This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical results on this page are limited to the ClinicalTrials.gov record.
1. Trial at a Glance
SPYRAL HTN-ON MED was a randomized, parallel-group, single-masked clinical trial evaluating renal denervation with the Symplicity Spyral™ multi-electrode renal denervation system against a sham procedure in hypertension. The registry identifies superiority as the hypothesis type and reports one formal statistical analysis, a two-sided t-test comparing change in office systolic blood pressure to 6 months.
| Feature | SPYRAL HTN-ON MED |
|---|---|
| Trial name | SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System |
| Therapeutic area | Cardiovascular |
| Conditions | Hypertension; Vascular Diseases; Cardiovascular Diseases |
| Phase | NA |
| Status | COMPLETED |
| Allocation | RANDOMIZED |
| Design model | PARALLEL |
| Masking | SINGLE |
| Primary purpose | TREATMENT |
| Enrollment | 337 |
| Lead sponsor | Medtronic Vascular |
| Sponsor type | INDUSTRY |
| Results posted | Yes |
| Statistical analyses posted | 1 |
| Registered primary endpoints | 2 |
2. Clinical Question
The clinical question is whether renal denervation using the Symplicity Spyral™ multi-electrode renal denervation system produces a difference in blood pressure outcomes compared with a sham procedure in participants with hypertension, while also evaluating the incidence of major adverse events.
Population
Participants enrolled in the SPYRAL HTN-ON MED study under the registry's conditions of hypertension, vascular diseases, and cardiovascular diseases.
Intervention
Symplicity Spyral™ multi-electrode renal denervation system.
Comparator
Sham Procedure.
Primary questions
Does renal denervation change systolic blood pressure measured by 24-hour ABPM from baseline to 6 months, and what is the incidence of major adverse events over the registered safety time frame?
3. Trial Design
Symplicity Spyral™ system
- Symplicity Spyral™ multi-electrode renal denervation system
- Renal denervation intervention
- Evaluated against the sham procedure
Sham procedure
- Sham Procedure
- Parallel randomized comparator
- Used as the reference group for the reported between-group t-test
The registry describes a two-arm randomized parallel design with single masking. Because randomization creates the basis for a between-group causal comparison, the principal statistical question is whether the observed difference between renal denervation and sham groups is larger than would reasonably be expected from sampling variation under a null hypothesis of no difference.
4. Trial Timeline and Registry Status
Study start
The registry reports a study start date of July 22, 2015.
Primary completion
The registry reports primary completion on August 18, 2022.
Registry status
The study is listed as COMPLETED, with results posted on ClinicalTrials.gov.
5. Endpoints
The registry identifies two primary endpoints. One is a continuous blood-pressure endpoint measured by 24-hour ambulatory blood pressure monitoring; the other is a binary safety endpoint based on the incidence of major adverse events.
| Endpoint | Registry definition | Time frame | Type |
|---|---|---|---|
| Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) | Baseline adjusted change (using Analysis of Covariance) in systolic blood pressure (SBP) from baseline (Screening Visit 2) to 6 months post-procedure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM). | From baseline to 6 months post-procedure | Other / unclear |
| Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events | The Primary safety endpoint is the incidence of Major Adverse Events (MAE), defined as a composite including all-cause mortality, End stage renal Disease (ESRD), significant embolic event resulting in end-organ damage, renal artery perforation requiring intervention, renal artery dissection requiring intervention, vascular complications, hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol, New renal artery stenosis >70%, confirmed by angiography and as determined by the angiographic core laboratory, through one-month post-randomization (6-months for new renal artery stenosis) | From baseline to 1 month post-procedure (6 months for new renal artery stenosis) | Binary |
6. Primary Endpoint: What Was Prespecified?
Blood-pressure endpoint
The primary blood-pressure endpoint concerns baseline-adjusted change in systolic blood pressure from Screening Visit 2 to 6 months, measured by 24-hour ABPM.
Safety endpoint
The primary safety endpoint concerns the incidence of major adverse events from baseline through 1 month post-procedure, with 6 months specified for new renal artery stenosis.
Endpoint structure
The registry classifies the two primary endpoint types as Other / unclear and Binary, respectively.
Formal analysis available
The ClinicalTrials.gov record contains one posted statistical analysis, and it is for the secondary endpoint of change in office systolic blood pressure to 6 months.
This distinction matters. The fact that ClinicalTrials.gov reports results for the two primary endpoints does not mean that the ClinicalTrials.gov record contains formal effect estimates, confidence intervals, or P-values for those primary endpoints. The only formal statistical comparison reported here is the two-sided t-test for the secondary office systolic blood-pressure endpoint.
7. Planned Analysis of the Primary Blood-Pressure Endpoint
The registered definition specifies a baseline-adjusted change in systolic blood pressure from Screening Visit 2 to 6 months post-procedure, measured using 24-hour ABPM, and explicitly states that the adjustment is performed using Analysis of Covariance (ANCOVA).
The essential idea is to compare treatment groups at follow-up while accounting for baseline SBP. Baseline adjustment can improve precision because participants who begin the study with different blood-pressure values are compared conditional on their starting measurements.
For a continuous endpoint such as change in SBP, an ANCOVA treatment coefficient represents an adjusted between-group difference in the outcome. The ClinicalTrials.gov record does not provide the estimated adjusted difference, its confidence interval, or its P-value for this primary endpoint. Accordingly, no numerical primary blood-pressure treatment effect is reported here.
8. Planned Analysis of the Primary Safety Endpoint
The primary safety endpoint is binary: the incidence of Major Adverse Events (MAE) over the specified acute and chronic safety time frame. A binary endpoint is ordinarily summarized using the number and proportion of participants experiencing at least one event, followed where appropriate by a between-group comparison using a risk difference, risk ratio, odds ratio, or another prespecified binary-outcome method.
| Feature | Registry information reported |
|---|---|
| Endpoint | Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events |
| Type | Binary |
| Time frame | From baseline to 1 month post-procedure (6 months for new renal artery stenosis) |
| Composite | Major Adverse Events, with the registry-reported definition beginning with all-cause mortality, ESRD, significant embolic events, renal artery perforation or dissection requiring intervention, and vascular complications |
| Formal effect estimate reported | None in the posted results record provided |
The registry does provide serious adverse-event counts by arm, but serious adverse events are not interchangeable with the registered primary MAE endpoint. A serious adverse-event count should therefore be presented as its own safety measure rather than relabeled as the primary endpoint.
9. Results
Primary Endpoint Results: Registry Reporting Versus Formal Statistical Analysis
Results are posted for both registered primary endpoints. However, the posted statistical analyses contain only one formal analysis, and that analysis is designated Secondary. It evaluates change in office systolic blood pressure to 6 months using a two-sided t-test.
| Endpoint | Results posted | Formal statistical analysis reported | What can be reported |
|---|---|---|---|
| Change in Systolic Blood Pressure as Measured by 24-hour ABPM | Yes | No formal comparison reported | Registered definition, time frame, and planned ANCOVA approach |
| Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events | Yes | No formal comparison reported | Registered definition, time frame, and available arm-level safety information |
Secondary Endpoint: Change in Office Systolic Blood Pressure to 6 Months
Two-sided t-test
Groups compared: Renal Denervation vs Sham Procedure
Outcome unit: mmHg · Time frame: baseline to 6 months post-procedure
| Feature | Reported analysis |
|---|---|
| Outcome measure | Change in Office Systolic Blood Pressure to 6-months |
| Endpoint role | Secondary |
| Endpoint type | Continuous |
| Outcome unit | mmHg |
| Analysis population | Valid readings at time of data collection |
| Groups compared | Renal Denervation vs Sham Procedure |
| Method | t-test, 2 sided |
| Hypothesis type | Superiority |
| P-value | 0.002 |
The reported P-value of 0.002 indicates that the observed comparison in change in office systolic blood pressure was statistically incompatible with a null hypothesis of no between-group difference at the 0.002 level under the reported two-sided t-test framework.
The P-value does not tell us the magnitude of the treatment effect. It does not tell us how many mmHg separated the groups, because the ClinicalTrials.gov record does not provide the group means, mean difference, standard error, or confidence interval.
The P-value also does not represent the probability that the null hypothesis is true. It is a probability calculated under the specified null model, describing how unusual results at least as incompatible with that model would be if the null hypothesis were true.
Because the analysis population is defined as participants with valid readings at the time of data collection, the reported comparison is not described in the ClinicalTrials.gov record as an all-randomized-participant analysis. That distinction matters because exclusion of participants with missing or invalid measurements can change the population represented by the estimate.
Finally, this is a secondary endpoint. The ClinicalTrials.gov record identifies the hypothesis type as superiority, but it does not provide a multiplicity-adjustment scheme for this particular secondary comparison. Therefore, the P-value should not automatically be interpreted as establishing an independently controlled confirmatory finding unless the broader prespecified statistical-analysis plan establishes such control.
10. Why a t-test Was Used for the Reported Secondary Analysis
The reported secondary outcome is a continuous variable: change in office systolic blood pressure, measured in mmHg. The statistical-analysis record specifies a two-sided t-test comparing the renal-denervation and sham groups.
The numerator represents the observed difference between group means, while the denominator expresses the uncertainty of that difference. The resulting statistic is compared with a reference t distribution under the null hypothesis of no mean difference.
The exact computational form depends on the assumptions and implementation used by the analysis. The registry field reports only “t-test, 2 sided”; it does not specify whether an equal-variance or Welch formulation was used, nor does it provide the underlying group summaries.
Why continuous outcomes fit a t-test
Blood pressure is measured numerically, and the analysis concerns change in the measured value. A t-test directly addresses whether two group means differ.
Why two-sided matters
A two-sided test evaluates departures from the null in either direction rather than restricting the statistical alternative to one prespecified direction.
What the t-test does not provide by itself
The P-value alone does not quantify clinical magnitude. A mean difference and confidence interval are needed to describe magnitude and precision.
Why baseline adjustment is different
The primary ABPM endpoint is explicitly defined using ANCOVA, whereas the reported secondary office-SBP analysis is explicitly reported as a t-test.
11. Statistical Methodology
Analysis of Covariance for the Primary ABPM Endpoint
The registry definition for the primary blood-pressure endpoint explicitly specifies a baseline-adjusted change using Analysis of Covariance. ANCOVA combines a treatment-group comparison with adjustment for a continuous baseline measurement.
The treatment term represents the adjusted difference between randomized groups after accounting for baseline systolic blood pressure. The exact fitted model, covariance assumptions, and estimation details are not provided in the ClinicalTrials.gov record.
Two-Sided t-Test for the Secondary Endpoint
The only formal statistical analysis in the ClinicalTrials.gov record is a two-sided t-test for change in office systolic blood pressure to 6 months. The comparison is between the renal-denervation and sham groups and uses the analysis population defined as valid readings at the time of data collection.
Superiority Hypothesis
The registry identifies the hypothesis type as Superiority. In a superiority framework, the null hypothesis generally represents no treatment difference, while the alternative permits a difference between groups. The reported secondary analysis is two-sided, so departures from equality in either direction are considered by the test.
Randomization
Randomization is the design feature that makes the treatment-group comparison informative about causal treatment effects under the assumptions of the trial. Rather than assigning treatment according to baseline characteristics or participant choice, participants are allocated through a randomized process. The ClinicalTrials.gov record identifies the allocation as RANDOMIZED but does not provide a randomization ratio or stratification factors.
Analysis Population
The reported t-test uses “Valid readings at time of data collection” as its analysis population. This wording is important because it indicates that the formal analysis is based on measurements meeting the analysis's validity criterion rather than simply stating that every enrolled participant was included.
12. Statistical Methods Explained
Why was a t-test used for the office blood-pressure endpoint?
The reported secondary endpoint is a continuous change in office systolic blood pressure measured in mmHg. A two-sample t-test is designed to compare the means of a continuous outcome between two groups. Here, those groups are renal denervation and sham procedure.
What does P = 0.002 mean?
Under the null hypothesis represented by the reported two-sided t-test, a P-value of 0.002 quantifies the probability of obtaining a result at least as incompatible with the null as the observed result, according to the test's reference distribution. It is evidence against that null model, not a measure of effect size.
Why is a two-sided test important?
A two-sided test allows the observed group difference to be evaluated in either direction. It therefore does not define statistical significance only through a prespecified beneficial direction. The registry-reported analysis is explicitly reported as “t-test, 2 sided.”
Why was ANCOVA specified for the primary ABPM endpoint?
The registry defines the primary endpoint as a baseline-adjusted change and explicitly identifies ANCOVA as the method for that adjustment. Conceptually, ANCOVA improves the comparison by accounting for baseline SBP while estimating the treatment-group difference at follow-up. The ClinicalTrials.gov record does not provide the exact fitted model or coefficient estimate.
Why does the analysis population matter?
The secondary analysis uses participants with “Valid readings at time of data collection.” If participants with missing or invalid measurements are excluded, the analyzed sample can differ from the randomized population. That can affect precision and, depending on the missingness mechanism, potentially affect the interpretation of the comparison.
Why should the P-value not be treated as an effect size?
A P-value depends on both the magnitude of the observed difference and the amount of information available to estimate it. A small P-value can accompany a modest effect in a sufficiently informative study, while a clinically meaningful effect can produce a less extreme P-value when uncertainty is large. The effect estimate and confidence interval are therefore essential complements to a P-value.
13. Confidence Intervals and Effect-Size Reporting
A complete continuous-outcome analysis normally benefits from reporting the estimated between-group mean difference together with a confidence interval. That combination answers two different questions: how large the estimated difference is and how precisely it has been estimated.
Effect estimate
For a blood-pressure comparison, the natural effect measure is a difference in mean change, expressed in mmHg.
Confidence interval
A confidence interval describes statistical uncertainty around the estimated treatment difference under the specified inferential framework.
P-value
The reported P = 0.002 addresses evidence against the null hypothesis but does not communicate the size of the blood-pressure difference.
Clinical scale
Because the outcome is expressed in mmHg, the numerical magnitude of the estimated difference is needed to understand its scale. That estimate is not reported in the ClinicalTrials.gov record.
14. Safety Results
The ClinicalTrials.gov record provides serious adverse-event counts by randomized arm. These counts should be distinguished from the registered primary Major Adverse Events composite because the two concepts are not defined as identical in the ClinicalTrials.gov record.
| Safety measure | Renal Denervation | Sham Procedure |
|---|---|---|
| Serious adverse events, affected / at risk | 51 / 206 | 26 / 131 |
The denominators reported with the safety data are 206 for renal denervation and 131 for sham procedure. The record does not provide a formal statistical comparison, confidence interval, or P-value for these serious-adverse-event counts. It also does not identify these counts as the registered primary MAE endpoint.
The safety counts show the number of affected participants and the number at risk in each arm. They do not by themselves establish a causal difference in safety between the randomized groups. Formal comparison would require a prespecified definition of the safety estimand, appropriate handling of follow-up time and event definitions, and a statistical method consistent with the endpoint.
It is particularly important not to substitute “serious adverse events” for the registered MAE composite. The primary safety endpoint has its own composite definition and time frame. A serious-adverse-event summary can therefore be informative while still answering a different question.
15. Primary Safety Endpoint Versus Serious Adverse Events
| Characteristic | Primary MAE endpoint | Serious adverse-event data reported |
|---|---|---|
| Role | Registered primary endpoint | Separate safety measure reported in ClinicalTrials.gov record |
| Type | Binary | Arm-level affected / at-risk count |
| Time frame | Baseline to 1 month post-procedure, with 6 months for new renal artery stenosis | Not specified in the registry-reported safety-count field |
| Composite definition | Specified as a composite of major adverse events | Not identified as the same composite |
| Formal comparison reported | No statistical analysis reported | No statistical analysis reported |
This distinction is a useful example of why clinical-trial statistical analysis begins with the exact endpoint definition. Two outcomes can both concern safety while having different event definitions, observation periods, estimands, and appropriate statistical analyses.
16. What the Reported P-value Does — and Does Not — Mean
The reported P = 0.002 comes from a two-sided t-test comparing change in office systolic blood pressure between the renal-denervation and sham groups at 6 months. Under the null hypothesis of no mean difference and the assumptions of the reported test, the result is relatively unlikely.
It does not mean there is a 0.2% probability that the treatment has no effect. Nor does it mean that the treatment effect is 99.8% certain, because frequentist P-values do not have that interpretation.
The ClinicalTrials.gov record does not provide the mean change in either arm or the between-group difference. Therefore, the P-value alone cannot tell the reader whether the observed difference was small or large in mmHg.
A confidence interval would show the precision of the estimated between-group difference. Without it, the registry-reported statistical result provides evidence against the null hypothesis but does not provide the same direct information about the plausible magnitude of the effect.
17. Statistical Interpretation Versus Clinical Interpretation
Statistical interpretation
The registry-reported secondary analysis reports a two-sided t-test with P = 0.002 for change in office systolic blood pressure to 6 months between renal denervation and sham procedure groups.
Clinical interpretation
The magnitude of the blood-pressure difference is necessary to describe the clinical scale of the observed effect. That numerical difference is not included in the ClinicalTrials.gov record.
Keeping these statements separate prevents a common analytical error: translating statistical evidence directly into a claim about clinical magnitude. Statistical significance and clinical importance are related but distinct dimensions of an evidence assessment.
18. Randomization and Causal Interpretation
The trial's RANDOMIZED allocation is central to its statistical interpretation. In a randomized comparison, the treatment assignment process is intended to make systematic baseline differences less predictable between groups. This provides the foundation for interpreting an appropriately conducted between-group comparison as evidence about the effect of the assigned intervention.
The purpose of inferential statistics is to quantify how compatible the observed difference is with a null treatment effect under the model and design. Randomization addresses allocation; statistical analysis addresses estimation and uncertainty.
Randomization does not eliminate every source of uncertainty. Missing observations, measurement validity, protocol deviations, analysis-population definitions, and endpoint construction can still affect the interpretation of the observed data. The ClinicalTrials.gov record specifically identifies “Valid readings at time of data collection” as the population for the reported secondary t-test.
19. Analysis Population and Missing Data
The formal secondary analysis is based on Valid readings at time of data collection. This phrase should be preserved because it defines which observations contributed to the reported comparison.
| Question | What the ClinicalTrials.gov record establishes |
|---|---|
| Was the study randomized? | Yes. |
| What population was used for the secondary t-test? | Valid readings at time of data collection. |
| Was an imputation method reported? | Not in the ClinicalTrials.gov record. |
| Was a missing-data sensitivity analysis reported? | Not in the ClinicalTrials.gov record. |
| Was the primary ABPM analysis specified as baseline-adjusted? | Yes, using ANCOVA. |
The absence of an imputation method in the ClinicalTrials.gov record should not be interpreted as evidence that no missing-data procedure existed. It means only that the ClinicalTrials.gov record does not specify one.
20. Multiplicity and Multiple Endpoints
The registry identifies 2 primary endpoints and also contains a separately reported secondary statistical analysis. Multiple endpoints create an important interpretive issue because testing several hypotheses can increase the chance of obtaining at least one small P-value by chance if no error-control strategy is applied.
Primary endpoints
The trial has two registered primary endpoints: a blood-pressure endpoint and a major-adverse-event safety endpoint.
Secondary analysis
The reported t-test concerns change in office systolic blood pressure and is explicitly classified as Secondary.
Multiplicity information
The ClinicalTrials.gov record does not provide an alpha-allocation or multiplicity-adjustment procedure for the posted secondary P-value.
Interpretive consequence
The P = 0.002 result should be described as the reported secondary analysis rather than silently promoted to a primary confirmatory result.
21. Non-Inferiority, Crossover, Factorial, Bayesian, and Interim-Analysis Topics
The ClinicalTrials.gov record identifies the hypothesis type as Superiority. They do not provide a non-inferiority margin, crossover design, factorial design, Bayesian analysis, or interim-analysis specification.
| Design topic | Information in the ClinicalTrials.gov record |
|---|---|
| Superiority | Yes — hypothesis type is Superiority. |
| Non-inferiority margin | Not provided. |
| Crossover | Not provided. |
| Factorial design | Not provided; design model is PARALLEL. |
| Multiplicity procedure | Not provided. |
| Interim analysis | Not provided. |
| Missing-data / imputation method | Not provided. |
| Bayesian methods | Not provided. |
| Stratification factors | Not provided. |
These omissions are analytically important. A statistical analysis should not infer an interim-monitoring scheme, Bayesian prior, non-inferiority margin, or multiplicity procedure simply because such methods are common in other clinical trials.
22. Limitations
- Primary effect estimates are not reported: although results are posted for the two registered primary endpoints, the ClinicalTrials.gov record does not provide formal numerical effect estimates, confidence intervals, or P-values for those primary endpoints.
- One formal analysis is available: the only registry-reported statistical analysis is a secondary two-sided t-test for change in office systolic blood pressure to 6 months.
- Effect size is missing for the secondary analysis: P = 0.002 is reported, but the corresponding mean difference and confidence interval are not reported.
- Analysis population: the secondary analysis uses participants with valid readings at the time of data collection, so it should not automatically be described as an all-randomized-participant analysis.
- Missing-data methods: the ClinicalTrials.gov record does not specify imputation or sensitivity-analysis procedures.
- Multiplicity: the trial has two registered primary endpoints and a reported secondary analysis, but the ClinicalTrials.gov record does not describe the multiplicity-control strategy for the secondary P-value.
- Safety endpoint definition:
- Safety comparison: serious-adverse-event counts are reported by arm, but no formal comparison is reported and the counts should not be substituted for the registered MAE endpoint.
- Generalizability: the ClinicalTrials.gov record does not provide the detailed eligibility, baseline-characteristic, or site-level information needed to assess how closely the enrolled population represents a broader clinical population.
- Method detail: the registry reports “t-test, 2 sided” but does not specify the exact t-test formulation or all underlying assumptions.
23. Why This Trial Matters Statistically
SPYRAL HTN-ON MED is a useful teaching case because it demonstrates how different layers of a randomized trial's statistical story fit together. The design is randomized and parallel, the primary efficacy endpoint is a continuous baseline-adjusted blood-pressure measure, the primary safety endpoint is binary, and the posted formal statistical analysis uses a two-sided t-test for a secondary continuous outcome.
| Concept | How it appears in SPYRAL HTN-ON MED |
|---|---|
| Randomization | The registry identifies allocation as RANDOMIZED. |
| Parallel-group design | The design model is PARALLEL with 2 arms. |
| Superiority testing | The hypothesis type is Superiority. |
| Continuous endpoint | Change in systolic blood pressure is measured in mmHg. |
| ANCOVA | The registered primary ABPM endpoint specifies baseline adjustment using Analysis of Covariance. |
| t-test | The posted statistical analysis uses a two-sided t-test for change in office systolic blood pressure. |
| P-value | The secondary analysis reports P = 0.002. |
| Analysis population | The secondary analysis uses valid readings at the time of data collection. |
| Binary safety endpoint | The primary MAE endpoint is classified as Binary. |
| Safety interpretation | Serious adverse events are reported as affected / at-risk counts by arm. |
| Multiplicity | Two primary endpoints are registered, while the registry-reported formal statistical analysis is secondary. |
| Reporting discipline | The distinction between posted outcomes and posted formal statistical analyses prevents unsupported effect estimates from being presented as registry results. |
24. Statistical Concepts in This Trial
Learn more about the methods used in this trial:
25. Related Statistical Calculators
26. Sources
- ClinicalTrials.gov: NCT02439775 — SPYRAL HTN-ON MED.
- Related PubMed record: PubMed 42294771.
- Related PubMed record: PubMed 40391448.
- Related PubMed record: PubMed 39526682.
- Related PubMed record: PubMed 38314554.
- Related PubMed record: PubMed 37914510.
Continue with Clinical Biostats statistical methods
Explore the statistical concepts that connect randomized clinical-trial design, continuous outcomes, hypothesis testing, and P-value interpretation.
27. Record Summary
SPYRAL HTN-ON MED provides a useful example of how to distinguish a trial's registered endpoints from the subset of statistical analyses that are explicitly reported. The study enrolled 337 participants in a randomized, parallel, single-masked design comparing renal denervation with a sham procedure. Its two registered primary endpoints address baseline-adjusted change in systolic blood pressure measured by 24-hour ABPM and the incidence of major adverse events.
The primary ABPM endpoint is defined using ANCOVA, while the registry-reported formal statistical-analysis record contains one two-sided t-test for the secondary endpoint of change in office systolic blood pressure to 6 months. That analysis reports P = 0.002 and uses the population with valid readings at the time of data collection. The P-value provides evidence against the corresponding null hypothesis, but the ClinicalTrials.gov record does not provide the numerical treatment difference or confidence interval needed to describe its magnitude and precision.
The safety data in the ClinicalTrials.gov record show serious adverse events affecting 51 of 206 participants in the renal-denervation arm and 26 of 131 in the sham-procedure arm. Those figures should be kept distinct from the registered Major Adverse Events composite, which has its own definition and time frame.