Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial
Key result
Endovascular ultrasound renal denervation lowers daytime ambulatory SBP by ~6 mm Hg versus sham.
- Difference -6.3 mm Hg
- 95% CI -9.4 to -3.1
- P=0.0001
- n=146
Why the study?
It was unknown whether endovascular ultrasound renal denervation reduces ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications.
Does endovascular ultrasound renal denervation reduce daytime ambulatory systolic blood pressure in patients with combined systolic-diastolic hypertension off medications?
Population
146 patients with combined systolic-diastolic hypertension off antihypertensive medications
Comparison
Endovascular ultrasound renal denervation vs sham procedure with renal angiography only
Design
Multicentre, international, single-blind, randomised, sham-controlled trial
Follow-up
2 months
Authors
Discussion
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Implication
May support renal denervation as adjunctive hypertension therapy; leaves open long-term durability and optimal patient selection.
Key Points
- Investigate if endovascular ultrasound renal denervation reduces ambulatory blood pressure in hypertensive patients without antihypertensive medications.
- Multicentre, international, single-blind, randomised, sham-controlled trial conducted at 39 centres (21 in the USA and 18 in Europe).
- Randomised 146 patients with combined systolic-diastolic hypertension (135/85 to 170/105 mm Hg) to renal denervation (n=74) or sham procedure (n=72) using computer-generated sequence.
- Primary endpoint: change in daytime ambulatory systolic blood pressure at 2 months in intention-to-treat population.
- Renal denervation resulted in a reduction of -8.5 mm Hg (SD 9.3) in daytime ambulatory systolic blood pressure compared to -2.2 mm Hg (SD 10.0) for sham (baseline-adjusted difference: -6.3 mm Hg, 95% CI -9.4 to -3.1, p=0.0001).
- No major adverse events were reported in either group.
Study Design
Type
RCT (n=146)
Blinding
Single-blind
Randomization
1:1
Multicenter
Yes
Structured PICO
Does endovascular ultrasound renal denervation reduce daytime ambulatory systolic blood pressure in patients with combined systolic-diastolic hypertension off medications?
P
Population
146 patients aged 18-75 years with combined systolic-diastolic hypertension off antihypertensive medications, followed for 2 months.
I
Intervention
Endovascular ultrasound renal denervation
C
Comparator
Sham procedure consisting of renal angiography only
O
Outcome
Change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat populationsurrogate
Main Result
Mean Difference: -6.3 (95% CI -9.4–-3.1)
Absolute Event Rate: -8.5% vs -2.2%
p-value: p=0.0001
Endovascular ultrasound renal denervation significantly reduces ambulatory blood pressure at 2 months compared to a sham procedure in patients with mild-to-moderate hypertension off medications.
Cite This Study
Azizi et al. (2018) conducted an RCT in Combined systolic-diastolic hypertension (n=146). Endovascular ultrasound renal denervation vs. Sham procedure (renal angiography only) was evaluated on Change in daytime ambulatory systolic blood pressure at 2 months (Difference -6.3 mm Hg, 95% CI -9.4 to -3.1, p=0.0001). Endovascular ultrasound renal denervation significantly reduced daytime ambulatory systolic blood pressure compared with a sham procedure (difference -6.3 mm Hg; 95% CI -9.4 to -3.1; p=0.0001).