August 11, 2026The Lancet
Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial
Key result
Renal denervation reduces 24-hour SBP by ~7 mmHg versus sham in uncontrolled hypertension.
- MD -7.0 mmHg
- 95% CI -12.0, -2.1
- P=0.0059
- n=80
Why the study?
Previous catheter-based renal denervation studies reported variable efficacy results, leaving its safety and blood pressure-lowering response uncertain in patients with uncontrolled hypertension on antihypertensive medications.
Does renal denervation reduce blood pressure in patients with uncontrolled hypertension on one to three antihypertensive drugs?
Population
First 80 patients with uncontrolled hypertension on one to three antihypertensive drugs
Comparison
Renal denervation vs sham control
Design
International, randomised, single-blind, sham-control proof-of-concept trial
Follow-up
6 months
Authors
Discussion
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Implication
May support adjunctive BP control on meds; leaves open confirmation before practice change.
Key Points
- This trial aimed to assess the efficacy and safety of renal denervation in patients with uncontrolled hypertension already on antihypertensive medications.
- Randomised, single-blind, sham-control trial conducted in 25 centres across multiple countries.
- Enrolled patients aged 20-80 with uncontrolled hypertension on stable doses of antihypertensive drugs for at least 6 weeks.
- Primary efficacy endpoint was blood pressure change from baseline at 6 months, assessed via ambulatory measurements.
- Renal denervation group experienced significant reductions in 24 h systolic blood pressure by -7.0 mm Hg (p=0.0059) and office systolic blood pressure by -6.6 mm Hg (p=0.0250).
- No major adverse events were recorded in either group.
- Medication adherence averaged around 60%, with variability among participants.
Study Design
Type
RCT (n=80)
Blinding
Double-blind
Randomization
1:1 block randomization
Multicenter
Yes
Structured PICO
Does renal denervation reduce blood pressure in patients with uncontrolled hypertension on one to three antihypertensive drugs?
P
Population
80 patients aged 20 to 80 years with uncontrolled hypertension despite 1 to 3 antihypertensive medications, followed for 6 months.
I
Intervention
Catheter-based renal denervation in the main renal arteries and branches.
C
Comparator
Sham control (renal angiography).
O
Outcome
Blood pressure change from baseline based on 24 h ambulatory blood pressure measurements assessed at 6 months.surrogate
Main Result
Mean Difference: -7 (95% CI -12–-2.1)
p-value: p=0.0059
Renal denervation significantly reduces ambulatory and office blood pressure at 6 months in patients with uncontrolled hypertension despite concurrent use of 1 to 3 antihypertensive medications.
Limitations
- Incomplete medication adherence was common and varied for individual patients throughout the study.
- Small sample size as a proof-of-concept trial with no powered endpoints.
Cite This Study
Kandzari et al. (2018) conducted an RCT in Uncontrolled hypertension (n=80). Renal denervation vs. Sham control was evaluated on Change in 24-hour systolic blood pressure at six months (MD -7.0 mmHg, 95% CI -12.0, -2.1, p=0.0059). Renal denervation significantly reduced 24-hour systolic blood pressure by a mean difference of 7.0 mmHg compared to sham control at 6 months in patients with uncontrolled hypertension on medications.