Randomised controlled trial
Effect of Alcohol-Mediated Renal Denervation on Blood Pressure in the Presence of Antihypertensive Medications: Primary Results From the TARGET Blood Pressure (BP) I Randomized Clinical Trial
- Randomised controlled trial
- prospective
- international
- sham-controlled
- patient- and assessor-blinded
Authors' conclusion
Alcohol-mediated RDN was associated with a modest but statistically significant reduction in 24-hour ambulatory SBP compared with sham control. No significant differences between groups in office BP or 6-month major adverse events were observed.
Study context
- Population
- Patients with uncontrolled hypertension (office systolic BP (SBP) ≥150 and ≤180 mm Hg, office DBP ≥90 mm Hg, 24-h ambulatory SBP ≥135 and ≤170 mm Hg) despite 2 to 5 antihypertensive medicationsrandomized 1:1
- Participants
- 301 patients
- Comparison
- Alcohol-mediated renal denervation (RDN) vs sham control
- Primary endpoint
- Baseline-adjusted change in mean 24-hour ambulatory SBP
- Follow-up
- 3 months after the procedure
Primary result
Change in 24-hour ambulatory SBP · 3 months
Treatment difference
−3.2 mm Hg
95% CI −6.3 to 0.0
P = 0.0487
By group
RDN
−10.0
mean · SD 14.2 · mm Hg
Sham
−6.8
mean · SD 12.1 · mm Hg
RDN vs Sham
treatment difference −3.2 mm Hg (95% CI −6.3 to 0.0); P = 0.0487
As reported in the abstract
Secondary outcomes
Mean, mm Hg
| Outcome | RDN | Sham | difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Change in office SBP · 3 months | −12.7 (SD 18.3) | −9.7 (SD 17.3) | −3.0 (−7.0 to 1.0) | P = 0.173 | |
| −10−505Difference (linear scale) |
Primary end point across predefined subgroups
- No significant interaction across predefined subgroups
Ambulatory and office DBP
- No significant differences in ambulatory or office DBP
Medication changes and adherence
- No significant between-group differences in medication changes or patient adherence
Safety
| Outcome | RDN | Sham |
|---|---|---|
| Accessory renal artery dissection · through 6 months | 0.7% | Not reported in the abstract |
Accessory renal artery dissection · through 6 months
- Adverse safety events uncommon
Original publication
Effect of Alcohol-Mediated Renal Denervation on Blood Pressure in the Presence of Antihypertensive Medications: Primary Results From the TARGET BP I Randomized Clinical Trial. Circulation. Published 8 April 2024. doi:10.1161/circulationaha.124.069291
Summarised from the published abstract; every number is checked against it