Table 2

Randomised trials of renal denervation in humans without sham

Study name and (year)
ClinicalTrials.gov Identifier		No of patientsExperimental designHypertension phenotypeDenervation technology and No of ablationsPrimary BP endpointChange in primary EP (mm Hg)
p for baseline-adjusted treatment difference
RADIOSOUND24 (2018)
NCT02920034
RF vs US RDN		120Single centre three arm randomised trial: single blindModerate systolic HTN: on medsSPYRAL multielectrode RF catheter:
17/35 ablations per patient (RFM-RDN/RFB-RDN)
PARADISE balloon cooled US catheter: 6 ablations per patient		Daytime Mean ASBP reduction at 3 monthsRFM-RDN −6.5
RFB-RDN −8.3
US −13.2
p only significant for US vs RFB-RDN
RDN OSA41 (2018)
NCT01366625
RDN vs standard pharmacotherapy in patients with moderate to severe OSA		60Single centre RCT: open label, blinded endpoint evaluationModerate systolic HTN: on meds
Moderate–severe OSA		Unipolar Symplicity Flex
RF catheter
12 ablations per patient		Office SBP reduction at 3 monthsRDN −22.0 Control −5.0
p=0.002
INSPiRED42 (2017)
NCT01505010
RDN vs standard pharmacotherapy		15Three centre RCT: open label, blinded endpoint evaluationCombined mild–moderate systolic–diastolic HTN: on medsEnligHTN multielectrode
RF catheter
8–24 ablations per patient		24 hours ASBP reduction at 6 monthsRDN −21.7 Control 0.7
p=0.018
SYMPATHY43 (2017)
NCT01850901
RDN vs standard pharmacotherapy		139Multicentre RCT: open label, blinded endpoint evaluationModerate–serve systolic HTN: on medsEnligHTN multielectrode or Symplicity Flex RF catheters
15 ablations per patient		Daytime Mean ASBP reduction at 6 monthsRDN −6.0 Control −7.9
p=0.625
DENERVHTA44 (2016)
NCT02039492
RDN vs spironolactone		24Three centre RCT: open label, blinded endpoint evaluationModerate–severe systolic HTN: on medsUnipolar Symplicity Flex
RF catheter:
8–12 ablations per patient		24 hours ASBP reduction at 6 monthsRDN −5.7 Control −23.6
p=0.01
PRAGUE-1545 (2015)
NCT 01560312
RDN vs optimised pharmacotherapy		106Multicentre randomised trial, open label, blinded endpoint evaluationModerate systolic HTN: on medsUnipolar Symplicity Flex
RF catheter:
11 ablations per patient		24 hours ASBP reduction at 6 monthsRDN −8.8 Control −8.1
p=0.87
DENER-HTN22 (2015)
NCT01570777
RDN vs optimised pharmacotherapy		106Multicentre RCT: open label, blinded endpoint evaluationModerate–severe systolic HTN: on medsUnipolar Symplicity Flex
RF catheter:
11 ablations per patient		Daytime Mean ASBP reduction at 6 monthsRDN −15.8 Control −9.9
p=0.03
HTN JAPAN46 (2015)
NCT01644604
RDN vs standard pharmacotherapy		41Multicentre randomised trial, open label, blinded endpoint evaluationSevere systolic HTN: on medsUnipolar Symplicity Flex
RF catheter:
11 ablations per patient		Office SBP reduction at 6 monthsRDN −16.6 Control −7.9
p=0.169
Early termination due to
Symplicity HTN-3 result
RDN OSLO47 (2013)
NCT01673516
RDN vs optimised pharmacotherapy		20Single centre RCT, open label, blinded endpoint evaluationTrue treatment resistant HTNUnipolar Symplicity Flex
RF catheter:
8 ablations per artery		Office SBP reduction at 6 monthsRDN −8.0 Control −28.0
p=0.08
Early termination (ethical reasons)
Symplicity HTN-25 (2010)
NCT00888433
RDN vs standard pharmacotherapy		106Multicentre RCT: open label, blinded endpoint evaluationSevere systolic HTNUnipolar Symplicity Flex
RF catheter:
8–12 ablations per patient		Office SBP reduction at 6 monthsRDN −32 Control 1
p=0.0001

  • ASBP, ambulatory systolic blood pressure; HTN, hypertension; RCT, randomised controlled trial; RF, radiofrequency; RFB-RDN, radiofrequency renal denervation to main renal artery, branches and accessories; RFM-RDN, radiofrequency renal denervation to main renal artery; SBP, systolic blood pressure; US, ultrasound.