The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study (NCT01102140), a randomized phase 2 study. The primary outcome is Thiobarbituric Reactive Substances (TBARS).

2. Clinical Question

In general, a randomized comparison is designed to assess differences between groups while reducing the influence of measured and unmeasured baseline factors. Random assignment is listed in the registry, but the method used to generate or conceal assignments is not reported in the registry record. This is a pilot study, and the record does not provide evidence that the primary comparison was completed. The posted information therefore describes the intended question and study structure, rather than an estimated treatment effect on TBARS.

3. Trial Design

The registry identifies this as a Phase 2, randomized, single-masked, parallel-group pilot study. It lists an enrollment of 20 and a status of terminated. The study began in 2010-07, and the primary completion date is listed as 2013-05-31. The record does not explain the reason for termination beyond its note that the principal investigator departed from the study center before any batches of samples were sent for analysis.

The two interventions were POMx, pomegranate polyphenol extract, and a sugar pill. The arm descriptions state that 15 subjects would receive 1000 mg of oral POMx for 12 weeks and that 15 subjects would receive a matching sugar pill for 12 weeks. These planned arm counts differ from the registry's enrollment figure, and the record does not explain the difference. The safety information lists 13 participants at risk in the POMx group and 7 in the sugar-pill group; the record does not provide a participant-flow account explaining these counts.

Single masking is recorded, but the identity of the masked parties is not reported in the registry record. Details of the randomization sequence, allocation concealment, adherence, treatment discontinuation, and follow-up are also not reported. A parallel-group design means the intended comparison was between separate groups assigned to different interventions, rather than a crossover in which participants receive both. In general, pilot studies may assess feasibility or provide preliminary information, but the registry does not state a sample-size justification or define the specific pilot objectives. The posted information does not establish that the planned primary comparison was carried out.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Serum samples were obtained and frozen but never analyzed to obtain isoprostane values due to PI departure from study center prior to any batches being sent for analysis.

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 Thiobarbituric Reactive Substances (TBARS), measured over baseline and after 12 weeks.

The primary endpoint is listed as Thiobarbituric Reactive Substances (TBARS), with no unit specified. The registry describes TBARS as a serum marker of oxidative stress and gives the timeframe as baseline and after 12 weeks. In general, a biomarker endpoint is used to measure a biological process that may be relevant to a condition or intervention. It is not, by itself, a direct measure of how participants feel, function, or experience clinical events.

The record's description of the primary outcome says that serum samples were obtained and frozen but never analyzed to obtain isoprostane values, because the principal investigator left the study center before any batches were sent for analysis. This wording does not match the named primary endpoint, TBARS. The registry does not clarify whether the same samples were intended for both measures or explain the difference in terminology. Consequently, there is no reported TBARS result, change from baseline, between-group contrast, or measure of precision. The record also does not report a unit or a detailed analysis definition for the endpoint. This missing analysis prevents interpretation of the intended primary biomarker comparison, regardless of the study's randomized design.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation depends on a defined outcome, an analysis population, a comparison, and an estimate with an indication of uncertainty. The registry identifies a primary marker and a measurement timeframe, but it reports that the samples were not analyzed. Consequently, no statistical method can recover a primary group comparison from the information in the registry record. The absence of a reported estimate is not a result showing no difference; it means that the intended outcome comparison is unavailable.

What randomization contributes

In general, randomization assigns participants to groups by chance. Its purpose is to make treatment groups comparable on average with respect to factors present before treatment, including factors that may not have been measured. This rationale applies to a study only if assignment was carried out as intended and the relevant outcome data are analyzed. Here, random allocation is recorded, but details about sequence generation, concealment, and implementation are not reported in the registry record. The missing primary outcome analysis means that the design feature cannot yield an estimated POMx-versus-sugar-pill effect in the posted results.

What masking does and does not tell us

The design is labeled single-masked. In general, masking can reduce the influence of knowledge about assigned treatment on behavior, outcome assessment, or reporting. The term alone does not identify who was masked. The registry record does not specify whether participants, clinicians, outcome assessors, or other study personnel were unaware of allocation. It also does not describe how masking was maintained or assessed. Those details should not be inferred from the label.

Why a defined estimand matters

In general, an estimand makes precise what treatment effect is being sought: the population, treatment conditions, outcome, timeframe, and handling of events such as discontinuation or missing measurements. The intended outcome is TBARS at baseline and after 12 weeks, but the registry does not state a detailed contrast, such as whether the primary analysis was intended to compare final values or changes from baseline. It also does not report how treatment discontinuation, nonadherence, or missing measurements would have been handled. Without those details and without analyzed measurements, the primary question cannot be translated into a reported effect estimate.

What a confidence interval would mean

In general, a confidence interval describes the uncertainty around an estimated effect under specified statistical assumptions. A narrower interval indicates greater precision, while a wider interval indicates less precision. It does not by itself determine whether an effect is important, and it cannot be interpreted without knowing the estimate and analysis. No interval is reported for TBARS or the listed secondary outcomes. Therefore, the precision of any group difference is also not reported.

Multiplicity and multiple outcomes

In general, testing several outcomes or several comparisons can increase the chance of obtaining a seemingly notable result by chance if each is interpreted independently. Statistical plans may address this by defining a primary endpoint, ordering tests, or adjusting inference. The registry lists one primary outcome and three secondary outcome categories, but a multiplicity strategy is not reported in the registry record. Since the record reports zero analyses, there are no posted outcome tests to interpret, adjusted or otherwise. The presence of multiple registered outcomes does not establish that each was measured or analyzed.

Planning illustrations are not observed power

In general, sample-size calculations describe the number of participants needed under assumptions about the target effect, variability, allocation, significance level, and analysis method. They are planning tools, not evidence that a study found an effect. The registry record does not report the trial's own sample-size justification. Any planning illustration based on an observed effect is distinct from the original design rationale and is not observed power. In this case, because the primary outcome was not analyzed, an observed primary effect is not available as a basis for interpreting such an illustration. The record's stated illustration assumptions include a two-sided significance level of 0.05, equal allocation, and a normal approximation, with effects expressed as fractions of an observed effect. Those assumptions do not document the trial's own analysis plan.

Finally, the record labels the study as terminated and reports no analyses. It does not report interim analyses, a statistical analysis plan, the methods used for any safety summaries, or procedures for handling missing data. These gaps limit what can be concluded about the intended methods and about the results. General statistical principles can explain what such methods would do, but cannot fill in unreported trial-specific decisions.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists TBARS as the primary outcome and names F-8 Isoprostanes, Procollagen Types I (PINP) and III (PIIINP), and Asymmetric Dimethylarginine (ADMA) as secondary outcomes. It reports four outcome measures and zero analyses. No outcome-specific results, estimates, or inferential tests are reported. The record does not state whether a multiplicity strategy was planned for the several outcomes or whether any hierarchy was specified. In general, accounting for multiple tests can help control the chance of false-positive interpretations when several findings are assessed, but no such procedure should be assumed.

The registry says serum samples were collected and frozen but never analyzed to obtain isoprostane values because the principal investigator departed before any batches were sent for analysis. That wording differs from the named primary TBARS endpoint. The record does not clarify whether the samples were intended to support both outcomes, or whether other secondary outcome samples were collected or analyzed.

Although the study is randomized, the registry does not identify an analysis population, such as all randomized participants or only those with available measurements. It does not report participant flow, the number with outcome measurements, treatment adherence, withdrawal, or how missing observations would have been handled. In general, missing outcome data can affect both the number of participants contributing to an analysis and the interpretation of a group comparison. Here, the central limitation is that the primary samples were not analyzed, so no missing-data method or analysis population can be evaluated. Reasons and patterns of missingness beyond the investigator departure are not reported in the registry record.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry's safety information lists 13 participants at risk in the POMx group and 7 in the sugar-pill group. For each group, the recorded counts are zero for serious adverse events, zero for other adverse events, and zero for deaths. These figures describe the registry's reported counts and denominators; they do not provide an estimate of comparative risk or a statistical test.

The counts at risk are not the same as the arm descriptions, which state that 15 subjects would be assigned to each group, or the overall enrollment figure of 20. The registry does not explain the difference or provide participant-flow details. It also does not define the event categories, state the safety observation period, or describe how events were collected. In general, a zero recorded count means that no event in that category was entered for the listed group and reporting scope. It does not establish that an event was impossible or that the study could rule out uncommon harms. The registry record does not report additional information needed to interpret the completeness of safety surveillance.

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

The registry record documents the intended comparison of POMx with a sugar pill in a randomized, single-masked, parallel-group pilot study involving chronic cardiomyopathy complicated by renal insufficiency. It identifies TBARS as the primary endpoint, describes it as a serum marker of oxidative stress, and gives baseline and after 12 weeks as the measurement timeframe. The record also lists three secondary outcome categories.

What it does not provide is an analyzed primary result. The serum samples were reportedly obtained and frozen, but were not analyzed, and the record states that no analyses were reported. There is therefore no reported estimate of the effect of POMx on TBARS, no comparison with the sugar-pill group, and no measure of uncertainty for the primary endpoint. This absence cannot be interpreted as evidence of no effect or as evidence of an effect. It is an absence of outcome analysis in the registry record.

The record also does not explain the mismatch between the named TBARS endpoint and the note about samples not being analyzed to obtain isoprostane values. Nor does it reconcile the enrollment figure, planned arm sizes, and safety denominators. These issues limit the ability to reconstruct who contributed data to the study or what outcome information may have been available.

The safety entries record zero serious adverse events, zero other adverse events, and zero deaths in both listed groups. Those entries should be interpreted within the reported group sizes and the limited information about event definitions and follow-up. They are not a substitute for the missing efficacy outcome analysis. Overall, the registry supports description of the study's design and reporting gaps, but not a conclusion about the primary biomarker comparison.

13. Why This Trial Matters Statistically

This trial is statistically notable because it separates the existence of a randomized design from the availability of analyzable results. Randomization is a method for supporting a fair comparison, but it cannot produce an effect estimate when the registered primary samples are not analyzed. The registry reports that samples were collected and frozen, while also stating that they were never analyzed after the principal investigator left the study center before batches were sent for analysis. The resulting gap is central to interpreting the study.

The record also illustrates why registered outcomes, planned enrollment, and analyzed populations should be distinguished. It lists enrollment of 20, describes 15 subjects in each planned arm, and reports safety denominators of 13 and 7. Without participant-flow information, those figures cannot be reconciled or treated as if they refer to the same group of participants. The registry's zero analysis count further means there is no posted outcome comparison to pair with the design description.

In general, precise reporting of outcome definitions, analysis populations, missing-data handling, and uncertainty helps readers assess how robust a trial's findings are. Here, the outcome wording itself is not fully aligned: TBARS is named as primary, while the note about unprocessed samples refers to isoprostane values. The registry does not resolve that difference. This makes clear that a stated endpoint and a documented analysis are separate parts of the evidence record.

The study therefore matters statistically as an example of the limits of inference when planned measurements do not lead to reported analyses. Its registry entry can inform readers about the intended question and the recorded safety counts, but cannot supply the missing primary effect estimate or its precision.

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 primary limitation is that the registry reports no analysis of the primary outcome samples. It says that serum samples were collected and frozen but never analyzed to obtain isoprostane values because the principal investigator departed from the study center before batches were sent for analysis. The named primary outcome is TBARS, so the record also contains an unresolved difference in outcome terminology. No primary result, group contrast, or uncertainty estimate is reported.

The record lists zero analyses despite naming four outcome measures. It does not give results for the secondary outcomes or explain whether they were measured, available, or analyzed. It also does not report a statistical analysis plan, interim analyses, a sample-size justification, or the approach to multiplicity.

Participant accounting is incomplete. The registry lists enrollment of 20, while the arm descriptions state 15 subjects in each group. Safety denominators are 13 and 7. The record does not provide a flow of participants from assignment through treatment and outcome measurement, nor does it explain the differences. The analysis population and handling of missing measurements are not reported.

Further design details are absent, including the randomization procedure, allocation concealment, which parties were masked, and how masking was maintained. The registry also does not report detailed eligibility criteria, baseline characteristics, adherence, reasons for withdrawal, or a fuller account of follow-up. For safety, event definitions and the observation period are not reported. These limitations restrict assessment of both the study's conduct and the meaning of its recorded counts.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study — NCT01102140.
• Registry record last updated 2017-07-14; status last verified 2017-06.
• Results first posted 2017-07-14.
• 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

NCT01102140 is a Phase 2 randomized, single-masked, parallel-group pilot study of POMx versus a sugar pill for chronic cardiomyopathy complicated by renal insufficiency. The record lists enrollment of 20, a terminated status, a start date of 2010-07, and a primary completion date of 2013-05-31. The arm descriptions specify 1000 mg of oral POMx or a matching sugar pill for 12 weeks.

TBARS is the named primary outcome, with measurements intended at baseline and after 12 weeks. The registry says samples were obtained and frozen but not analyzed, and records zero analyses. It lists F-8 Isoprostanes, PINP and PIIINP, and ADMA as secondary outcomes. Safety counts are zero for serious adverse events, other adverse events, and deaths in each group, with 13 and 7 participants at risk, respectively. The registry does not report a primary outcome estimate or reconcile its participant counts.