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 Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy (NCT00842023), a randomized phase 4 study. The primary outcome is Renal Function by Serum Creatinine.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00842023 |
| Phase | Phase 4 |
| Condition | Acute Decompensated Heart Failure |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 89 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Western University of Health Sciences |
| Results posted | Yes |
2. Clinical Question
Population
People with acute decompensated heart failure were enrolled. The registry record gives an enrollment of 89 but does not describe additional eligibility criteria or the characteristics of participants at baseline.
Intervention
The nesiritide group received an optional 2 mcg/kg bolus followed by an infusion of 0.01 mcg/kg/min for 48 hours. The registry record describes this as the nesiritide infusion arm.
Comparator
The comparator was nitroglycerin plus standard treatment. Nitroglycerin began at 10 mcg/min and was titrated every 5-10 minutes until symptom relief, systolic blood pressure at or below 90 mm Hg, or a maximum rate of 200 mcg/min. The registry record does not provide further details about standard treatment.
Primary question
The stated primary outcome was renal function measured by serum creatinine, including values and changes from baseline, at 24 hours and 48 hours. The study’s summary describes a broader purpose: assessing whether nesiritide modifies inflammatory and neurohormonal biomarkers without renal toxicity when an appropriate infusion duration is used. The registry record does not report the primary outcome values or a treatment comparison, so it does not establish what happened to serum creatinine in either group or whether the groups differed.
3. Trial Design
This was a randomized, open-label, parallel-group phase 4 trial. Participants were assigned to nesiritide infusion or nitroglycerin infusion. The registry record lists an enrollment of 89 and identifies Western University of Health Sciences as the sponsor. The study is marked completed; its listed start was 2006-07 and its primary completion was 2008-07.
Randomization is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics. That benefit depends on how random assignment was implemented and maintained. The registry record does not report the sequence-generation method, allocation concealment, or procedures used to protect allocation before assignment. Those details are therefore not reported in the registry record.
Masking is listed as none. This means the record does not describe the trial as blinded. Knowledge of assigned treatment can affect care, participant reports, and outcome assessment, although serum creatinine is a laboratory measure. The record does not explain whether laboratory staff or analysts were unaware of assignment.
A parallel-group design assigns participants to a treatment group and follows the groups over the same study period, rather than switching participants between treatments. The stated primary outcome timeframe includes baseline, 24 hours and 48 hours. The two regimens also differ in their administration: nesiritide has a specified infusion duration, while nitroglycerin is titrated according to the record’s stated clinical stopping conditions or maximum rate. No further treatment-administration or adherence results are reported in the registry record.
The registry lists three outcome measures but no analyses in its analyses field. It does not report the detailed protocol, the trial’s statistical analysis plan, or the basis for the enrollment target. These omissions limit how fully the design and its conduct can be assessed from the registry record alone.
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
| Stage | Nesiritide Infusion | Nitroglycerin Infusion |
|---|---|---|
| STARTED | 45 | 44 |
| COMPLETED | 45 | 44 |
| NOT COMPLETED | 0 | 0 |
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.
| Characteristic | Unit | Nesiritide Infusion | Nitroglycerin Infusion | Total |
|---|---|---|---|---|
| Participants analysed | 45 | 44 | 89 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 19 | 24 | 43 |
| Age, Categorical: >=65 years | Participants | 26 | 20 | 46 |
| Age Continuous | years | 68.6 (SD 14.1) | 66.8 (SD 17.2) | 67.7 (SD 16.7) |
| Sex: Female, Male: Female | Participants | 20 | 21 | 41 |
| Sex: Female, Male: Male | Participants | 25 | 23 | 48 |
| Region of Enrollment: United States | participants | 45 | 44 | 89 |
6. Primary Endpoint
The registry lists the primary outcome as Renal Function by Serum Creatinine, measured over Baseline, 24 hours, 48 hours.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mg/dL |
| Endpoint classification | Continuous Endpoint |
The primary outcome is renal function assessed using serum creatinine, reported as a mean with standard deviation and expressed in mg/dL. The record describes serum creatinine values and changes in serum creatinine at baseline, 24 hours and 48 hours. It does not identify a single time point as the sole treatment contrast or report the outcome values for either group.
Serum creatinine is a laboratory measure used to assess kidney function. In general, following a measure over time can show whether its observed values change during treatment, while comparing randomized groups can help assess whether their patterns differ. A baseline value provides a reference for interpreting subsequent measurements. A change from baseline and a value measured at follow-up are related but are not the same outcome summary, so the precise analysis matters.
A mean describes the average observed value, while a standard deviation describes the spread of individual observations around that mean. These summaries can help characterize a continuous outcome, but they do not by themselves show the uncertainty around a treatment difference or establish whether a difference is compatible with chance variation. The registry record does not provide means, standard deviations, changes, confidence intervals, or a statistical comparison for the primary outcome. The reported endpoint definition therefore identifies what was intended to be measured, but does not show the observed renal-function results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies serum creatinine as the primary outcome and gives its unit, summary type, and assessment times. It does not report group-level values at baseline, 24 hours or 48 hours. It also does not report changes from baseline, a between-group estimate, a confidence interval, or a p-value. Consequently, the posted record does not allow readers to determine the size or direction of any difference in the primary outcome.
The outcome description includes several time points and both values and changes in serum creatinine. These are multiple ways to represent the data, and the choice of a primary contrast can affect interpretation. The record does not specify which time point or summary was used for a formal comparison. It also marks the primary outcome as having several categories or time points and not reduced to one comparison. A single treatment-effect estimate should not be inferred from that description.
Random assignment is useful for comparing groups because it aims to balance prognostic factors at the start of treatment. It does not remove uncertainty from a relatively limited amount of observed data, nor does it substitute for reporting outcome estimates and their precision. The enrollment figure alone cannot show how precise the serum-creatinine comparison was. No confidence interval or other measure of statistical uncertainty for the primary outcome is reported in the registry record.
The study summary describes an interest in inflammatory and neurohormonal biomarkers as well as renal toxicity. However, the primary outcome information available in the registry record concerns serum creatinine, and the record does not give results for the other biomarkers. It would be inappropriate to infer biomarker findings from the study purpose or from the adverse-event entries.
The safety entries are separate from the primary renal-function outcome. The record lists serious adverse-event affected counts for both groups and selected serious-event terms with percentages, but it does not provide a treatment-effect analysis connecting those entries to serum creatinine. They should be read as descriptive safety reporting, not as a substitute for the missing primary-outcome comparison.
Overall, the registry record documents the question and the planned measurement schedule, but the primary results needed to judge the observed pattern and its precision are not reported in the registry record. That absence is not evidence that the groups were the same, and it is not evidence that one regimen was better. It means the comparative result cannot be assessed from the outcome information recorded.
9. Statistical Methods Explained
The registry record identifies the primary measure as continuous: serum creatinine summarized using a mean and standard deviation. It does not report an analysis estimate for the primary outcome. The explanations below describe general statistical concepts; they should not be taken as a description of analyses actually performed unless the registry record explicitly states that they were used.
What does a mean and standard deviation describe?
In general, a mean is the arithmetic average of observed measurements. It gives a compact description of the center of a group’s values, but it can be influenced by unusually high or low observations. A standard deviation describes how spread out measurements are around the mean. Together, the mean and standard deviation describe the data in a group; they are not the same as a treatment effect and do not alone quantify how precisely that effect has been estimated.
For repeated measurements, a group mean at a follow-up time and the mean change from baseline answer different questions. The former describes the group’s measured level at that time. The latter describes movement relative to the group’s starting measurements. A comparison can be based on follow-up values, changes, or a model that uses measurements over time. Which approach was intended for this trial is not reported in the registry record.
Why does the comparison need an estimate and uncertainty?
In general, a treatment comparison should state the estimated difference between groups in a clearly defined outcome and time point. A confidence interval expresses the range of values reasonably compatible with the observed data under the model and its assumptions. Its width conveys precision: a narrower interval indicates greater precision than a wider one. The interval also helps readers assess which effect sizes remain plausible, rather than relying only on whether a test crosses a significance threshold.
A p-value, when reported, describes how unusual the data would be under a specified null hypothesis and statistical model. It does not give the probability that the null hypothesis is true, nor does it indicate the clinical importance of an observed difference. The registry record does not report a p-value or confidence interval for the primary outcome, so neither statistical significance nor precision can be evaluated from the posted results.
Why do the assessment times matter?
Repeated measurements from the same participant are generally related to one another. In general, an analysis of measurements over time should account for that within-person dependence rather than treating every measurement as independent. A model may also need to represent treatment, time, and the interaction between treatment and time, depending on the question. These are general options, not reported methods for this trial. The registry record does not state the model, covariance assumptions, or contrast used.
Multiple time points can also create a multiplicity issue: testing several outcomes or time-specific comparisons can increase the chance of at least one apparently unusual result when no corresponding effect exists. Methods to address multiplicity can include defining one primary contrast in advance or adjusting inference across a family of comparisons. The registry record does not report a multiplicity strategy or identify one primary time-specific contrast.
What do the planning assumptions mean?
The registry record describes planning illustrations based on a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such calculations are planning scenarios, not observed power. They depend on assumptions about the effect and variability and do not show the probability that the completed trial detected an effect. The registry record does not report a sample-size justification from the trial’s own design, and any planning illustration should not be interpreted as an analysis of the trial’s actual results.
In general, a planning calculation asks how much information a proposed design might need to detect a chosen effect under specified assumptions. It is not evidence that the chosen effect occurred, and it does not replace a confidence interval for the observed treatment comparison. The record does not provide a reported primary-outcome effect from which readers could assess the assumptions against the observed result.
What cannot be inferred from the analysis record?
The registry lists zero analyses. That describes the analyses recorded in the registry; it does not prove that no analysis was conducted outside the registry. The statistical analysis plan, model diagnostics, handling of incomplete measurements, and analysis population are not reported in the registry record. Without those details and without outcome estimates, a reader cannot evaluate whether the analysis matched the planned question or how robust its conclusions would be to alternative assumptions.
For count outcomes, general statistical methods may need to account for over-dispersion, meaning variation greater than a simple model assumes. That issue is distinct from the continuous serum-creatinine endpoint, and the registry record does not describe such a model. In general, selecting a method should follow the outcome’s data structure and the estimand of interest; a method cannot be attributed to this trial when it is not reported.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is described across baseline, 24 hours and 48 hours, and includes serum creatinine values and changes. That creates more than one possible way to summarize or compare the outcome. The registry record explicitly notes that the primary outcome has several categories or time points and is not reduced to one comparison. It does not identify a single primary contrast for interpretation or report an adjustment for multiple comparisons.
In general, examining several time points or outcomes can increase the chance of finding at least one apparently notable result by chance. A prespecified hierarchy, a defined primary contrast, or an adjustment procedure can help make inference clearer. Whether any such plan was used is not reported in the registry record. The registry also lists three outcome measures, but their detailed results and relationships to any multiplicity plan are not reported.
Missing-data handling is not described. The record does not state whether all randomized participants contributed measurements at each time, how absent measurements were handled, or whether any imputation or sensitivity analysis was performed. It is therefore not possible to assess the impact of missing observations on the primary outcome.
The analysis population is also not reported. The registry record does not say whether the primary analysis included all randomized participants, only those who received assigned treatment, or another defined population. It lists zero analyses in its analyses field, but that entry should not be interpreted as proof that no analysis took place elsewhere. The analysis plan and its implementation are not reported in the registry 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 |
|---|---|---|---|
| Nesiritide Infusion | 12 | 45 | 26.7% |
| Nitroglycerin Infusion | 12 | 44 | 27.3% |
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 |
|---|---|
| Nesiritide Infusion | 0 of 45 |
| Nitroglycerin Infusion | 0 of 44 |
Most frequent serious adverse event terms
| Event term | Organ system | Nesiritide Infusion | Nitroglycerin Infusion |
|---|---|---|---|
| Death | General disorders | 7 of 45 | 7 of 44 |
| Symptomatic Hypotension | Cardiac disorders | 5 of 45 | 5 of 44 |
Serious events with the highest arm-level rate: death (15.9%), symptomatic hypotension (11.4%).
The serious adverse-event entries report 12 affected in the nesiritide group, with 45 at risk, and 12 affected in the nitroglycerin group, with 44 at risk. The other adverse-event entries report 0 affected in each group, with 45 and 44 at risk, respectively. These are descriptive registry counts; no comparative safety estimate or uncertainty measure is reported.
The registry also lists Death at 15.9% and Symptomatic Hypotension at 11.4% among the top serious-event terms. Those percentages are not assigned to a treatment group in the record, so they should not be attributed to either regimen or treated as group-specific rates. Death counts by group are not reported in the registry record.
In general, adverse-event counts and percentages need their definitions, observation period, and denominators to be interpreted. The entries do not establish whether events were judged related to treatment, when they occurred, or whether the groups differed statistically. They also do not replace the primary serum-creatinine outcome, which is not reported with results. These figures describe registry safety reporting only and should not be read as a complete assessment of comparative safety.
12. What the Result Does, and Does Not, Mean
The record documents a randomized comparison of nesiritide infusion with nitroglycerin infusion in acute decompensated heart failure. Its primary renal measure was serum creatinine, assessed at baseline, 24 hours and 48 hours. This establishes the topic and measurement schedule of the trial, but it does not provide the outcome data needed to determine how either group’s measurements changed or how the groups compared.
Without group-level values and a defined treatment-effect estimate, the direction and size of any observed difference are not reported in the registry record. Without a confidence interval, the precision of a comparison cannot be assessed. Without a stated analysis and treatment contrast, the role of the several listed time points and change summaries remains unclear. These gaps prevent a statistical conclusion about the primary endpoint from being drawn from the posted results.
The study summary also refers to inflammatory and neurohormonal biomarkers and to renal toxicity. The registry record does not report their results in the material describing the primary outcome. A stated study aim is not a finding. Similarly, the safety counts and selected serious-event terms do not supply the missing primary outcome estimates or establish a causal treatment effect.
This interpretation is limited to what the registry record reports. It does not show that the treatments produced the same outcome, and it does not show that one treatment produced a better outcome. The absence of reported results is a limitation of the available record, not a statistical result. The conclusions that can be drawn are therefore about the trial’s design and reporting, rather than about comparative efficacy or renal effects.
13. Why This Trial Matters Statistically
This trial is statistically notable for posing a randomized comparison while recording a continuous renal-function measure at multiple time points. Those features make the choice of estimand and analysis important. A follow-up value, a change from baseline, and a pattern across time are related but distinct summaries. Clear reporting of the intended contrast would help readers understand precisely which treatment question an estimate addresses.
Repeated observations also require attention to their dependence within participants. In general, treating related measurements as independent can misrepresent uncertainty. A suitable analysis should reflect the data structure and report its assumptions. The registry record does not identify the model or the contrast used, so readers cannot judge those choices for this trial.
The record’s description of multiple time points also highlights the role of multiplicity. When several comparisons are available, a prespecified primary question helps distinguish confirmatory inference from exploratory examination. The registry record does not report a single reduced comparison or a multiplicity procedure. That makes it especially important not to infer a result from selected time points or outcomes that are not reported.
Finally, the record illustrates the difference between documenting a study question and documenting its statistical answer. Randomization and a defined endpoint do not, by themselves, communicate an effect estimate or its precision. Reporting group summaries, a clearly specified comparison, and uncertainty would be necessary to assess what the data show. Those primary results are not reported in the registry record, so its statistical value for evaluating the treatment comparison remains limited.
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 principal limitation for interpreting this trial from the registry record is that primary outcome results are not reported. There are no serum-creatinine means, standard deviations, changes, treatment-effect estimates, confidence intervals, or p-values in the record. As a result, neither the observed outcome pattern nor its precision can be assessed.
The outcome is recorded at multiple time points, and the description includes both values and changes. The record does not specify which summary or comparison was primary, and it notes that the outcome has several time points rather than one reduced comparison. The statistical model and any approach to repeated measurements are not reported in the registry record.
The record marks masking as none and does not describe whether outcome assessors or laboratory staff were masked. It also does not provide allocation-concealment details, participant characteristics, adherence information, or details about standard treatment beyond the nitroglycerin arm description. These omissions limit assessment of trial conduct and comparability in practice.
Missing-data handling, the analysis population, multiplicity procedures, and the detailed statistical plan are not reported. The analyses field lists zero analyses, but that alone does not establish whether analyses were conducted outside the registry. Safety reporting is also limited: group-level death counts are not reported, and the listed serious-event percentages are not assigned to a treatment group. These limitations mean the registry record cannot support a full assessment of efficacy, precision, or comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy — NCT00842023.
- Registry record last updated 2013-08-30; status last verified 2013-08.
- Results first posted 2013-08-30.
- 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
The registry describes a completed, randomized, open-label, parallel-group phase 4 trial comparing nesiritide infusion with nitroglycerin infusion in acute decompensated heart failure. Enrollment is listed as 89. The primary outcome is serum creatinine, summarized as a mean with standard deviation at baseline, 24 hours and 48 hours.
The record does not report primary outcome values, a between-group estimate, or its uncertainty. It also does not report the analysis plan, missing-data approach, analysis population, or a single primary comparison across the stated time points. Serious adverse-event entries are descriptive, and the listed serious-event percentages are not assigned to groups. The registry record documents the study question and design, but does not provide enough outcome analysis to assess the primary treatment comparison.