Table 1

Randomised sham-controlled trials of renal denervation in humans

Study name and (year)
ClinicalTrials.gov Identifier		No of patientsExperimental designHypertension phenotypeDenervation technology and number of ablationsPrimary BP endpointChange in primary EP
(mm Hg)
p for baseline-adjusted treatment difference
RADIANCE HTN-SOLO20 (2018)
NCT02649426		146Multicentre RCT: single blind (participant)
Sham: renal angiogram		Combined mild–moderate systolic–diastolic HTN: off medsPARADISE balloon cooled
US catheter
5 US emissions per patient		Daytime ASBP reduction at 8 weeksRDN −8.5 SHAM −2.2 p=0.0001
REDUCE-HTN: REINFORCE21(2018)
NCT02392351		51Multicentre RCT: single blind (participant)
Sham: renal angiogram		Mild–moderate systolic HTN: off medsVessix balloon catheter, helical bipolar RF electrodes
14 ablations per patient		24 hours ASBP reduction at 8 weeksRDN −5.3 SHAM −8.5 p=0.08
(interim analysis)
SPYRAL ON MED18 (2018)
NCT02439775		80Multicentre RCT: single blind (participant)
Sham: renal angiogram		Combined mild–moderate systolic–diastolic HTN: on medsSPYRAL multielectrode
RF catheter
46 ablations per patient		24 hours ASBP reduction at 6 monthsRDN −9.0 SHAM −1.6
p=0.006
SPYRAL OFF MED16 (2017)
NCT02439749		80Multicentre RCT: single blind (participant)
Sham: renal angiogram		Combined mild–moderate systolic–diastolic HTN: off medsSPYRAL multielectrode
RF catheter
44 ablations per patient		24 hours ASBP reduction at 3 monthsRDN −5.5 SHAM −0.5
p=0.04
WAVE IV38 (2016)
NCT02029885		81Multicentre RCT: double blind,
Sham: diagnostic US		Mild–moderate systolic HTN: on medsExternal low intensity focused US,
14 US emissions per artery		Office SBP reduction at 6 monthsRDN −12.9 SHAM −22.7
p=0.13
(interim analysis)
RESET39 (2016)
NCT01459900		69Single centre RCT: double blind,
Sham: renal angiogram		Mild–moderate systolic HTN: on medsUnipolar Symplicity Flex
RF catheter
10 ablations per patient		Daytime ASBP reduction at 3 monthsRDN −6.2 SHAM −6.0
p=0.95
RDN in mild resistant HTN40 (2015)
NCT01656096		71Single centre RCT: double blind,
Sham: renal angiogram		Mild systolic HTN: on MedsUnipolar Symplicity Flex
RF catheter
11 ablations per patient		24 hours ASBP reduction at 6 monthsRDN −7.0 SHAM −3.5
p=0.15
Symplicity HTN37 (2014)
NCT01418261		535Multicentre RCT: single blind (participant)
Sham: renal angiogram		Moderate–severe systolic HTN: on medsUnipolar Symplicity Flex
RF catheter
11 ablations per patient		Office SBP reduction at 6 monthsRDN −14.1 SHAM −11.3
p=0.26

  • The term resistant hypertension has not been used as these trials did not apply the current definition of resistant hypertension as inclusion criteria.35

  • ASBP, ambulatory systolic blood pressure; HTN, hypertension; RCT, randomized controlled trial; RF, radiofrequency; SBP, systolic blood pressure; US, ultrasound.