Alcohol-mediated renal denervation in patients with hypertension in the absence of antihypertensive medications
Primary result · Change in 24-h SBPResult — go to the resultMean between-group difference 1.5 mmHgAuthors' conclusion
In this trial, alcohol-mediated RDN was delivered safely but was not associated with significant BP differences between groups. Medication burden was lower in the RDN group up to 12 months.
Study context
- Population
- Patients with hypertension (24-h SBP 135–170 mmHg, office SBP 140–180 mmHg, DBP ≥90 mmHg) on 0–2 antihypertensive medications, assessed after medication washoutrandomised
- Participants
- 106 patients
- Comparison
- Alcohol-mediated renal denervation (RDN) vs sham
- Primary endpoint
- Change in mean 24-h SBP
- Follow-up
- 8 weeks
Methodological detailsblinded, sham-controlled, multicentre (25 centres, Europe and USA)
- Blinded
- Sham-controlled
- Multicentre (25 centres, Europe and USA)
Primary result
Change in 24-h SBP
Mean between-group difference
1.5 mmHg
P = 0.27
Change by group
RDN
â2.9
mean · SD 7.4 · mmHg
Sham
â1.4
mean · SD 8.6 · mmHg
As reported in the abstract
Further findings
Office SBP, with medication escalation · up to 12 months · blinded follow-up
P = 0.68
| Outcome | RDN | Sham | P value |
|---|---|---|---|
| Medication burden (mean daily defined dose) · up to 12 monthsSignificantly lower with RDN | mean 1.5 ± 1.5 | mean 2.3 ± 1.7 | P = 0.017 |
Safety
Safety events (incl. major adverse events up to 30 days)
- No differences in safety events between groups
Original publication
Alcohol-mediated renal denervation in patients with hypertension in the absence of antihypertensive medications. EuroIntervention. Published 18 September 2023. doi:10.
Summarised from the published abstract; every number is checked against it