Table 2

Ongoing sham-controlled RCTs (as of June 2022)

Trial, NCT*Catheter systemDesign, (randomisation ratio)Sample sizeInclusion criteriaPrimary efficacy outcomeEstimated trial completion
SPYRAL HTN-ON MED Expansion, NCT02439775Symplicity Spyral (multi-electrode RF)Bayesian adaptive design, RDN vs sham (1:1)340Uncontrolled office and 24-hour BP on 1-3 antihypertensive drugsChange in 24-hour SBP at 6 months2026
RADIANCE II, NCT03614260Paradise (US)RDN vs sham
(1:1)
225Uncontrolled stage II hypertension (office and daytime ambulatory BP) in absence of antihypertensive drugsChange in daytime ambulatory SBP at 2 months2022
TARGET BP OFF-MED, NCT03503773Peregrine (ethanol injection via microneedles)RDN vs sham
(1:1)
90Uncontrolled office and 24-hour BP in absence of antihypertensive drugsChange in 24-hour ambulatory SBP at 2 months2023
TARGET BP I, NCT02910414Peregrine (ethanol injection via microneedles)RDN vs sham
(1:1)
300Uncontrolled office and 24-hour BP on 2-5 antihypertensive drugsChange in ambulatory 24-hour SBP at 3 months2025
Trial, NCT*Catheter systemDesign, (randomisation ratio)Sample sizeInclusion criteriaPrimary efficacy outcomeEstimated trial completion
SPYRAL HTN-ON MED Expansion, NCT02439775Symplicity Spyral (multi-electrode RF)Bayesian adaptive design, RDN vs sham (1:1)340Uncontrolled office and 24-hour BP on 1-3 antihypertensive drugsChange in 24-hour SBP at 6 months2026
RADIANCE II, NCT03614260Paradise (US)RDN vs sham
(1:1)
225Uncontrolled stage II hypertension (office and daytime ambulatory BP) in absence of antihypertensive drugsChange in daytime ambulatory SBP at 2 months2022
TARGET BP OFF-MED, NCT03503773Peregrine (ethanol injection via microneedles)RDN vs sham
(1:1)
90Uncontrolled office and 24-hour BP in absence of antihypertensive drugsChange in 24-hour ambulatory SBP at 2 months2023
TARGET BP I, NCT02910414Peregrine (ethanol injection via microneedles)RDN vs sham
(1:1)
300Uncontrolled office and 24-hour BP on 2-5 antihypertensive drugsChange in ambulatory 24-hour SBP at 3 months2025

*NCTs found at ClinicalTrials.gov. BP: blood pressure; RDN: renal denervation; RF: radiofrequency; SBP: systolic blood pressure; US: ultrasound

Table 2

Ongoing sham-controlled RCTs (as of June 2022)

Trial, NCT*Catheter systemDesign, (randomisation ratio)Sample sizeInclusion criteriaPrimary efficacy outcomeEstimated trial completion
SPYRAL HTN-ON MED Expansion, NCT02439775Symplicity Spyral (multi-electrode RF)Bayesian adaptive design, RDN vs sham (1:1)340Uncontrolled office and 24-hour BP on 1-3 antihypertensive drugsChange in 24-hour SBP at 6 months2026
RADIANCE II, NCT03614260Paradise (US)RDN vs sham
(1:1)
225Uncontrolled stage II hypertension (office and daytime ambulatory BP) in absence of antihypertensive drugsChange in daytime ambulatory SBP at 2 months2022
TARGET BP OFF-MED, NCT03503773Peregrine (ethanol injection via microneedles)RDN vs sham
(1:1)
90Uncontrolled office and 24-hour BP in absence of antihypertensive drugsChange in 24-hour ambulatory SBP at 2 months2023
TARGET BP I, NCT02910414Peregrine (ethanol injection via microneedles)RDN vs sham
(1:1)
300Uncontrolled office and 24-hour BP on 2-5 antihypertensive drugsChange in ambulatory 24-hour SBP at 3 months2025
Trial, NCT*Catheter systemDesign, (randomisation ratio)Sample sizeInclusion criteriaPrimary efficacy outcomeEstimated trial completion
SPYRAL HTN-ON MED Expansion, NCT02439775Symplicity Spyral (multi-electrode RF)Bayesian adaptive design, RDN vs sham (1:1)340Uncontrolled office and 24-hour BP on 1-3 antihypertensive drugsChange in 24-hour SBP at 6 months2026
RADIANCE II, NCT03614260Paradise (US)RDN vs sham
(1:1)
225Uncontrolled stage II hypertension (office and daytime ambulatory BP) in absence of antihypertensive drugsChange in daytime ambulatory SBP at 2 months2022
TARGET BP OFF-MED, NCT03503773Peregrine (ethanol injection via microneedles)RDN vs sham
(1:1)
90Uncontrolled office and 24-hour BP in absence of antihypertensive drugsChange in 24-hour ambulatory SBP at 2 months2023
TARGET BP I, NCT02910414Peregrine (ethanol injection via microneedles)RDN vs sham
(1:1)
300Uncontrolled office and 24-hour BP on 2-5 antihypertensive drugsChange in ambulatory 24-hour SBP at 3 months2025

*NCTs found at ClinicalTrials.gov. BP: blood pressure; RDN: renal denervation; RF: radiofrequency; SBP: systolic blood pressure; US: ultrasound

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