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 LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction (NCT00887588), a randomized phase 2 study. The primary outcome is Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00887588 |
| Phase | Phase 2 |
| Condition | Chronic Heart Failure |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 307 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Participants had chronic heart failure with preserved left-ventricular ejection fraction. The primary analysis included full-analysis-set participants who had both baseline and 12-week NT-proBNP values. The full analysis set was defined as randomized participants with a baseline and at least one post-baseline efficacy measurement during the double-blind period.
Intervention
Participants assigned to LCZ696 began at 50 mg, then were uptitrated to 100 mg twice daily and thereafter to 200 mg twice daily. Before randomization, participants had a single-blind placebo run-in.
Comparator
The active comparator was valsartan. Its regimen began at 40 mg twice daily, followed by uptitration to 80 mg twice daily and thereafter to 160 mg twice daily. The record lists placebo as an intervention, but reports the randomized arm results for LCZ696 and valsartan.
Primary question
The primary question was how NT-proBNP at 12 weeks compared with baseline in each treatment group. The endpoint was expressed as an endpoint-to-baseline ratio; a ratio < 1 indicates improvement. The registry record does not report a formal between-group primary comparison estimate or its statistical test.
The study was designed to assess effects of 36 weeks of treatment, while the posted primary endpoint is specifically the change from baseline at 12 weeks. That distinction matters: the primary result describes an early measurement, not the full 36-week treatment period. The posted secondary results include echocardiographic measures assessed at 36 weeks, so they address a different timeframe and different aspects of cardiac structure and function.
The central comparison is active treatment against active treatment, not against no treatment. Consequently, the group estimates describe changes during the study regimens and should not be read as estimates of either regimen against placebo. The presence of a placebo run-in does not make placebo the randomized comparator in the reported two-arm results.
3. Trial Design
This was a phase 2, randomized, double-blind, multicenter, parallel-group, active-controlled study. The registry record lists enrollment of 307 participants and identifies chronic heart failure as the condition. It lists Novartis Pharmaceuticals as sponsor. The study is marked completed; its recorded start was 2009-11 and primary completion was 2011-12.
Participants entered a single-blind placebo run-in, then were randomized to LCZ696 or valsartan for the double-blind treatment period. The treatment descriptions specify staged dose uptitration in both groups. The record’s title describes a 36-week study, and the primary endpoint timeframe gives baseline and 12 weeks. Secondary echocardiographic measures with posted results use a baseline-to-36-week timeframe.
Randomization supports a treatment-group comparison by reducing systematic differences at assignment, while double masking is intended to limit the influence of treatment knowledge on participants and study conduct. These design features do not by themselves establish that every reported analysis preserved the benefits of randomization: the primary analysis required both baseline and 12-week values, and the secondary results use endpoint-specific analysis counts.
The recorded enrollment and the analysis counts refer to different things. The primary endpoint includes participants meeting its stated analysis-population and measurement requirements, while safety figures use their own at-risk groups. These figures should not be merged or treated as interchangeable denominators. The registry record does not report details of the randomization sequence, allocation concealment, or the handling of participants who discontinued treatment.
The record lists 24 outcome measures and 23 secondary outcomes, but reports no analyses in its analysis count. Numerical results are nevertheless posted for the primary measure and for three secondary echocardiographic measures. No additional design rationale or sample-size justification is 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: Eight participants, who completed the core, could not continue in the extension because the 36 week protocol amendment was not yet approved by health authorities; 1 participant, who completed the core, discontinued before the extension start due to an adverse event.
Core Period
| Stage | LCZ696 | Valsartan |
|---|---|---|
| STARTED | 149 | 152 |
| Extension Efficacy Set | 127 | 125 |
| Full Analysis Set | 148 | 146 |
| Arterial Stiffness Set | 86 | 94 |
| COMPLETED | 130 | 131 |
| NOT COMPLETED | 19 | 21 |
Reasons for not completing this period:
| Reason | LCZ696 | Valsartan |
|---|---|---|
| Death | 1 | 1 |
| Lost to Follow-up | 3 | 1 |
| Withdrawal by Subject | 6 | 8 |
| Adverse Event | 9 | 11 |
Extension Period
| Stage | LCZ696 | Valsartan |
|---|---|---|
| STARTED | 127 | 125 |
| Arterial Stiffness Set | 86 | 94 |
| COMPLETED | 121 | 120 |
| NOT COMPLETED | 6 | 5 |
Reasons for not completing this period:
| Reason | LCZ696 | Valsartan |
|---|---|---|
| Adverse Event | 4 | 4 |
| Death | 0 | 1 |
| Protocol deviation | 1 | 0 |
| Lost to Follow-up | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Participants from the full analysis set (FAS), who had both baseline and 12 week values, were included in the analysis. The FAS consisted of all randomized participants who had baseline and at least one post-baseline efficacy measurement during the double blind 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.
| Characteristic | Unit | LCZ696 | Valsartan | Total |
|---|---|---|---|---|
| Participants analysed | 149 | 152 | 301 | |
| Age, Continuous | Years | 70.9 (SD 9.38) | 71.2 (SD 8.94) | 71.0 (SD 9.15) |
| Sex: Female, Male: Female | Participants | 85 | 85 | 170 |
| Sex: Female, Male: Male | Participants | 64 | 67 | 131 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP), measured over Baseline, 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | ratio: endpoint/baseline (pg/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change from baseline in N-terminal pro-brain natriuretic peptide, or NT-proBNP, measured by a central laboratory. The change is represented as the ratio of the 12-week value to the baseline value, in pg/mL. A ratio below 1 indicates that the measured value at 12 weeks is lower than at baseline, which the record defines as improvement.
The registry reports geometric means and 95% confidence intervals for the group ratios. A geometric mean is suited to positive measurements that are interpreted multiplicatively: it describes a typical proportional level rather than an arithmetic average of raw differences. This is consistent with expressing change as an endpoint-to-baseline ratio. The confidence interval conveys uncertainty around each group estimate; it is not itself a direct estimate of the difference between treatment groups.
NT-proBNP is used in this study as a laboratory measure related to heart failure and as the prespecified primary endpoint. The record describes an assessment of treatment effects on this measure, but does not report why this endpoint was selected in preference to other possible clinical or laboratory measures. Nor does the endpoint alone provide a complete account of symptoms, function, hospitalization, or other outcomes.
The primary timeframe is baseline to 12 weeks, even though the study title and treatment description refer to 36 weeks. The posted ratios therefore answer a time-specific question. They should not be treated as 36-week measurements or as evidence of a difference in long-term clinical outcomes.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For LCZ696, the posted primary geometric-mean ratio is 0.83, with a 95% confidence interval from 0.68 to 1.01. For valsartan, the ratio is 1.08, with a 95% confidence interval from 0.89 to 1.32. By the registry’s endpoint definition, a ratio below 1 indicates improvement. The group point estimates therefore lie on different sides of 1, but each interval includes 1. The estimates are compatible with a range of underlying values, and the intervals do not establish a clear within-group change relative to the baseline reference.
These are separate estimates for each treatment group. Their confidence intervals do not constitute a confidence interval for the treatment-group contrast, and comparing whether the individual intervals overlap is not a substitute for a direct statistical test. The registry record does not report a primary between-group estimate, confidence interval, or p-value. Accordingly, the posted primary results do not establish the size or precision of a treatment difference.
The primary analysis is also restricted to participants with both baseline and 12-week measurements within the defined full analysis set. This means that the result is not simply a summary of every randomized participant. If having a measurement at both time points is related to treatment response or health status, the analyzed groups could differ from the full randomized groups in ways that affect interpretation. The registry record does not report missing-data handling or a comparison of included and excluded participants.
The secondary echocardiographic results describe changes at 36 weeks. Their estimated group contrasts are small relative to their uncertainty, and the recalculated unadjusted confidence intervals include no difference. These analyses are secondary and several outcome measures are listed. In the absence of a reported multiplicity adjustment or a stated statistical analysis plan, isolated secondary findings would be less persuasive than a prespecified primary comparison. The registry record does not report a multiplicity procedure.
Safety counts are also descriptive. Serious adverse events were reported for 22 participants in the LCZ696 group and 30 in the valsartan group; other adverse events were reported for 79 and 92, respectively. These counts use safety groups of 149 and 152, not the primary endpoint analysis counts. They should not be interpreted as a tested comparative safety effect; no statistical comparison of adverse-event rates is reported in the registry record. Death counts are not reported in the registry record.
Overall, the posted data provide group-level estimates at defined time points, but not the formal primary treatment contrast needed to quantify comparative effect. They also do not establish that any secondary difference is confirmatory. The most defensible reading separates the endpoint ratios, secondary echocardiographic measures, and descriptive safety counts rather than treating them as interchangeable evidence.
9. Statistical Methods Explained
The primary measure is a ratio, not a raw difference in NT-proBNP. If the endpoint value is divided by the baseline value, a ratio of 1 represents no change on that multiplicative scale; a value below 1 represents a lower endpoint measurement than baseline. The registry explicitly states that a ratio < 1 indicates improvement. Because the measure is a ratio, geometric means are a natural summary: they describe a central value on a multiplicative scale and avoid treating proportional changes as if they were additive changes in the original units.
A confidence interval expresses uncertainty around an estimated quantity under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates less precision. For an endpoint-to-baseline ratio, an interval that includes 1 includes the no-change reference value. Both posted primary intervals include 1. This does not prove that there was no change; it means the estimates, with their reported uncertainty, do not rule out that reference value. The intervals are group-specific, so they cannot answer the separate question of whether the groups differ.
A between-group analysis would estimate a contrast between LCZ696 and valsartan, with uncertainty around that contrast and an associated test if reported. The registry gives group ratios and intervals but no direct primary contrast. Reconstructing a contrast from separate confidence intervals would require assumptions and would not replace the trial’s own analysis. The registry record does not report a primary comparison estimate or test.
The secondary continuous endpoints are reported as least-squares means with standard errors. A least-squares mean is a model-based mean, generally adjusted for terms in the fitted analysis; the registry record does not state which terms were used. A standard error describes the precision of an estimated mean, rather than the spread of individual participant measurements. It should not be interpreted as a standard deviation. The displayed secondary comparison calculations are labeled recalculated: they are simple, unadjusted re-calculations from posted summary statistics, not the sponsor’s reported model-based comparisons. The registry record does not report those sponsor analyses.
For a continuous outcome, a mean difference expresses the contrast on the outcome’s original scale. A confidence interval for a difference that includes zero is compatible with no difference, as well as with values in either direction. The recalculated results for the three posted echocardiographic outcomes have intervals spanning zero. Their unadjusted p-values are descriptive calculations, not reported sponsor tests. Such re-calculations may not reproduce a trial analysis that uses covariate adjustment, a different analysis population, or other model features. The registry record does not report enough detail to determine whether those features were used.
Standard errors can be used to estimate a standard deviation only under assumptions about the analysis and sample size. The secondary recalculations use an approximate standard deviation derived from the posted standard errors. That approximation permits an illustrative standardized effect calculation, but it is not an observed participant-level standard deviation and does not recover the original model. Small or imprecise estimated effects can lead to very large planning sample sizes when used as targets, so those figures should be understood as illustrations rather than as the trial’s design rationale.
The sample-size illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They consider detecting stated fractions of the observed effect and report participants per arm for the continuous outcomes. These are planning scenarios based on observed estimates; they are not observed power, and they do not show that the original study was designed around those estimates. The registry record does not report the trial’s own sample-size assumptions or justification.
Over-dispersion is a general issue in analyses of counts: it occurs when the variability is greater than a simple count model expects, potentially making standard errors too small if the model does not account for it. The posted primary endpoint is a continuous ratio and the available secondary comparisons are continuous measures, so over-dispersion is not the main issue for the calculations. For adverse-event counts, the registry does not report a comparative model or enough analysis detail to assess how count variability was handled.
Randomization and masking are design features, whereas the analysis population and missing-data approach are analytic choices. The primary population definition requires a baseline and at least one post-baseline efficacy measurement for inclusion in the full analysis set, and the primary result further requires both baseline and 12-week values. Such complete-measurement requirements can affect precision and can also create selection concerns if availability of measurements is related to outcome. The registry record does not report an imputation method, sensitivity analysis, or analysis of missingness.
Finally, multiple endpoints create a multiplicity issue. When many outcomes are examined, the chance of finding at least one apparently notable result by chance can increase. A prespecified hierarchy or adjustment can address this, but no such procedure is reported in the registry record. Thus, secondary results and unadjusted recalculations should be interpreted as exploratory rather than as a collection of independent confirmatory tests.
10. Multiplicity, Missing Data and Analysis Populations
The registry defines the primary analysis population as full-analysis-set participants with baseline and 12-week NT-proBNP values. The full analysis set itself consists of randomized participants with a baseline measurement and at least one post-baseline efficacy measurement during the double-blind period. The primary analysis therefore requires more than randomization alone: participants must also have the specified measurements available.
The record does not describe how missing baseline or 12-week values were handled, whether any values were imputed, or whether sensitivity analyses were conducted. It also does not report how many otherwise eligible participants lacked a measurement. Without this information, it is difficult to assess the potential impact of incomplete outcome data or whether the analyzed participants remained comparable across groups.
The registry lists 23 secondary outcomes, while the record includes numerical secondary results for three echocardiographic measures. It does not report a multiplicity adjustment, a prespecified testing hierarchy, or a statistical analysis plan explaining how these outcomes were to be interpreted. When multiple outcomes are examined, chance findings become more likely unless the analysis accounts for that multiplicity. This is why unadjusted secondary results should not be treated as if each were a standalone confirmatory test.
The record’s analysis count is zero, and no sponsor-reported secondary analyses are listed. This does not mean that the trial had no analyses; numerical outcome summaries are posted. It means the registry record does not provide reported analysis entries or enough methodological detail to establish the inferential procedures behind those results. The record also does not report interim analyses, stopping rules, or a sample-size justification. Those details should not be inferred from the completed status or the enrollment figure.
These omissions constrain interpretation, not merely documentation. They limit assessment of whether analyses followed a prespecified plan, how missing data affected estimates, and how multiple outcomes were handled. As a result, the posted findings support descriptive reading of the reported estimates, but not a complete audit of the trial’s inferential analysis.
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 |
|---|---|---|---|
| LCZ696 | 22 | 149 | 14.8% |
| Valsartan | 30 | 152 | 19.7% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| LCZ696 | 79 of 149 |
| Valsartan | 92 of 152 |
Most frequent serious adverse event terms
| Event term | Organ system | LCZ696 | Valsartan |
|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 2 of 149 | 4 of 152 |
| Cardiac failure | Cardiac disorders | 3 of 149 | 2 of 152 |
| Angina unstable | Cardiac disorders | 3 of 149 | 1 of 152 |
| Cardiac failure acute | Cardiac disorders | 1 of 149 | 3 of 152 |
| Anaemia | Blood and lymphatic system disorders | 2 of 149 | 1 of 152 |
| Angina pectoris | Cardiac disorders | 1 of 149 | 2 of 152 |
| Hyperkalaemia | Metabolism and nutrition disorders | 2 of 149 | 1 of 152 |
| Renal failure acute | Renal and urinary disorders | 2 of 149 | 1 of 152 |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 0 of 149 | 3 of 152 |
| Hypotension | Vascular disorders | 2 of 149 | 1 of 152 |
Most frequent non-serious adverse event terms
| Event term | Organ system | LCZ696 | Valsartan |
|---|---|---|---|
| Hypotension | Vascular disorders | 19 of 149 | 14 of 152 |
| Hyperkalaemia | Metabolism and nutrition disorders | 10 of 149 | 8 of 152 |
| Dizziness | Nervous system disorders | 11 of 149 | 7 of 152 |
| Asthenia | General disorders | 7 of 149 | 10 of 152 |
| Cough | Respiratory, thoracic and mediastinal disorders | 9 of 149 | 8 of 152 |
| Urinary tract infection | Infections and infestations | 6 of 149 | 9 of 152 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 4 of 149 | 11 of 152 |
| Diarrhoea | Gastrointestinal disorders | 9 of 149 | 4 of 152 |
| Oedema peripheral | General disorders | 4 of 149 | 9 of 152 |
| Atrial fibrillation | Cardiac disorders | 2 of 149 | 8 of 152 |
Serious events with the highest arm-level rate: dyspnoea (2.6%), angina unstable (2.0%), cardiac failure (2.0%), cardiac failure acute (2.0%), productive cough (2.0%).
The safety record reports serious adverse events for 22 participants in the LCZ696 group, among 149 at risk, and 30 participants in the valsartan group, among 152 at risk. Other adverse events are reported for 79 participants in the LCZ696 group and 92 in the valsartan group, using those same group-specific at-risk counts. These are descriptive counts; the registry record does not report a statistical comparison or an adjusted analysis of safety outcomes.
The record also lists serious adverse event terms and their reported percentages: dyspnoea, 2.6%; unstable angina, 2.0%; cardiac failure, 2.0%; acute cardiac failure, 2.0%; productive cough, 2.0%; and anaemia, 1.3%. These terms should be read as reported event summaries, not as estimates of comparative risk between groups. The registry record does not give enough detail to establish how repeated events or multiple terms per participant were handled.
Safety counts use a different population basis from the primary endpoint analysis counts. They should not be combined with, or substituted for, the efficacy denominators. Death counts are not reported in the registry record. Without reported comparative tests, follow-up detail, and fuller event-level information, these figures describe what was recorded but do not establish a comparative safety conclusion.
12. What the Result Does, and Does Not, Mean
The primary results show separate geometric-mean NT-proBNP ratios for LCZ696 and valsartan at 12 weeks. The LCZ696 point estimate is below the no-change reference of 1, while the valsartan point estimate is above it; each 95% confidence interval includes 1. This describes the posted group estimates and their uncertainty. It does not establish a direct treatment difference because the registry record does not report a primary between-group contrast.
The results do not show whether a difference between the regimens is clinically important. The registry record gives no threshold for a clinically meaningful NT-proBNP change and no primary comparative estimate. Nor does the primary endpoint by itself establish effects on symptoms, quality of life, hospitalization, survival, or other clinical outcomes.
The echocardiographic results are later measurements and are secondary. Their recalculated contrasts are imprecise and do not establish a clear difference. This should not be confused with proof that the treatments are equivalent or that no difference exists. Establishing equivalence or non-inferiority requires an appropriate design, margin, and analysis; such information is not reported in the registry record.
The safety figures are counts, not evidence from a reported comparative safety test. They do not show whether the observed differences are due to chance, nor do they provide a complete account of all safety considerations. The absence of reported death counts or fuller analysis detail limits what can be inferred from the safety record.
More broadly, the study’s randomized and double-blind design provides an important framework for comparing the active regimens, but interpretation also depends on the analysis population, missing data, outcome selection, and prespecified methods. Several of these details are not reported in the registry record. The posted evidence should therefore be understood as a set of outcome summaries with uncertainty, rather than as a complete account of comparative efficacy or safety.
13. Why This Trial Matters Statistically
This trial illustrates why the form of an endpoint matters. NT-proBNP is reported as an endpoint-to-baseline ratio and summarized with a geometric mean, whereas the secondary echocardiographic outcomes are reported as least-squares means. These summaries answer different statistical questions and use different scales. Interpreting them consistently requires attention to the measurement, reference value, analysis population, and timeframe rather than comparing the numbers as if they were interchangeable.
It also demonstrates the difference between a group estimate and a treatment contrast. The primary result includes an estimate and confidence interval for each arm, but no direct comparison estimate is reported. A reader cannot infer the precision of the treatment difference simply from the two individual intervals. This is a central statistical distinction: the clinical question is comparative, while the posted primary summaries are group-specific.
The record also shows why uncertainty should accompany effect estimates. The primary intervals include the no-change reference, and the secondary recalculated intervals include no difference. This is not proof of no effect; it indicates that the posted estimates do not pin down a precise direction or magnitude. Describing that uncertainty is more informative than treating a point estimate as definitive.
Finally, the case highlights the limits of registry reporting for secondary outcomes, missing data, multiplicity, and sample-size rationale. Recalculated planning illustrations can help show how estimates relate to future study planning, but they are not observed power and do not recreate the original design process. Clear separation of reported results, recalculations, and unreported methods is essential to sound interpretation.
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.
Several limitations specific to this record constrain interpretation. The primary endpoint is reported at 12 weeks, whereas the study title describes a 36-week treatment study. The available primary summaries therefore do not directly describe the endpoint at the end of the stated treatment period. The posted secondary echocardiographic outcomes use a 36-week timeframe, but they address different measures.
The primary record gives arm-level ratios and confidence intervals but not a direct between-group estimate or test. This leaves the principal comparative question unresolved by the posted primary statistics. The analysis population also requires observed baseline and follow-up measurements, while missing-data methods and the extent of missingness are not reported in the registry record.
For secondary outcomes, only a subset has numerical results available in the record, and the registry does not report the statistical plan or multiplicity handling. The comparisons described as recalculated are unadjusted calculations from summary statistics; they may not match the sponsor’s original model or analysis population. Standard deviations used in the planning illustrations are approximations derived from standard errors, adding another assumption to those calculations.
Safety outcomes are presented as counts without a reported comparative analysis, and death counts are not reported. The record does not provide enough detail to evaluate event timing, recurrent events, or the relationship between treatment discontinuation and adverse events. In addition, the recorded enrollment should not be mistaken for the number contributing to every outcome: analysis-specific counts differ, and the record does not explain all reasons for those differences.
These limitations do not erase the value of the posted summaries, but they narrow the conclusions they can support. They particularly limit claims about the primary treatment contrast, the robustness of secondary findings, and comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction — NCT00887588.
- Registry record last updated 2015-08-25; status last verified 2015-08.
- Results first posted 2015-08-13.
- 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
NCT00887588 is a completed phase 2 randomized, double-blind, parallel-group, active-controlled study of LCZ696 versus valsartan in chronic heart failure with preserved left-ventricular ejection fraction. The registry lists enrollment of 307 participants and a 36-week study. The primary endpoint is the baseline-to-12-week NT-proBNP ratio, summarized by group as a geometric mean with a 95% confidence interval.
The posted primary estimates are 0.83 for LCZ696 and 1.08 for valsartan; both confidence intervals include 1. The registry record does not report a direct primary between-group estimate or test. Numerical secondary results are available for three 36-week echocardiographic measures, with comparisons recalculated from posted summaries. Safety counts are descriptive, and comparative safety analyses and death counts are not reported in the registry record.