HypertensionRandomised controlled trial
Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial
- Randomised controlled trial
- prospective
- multicentre
- patient- and outcome-assessor-blinded
- sham-controlled
Authors' conclusion
In this trial of Chinese patients with uncontrolled hypertension on a standardized triple pharmacotherapy, RDN was safe and reduced ambulatory and office BP at 6 months compared with sham.
Study context
- Population
- Chinese patients with uncontrolled hypertension on standardized triple antihypertensive therapy
- Participants
- 217 patients
- Comparison
- Radiofrequency renal denervation (RDN) vs sham procedure
- RDNn = 107
- Shamn = 110reference
- Primary endpoint
- Between-group difference in baseline-adjusted change in mean 24-hour ambulatory SBP
- Follow-up
- 6 months
Primary result
24-hour ambulatory SBP change
Baseline-adjusted between-group difference
−9.4 mm Hg
95% CI −12.8 to −5.9
P < 0.001
By group
RDN
−13.0
± 12.1 · mm Hg
Sham
−3.0
± 13.0 · mm Hg
RDN vs Sham
baseline-adjusted between-group difference −9.4 mm Hg (95% CI −12.8 to −5.9); P < 0.001
As reported in the abstract
Further findings
| Outcome | difference (mm Hg) (95% CI) | P value | |
|---|---|---|---|
| 24-hour DBP · 6 months | −5.0 (−7.5 to −2.4) | P < 0.001 | |
| Office SBP | −6.4 (−10.5 to −2.3) | P = 0.003 | |
| Office DBP | −5.1 (−8.2 to −2.0) | P = 0.001 | |
| −15−10−505Difference, mm Hg (linear scale) |
Safety
| Outcome | RDN | Sham |
|---|---|---|
| Access site complication (hematoma) · through follow-up | 1 events | Not reported in the abstract |
Access site complication (hematoma) · through follow-up
- Resolved without sequelae; no other major device- or procedure-related safety events
Original publication
Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial. Circulation. Published 4 September 2024. doi:10.1161/circulationaha.124.069215
Summarised from the published abstract; every number is checked against it