether multiplicity adjustments were planned or needed.

The record says complete data were available in 6 patients and that an ITT analysis was performed. It does not describe the missing-data procedure or define exactly which patients were included in the endpoint calculation. The record does not state whether missing values were imputed, handled with a model, or excluded from a particular calculation. Those details are not reported in the registry record.

General explanation: missingness can affect an estimate when the availability of measurements is related to the outcome or to participant characteristics. Different assumptions about missing data can lead to different estimates. Reporting the number with observed measurements, the analysis population, and the handling method helps readers judge the risk of bias. The enrollment and complete-data figures alone do not reveal why data were unavailable or how the ITT analysis addressed them.

Thus, the record identifies an ITT analysis in its endpoint description but does not provide enough information to reproduce or evaluate that analysis. The registry's listing of no analyses also means no specific statistical analysis output is available for review.

12. 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 registry lists a single levosimendan group with 10 patients at risk for the serious-adverse-event entry and 0 affected. For other adverse events, it likewise lists 10 at risk and 0 affected. No serious adverse-event terms are listed. The death count is recorded as null, which is not the same as a reported count of zero; deaths are not reported in the registry record.

These entries are counts as recorded, not estimates of comparative risk. The study has no reported control group, so the safety figures cannot be used to compare levosimendan with another treatment or with no treatment. The record also does not provide event definitions, collection procedures, or information about the duration of safety monitoring. The figures should therefore be read as the registry's reported adverse-event counts, not as evidence that no adverse effects can occur.

General explanation: an observed count of zero in a study group does not establish that the underlying event risk is zero. The amount of information in a safety count depends on the size of the group, the observation period, and how events were sought and classified. Those considerations do not change the recorded counts, but they limit what can be inferred from them.

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

The registry documents a phase 2, single-group study of levosimendan focused on short-term change in LVEDP. It reports enrollment of 10 patients, complete primary-endpoint data for 6 patients, and an endpoint time frame from baseline to 30 minutes after levosimendan started. It also records an ITT analysis as having been performed.

The posted record does not report the actual primary endpoint result. There is no numerical mean change, standard deviation, confidence interval, or test result available in the registry information used for this analysis. Consequently, it is not possible to say whether the observed LVEDP changed in either direction, how large the change was, or how precisely it was estimated. The study summary's hypothesis about mechanical efficiency is not a numerical result and does not substitute for the registered LVEDP outcome.

Even if a within-group change estimate were available, the design would not provide a controlled comparison. General explanation: in an uncontrolled before-and-after study, the observed time change may reflect treatment, natural fluctuation, measurement variation, or other changes during the interval. A comparator can help separate these explanations, but none is reported for this study. This limits causal interpretation independently of the missing numerical outcome result.

The safety entries report 0 serious adverse events and 0 other adverse events among 10 at risk in the group. The record does not report a death count, because that field is null. These figures are descriptive registry entries and do not establish comparative safety.

Accordingly, the record supports a description of the study question, design, timing, enrollment, and data completeness. It does not support a conclusion that levosimendan did or did not change LVEDP or mechanical efficiency. No treatment recommendation or claim of benefit follows from the information recorded.

14. Why This Trial Matters Statistically

This trial is statistically notable for the distinction between an outcome being defined and an outcome being reported. The registry gives a specific primary endpoint, its measurement method, summary type, units, and time frame. Yet the numerical endpoint result is absent. Readers therefore have a clear description of what was intended to be measured, but not the estimate needed to evaluate the observed change.

The study also illustrates why design determines the scope of inference. A single-group baseline-to-follow-up assessment can be useful for describing a short-term measurement pattern, but it does not provide the same evidence as a controlled comparison. Without a comparator, the observed change cannot be separated from changes that might occur over time or from other sources of variation. Here, the absence of a reported estimate means even the descriptive pattern cannot be quantified.

Completeness is another important reporting issue. The registry states that 10 patients were enrolled and complete data were available in 6 patients, while also stating that an ITT analysis was performed. The missing-data handling and analysis population are not described. This makes it difficult to assess whether and how incomplete endpoint data could affect interpretation.

Finally, the record's hypothetical sample-size assumptions are not the design of the completed study. Distinguishing planning illustrations from actual trial methods helps prevent readers from treating hypothetical two-arm calculations as evidence about this single-group study or as observed power. Together, these points show why endpoint results, analysis details, and design context are all needed to interpret a clinical study statistically.

15. 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 this trial is the absence of a numerical primary endpoint result in the registry record. Although the endpoint is clearly named, no mean change, standard deviation, confidence interval, or test result is reported. This prevents assessment of direction, magnitude, and precision.

The study is single group and has no reported control arm. It is therefore not a randomized comparison. Any before-and-after change, if known, would not by itself distinguish an effect of levosimendan from time-related changes or other influences. Masking is recorded as none, and additional measurement safeguards are not described.

Enrollment was 10, while complete endpoint data were available in 6. The registry says an ITT analysis was performed but does not explain the analysis population, missing-data method, or reasons for incomplete data. This leaves uncertainty about how missing measurements may have influenced the analysis.

The registry record does not report a detailed protocol, sample-size justification, statistical analysis plan, interim-analysis plan, or multiplicity procedure. It also does not provide participant-level data, baseline endpoint summaries, or follow-up summaries. The sample-size assumptions recorded for planning illustrations describe a hypothetical two-arm setting and should not be mistaken for the actual single-group design.

Safety reporting is limited to the listed counts and does not include event definitions, monitoring duration, or a reported death count. These omissions constrain interpretation of both the endpoint and safety record; they do not establish that an unreported result or event was absent.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Myocardial Hemodynamic Effects of Levosimendan — NCT00585104.
• Registry record last updated 2013-05-21; status last verified 2013-05.
• Results first posted 2010-06-09.
• 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.

19. Record Summary

The registry record describes NCT00585104, “Myocardial Hemodynamic Effects of Levosimendan,” as a completed phase 2, single-group study in heart failure. The sponsor is the University of Utah. The recorded start date is 2006-09 and primary completion is 2008-12. Enrollment was 10.

The intervention was levosimendan. The primary endpoint was change in LVEDP from baseline to 30 minutes after treatment began, measured in mmHg using a pressure-volume catheter. The record identifies a mean and standard deviation as the endpoint summary and dispersion measures. Complete data were available in 6 patients, and the record states that an ITT analysis was performed.

No numerical primary endpoint result or analysis output is reported in the registry record. Safety entries list 0 serious adverse events and 0 other adverse events among 10 at risk; the death count is not reported in the registry record. The study has no reported comparator arm.