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SIMPLICITY HTN-3
A Controlled Trial of Renal Denervation
for Resistant Hypertension
Bhatt DL, Kandzari DE, O’Neill WW et al; SYMPLICITY HTN-3 Investigators
NEJM. 2014.
Symplicity HTN-3 Trial:
Overview
 Design
•
Multicenter (60 sites in the United States), prospective, randomized, blinded,
controlled study
 Population
•
530 patients with treatment-resistant hypertension
 Treatment
•
•
Treatment group (endovascular catheter-based RDN with the Symplicity® Renal
Denervation System™ plus baseline antihypertensive medications)
Control group (sham procedure plus baseline antihypertensive medications)
 Primary Outcome Measures
•
•
Change in office SBP from baseline to 6 months
Safety
Symplicity HTN-3 Trial:
Study Design
2 weeks
1M 3M
Treatment
2 weeks
Initial
screening
Home BP &
med Diary
Confirmatory
screening
ABPM
6M
Home BP & med
confirmation
Primary
end point
Renal
angiogram
2 weeks
Control
Home BP & med
confirmation
1M 3M
Abbreviations: ABPM, ambulatory blood pressure monitor; BP, blood pressure.
6M
1236M
•
Patient and research staff assessing BP
are blinded to treatment status.
•
No changes in medications for 6 months.
Symplicity HTN-3 Trial: Results
Primary efficacy end point
A significant change from baseline to 6
months in office systolic blood pressure was
observed in both study groups.
But the between-group difference did not
meet a test of superiority.
Symplicity HTN-3 Trial: Results
Secondary efficacy end point
A significant change from baseline to 6
months in ambulatory 24-hour average
systolic blood pressure was observed in
both groups.
But the between-group difference did not
meet a test of superiority.
Conclusion & limitations
• Denervation works: reduction in BP, heart rate, and LV mass.
• Renal denervation is safe.
• BP results heterogeneous: from excellent results to no effect.
Some reasons for heterogeneity of BP effect in clinical trials:
1.
2.
3.
4.
Inconsistent operator technique/catheter design issues.
Variable renal artery and nerve anatomy/accessibility of renal nerves.
Variable importance of sympathetic mechanisms in resistant HTN.
Effects confounded by major and frequent medication changes.